EFFECT OF PHILIPS SONICARE AIRFLOSS ON PLAQUE INDEX, GINGIVAL INFLAMMATION, AND BLEEDING INDEX IN PATIENTS WITH FIXED ORTHODONTIC APPLIANCES

Joshua D. Bruce, D.D.S.

An Abstract Presented to the Graduate Faculty of Saint Louis University in Partial Fulfillment of the Requirements for the Degree of Master of Science in Dentistry 2013

Abstract Objective: This four week, randomized, single-blinded, split mouth clinical trial in orthodontic patients compared interproximal cleaning using a Philips Sonicare AirFloss (AF) and manual toothbrushing (MT), to flossing (F) and MT in order to determine which regimen was more effective in reducing supragingival plaque and bleeding on probing. Patient preference and compliance for the AF was compared to F. Methods: Forty subjects participated in a four week trial, and were randomly assigned in a left/right split mouth design to perform plaque control on one half using MT and F, and the other half using MT and AF. Written and verbal instructions were given to brush for two minutes, 2/day and to F 1x/day on half and to use the AF on the other half (from facial and lingual). Data was collected at baseline (T0) and four weeks (T1). Whole mouth gingival health was scored using the Lobene Modified Gingival Index (MGI). To compare interproximal cleaning methods, each half was scored for the Turnsky Modified Plaque Index (MPI) and the Papillary Bleeding Index (PBI). Subjects completed a survey with a Visual Analogue Scale to indicate preference between F and AF and questions estimating frequency of use of F and AF after completing the study. Between-method comparisons at T0 and T1 were made by a one tailed, two-sample F-test for variances. Within-group comparisons were made at T0 and T1 by a paired two-sample, two tailed ttest for means. Results: Survey Data: Patients strongly preferred (78%) the AF over F. They used the AF 82% more than F (F: 3.1 times/week vs. AF: 5.6 times/week). MGI: A significant (19%) decrease in whole mouth MGI occurred. MPI: A decrease in MPI occurred for both methods (F: 6.3%, AF: 4.2%) but no significant change in MPI

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within or between methods. PBI: A significant decrease in PBI of 50% occurred for both methods from T0 to T1, but no significant difference occurred between methods. Conclusions: 1. Patients strongly preferred (78%) the AirFloss over flossing. 2. Patients would use the AirFloss 82% more than flossing. 3. The AirFloss is as effective in reducing interproximal bleeding as flossing.

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EFFECT OF PHILIPS SONICARE AIRFLOSS ON PLAQUE INDEX, GINGIVAL INDEX, AND BLEEDING INDEX IN PATIENTS WITH FIXED ORTHODONTIC APPLIANCES

Joshua D. Bruce, D.D.S.

A Thesis Presented to the Graduate Faculty of Saint Louis University in Partial Fulfillment of the Requirements for the Degree of Master of Science in Dentistry 2013

COMMITTEE IN CHARGE OF CANDIDANCY: Associate Professor Ki Beom Kim, Chairperson and Advisor Associate Professor D. Douglas Miley Associate Clinical Professor Donald R. Oliver

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Dedication I dedicate this thesis to my wonderful family. You have allowed me to fulfill my dream of becoming an orthodontist and for that I will be forever grateful. To my parents, Rick and Karen, whose appreciation and respect for education has guided and driven me to succeed. Without the constant support and prodding of my dad, I would not be here today. Finally, to my older brothers Carl and Richard and my younger sisters and brother especially my sister Emily, I thank each of you for all the support and guidance for me throughout this long journey. You are all so unique and have helped shape me into the individual I am today.

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Acknowledgements I’d like to thank my thesis committee for all their efforts and guidance during this entire process. Thank you Dr. Kim, for your supervision and direction from the very beginning and for your willingness to take a gamble on this project, from overseeing this research topic to approving the final version of this thesis. This project would not have been possible without your support and belief in me. Your tireless effort, cheerful demeanor, and friendly advice are appreciated more than you will ever know. Thank you Dr. Miley, for being the ever-present source of help and consultation for all the periodontics questions that arose throughout this project. It has been an honor and privilege to study under your guidance. Thank you Dr. Oliver, for your assistance with finding all the grammar and formatting mistakes that so easily ensnare me and sharing your knowledge of orthodontic research. Thank you Heidi Israel, for all your help in analyzing and interpreting the statistics for the study. Finally, I would like to thank Dr. Marilyn Ward and Philips Sonicare for the generous donation of equipment and gifts for each of the subjects participating in this project. Without your support, this project could never have been initiated.

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Table of Contents LIST OF TABLES ..................................................................................... vi LIST OF FIGURES .................................................................................. vii CHAPTER 1: INTRODUCTION ....................................................................................... 1 Problem of Hygiene in Orthodontic Patients .............................................. 1 Effect of Poor Oral Hygiene in Orthodontic Patients ................................. 1 Oral Irrigator, a Device to Improve the Oral Hygiene in All Patients ........ 3 The Philips Sonicare AirFloss, a New Interproximal Cleaning Device ..... 3 CHAPTER 2: REVIEW OF THE LITERATURE ............................................................. 5 How Does Plaque Interact with the Oral Environment? ............................. 5 How Well Does Brushing and Flossing Remove Plaque Biofilm and What Are the Oral Hygiene Habits of the Public? ............................................... 7 What are the Effects of Interdental Cleaning on Gingival Health? ............ 8 How Does Orthodontic Treatment Affect Plaque and Gingival Health? . 11 Patient Oral Hygiene Compliance ............................................................ 15 What Methods Can an Orthodontist Employ to Increase Motivation, Oral Hygiene, and Compliance in Orthodontic Patients? What Role Does the Device Play in Compliance? ..................................................................... 17 Is There a Proper Way to Measure Plaque in Orthodontic Patients and How Do Plaque Levels Change throughout Treatment? Does Hygiene During Orthodontic Treatment Affect Long-term Oral Hygiene Habits? 22 Hawthorne Effect ...................................................................................... 25 Can Oral Hygiene Compliance During Treatment be Reflective of Compliance with Other Prescribed Tasks During Treatment as well as Overall Treatment Time? .......................................................................... 26 Evaluation of a New Interproximal Cleaning Device ............................... 27 References Cited ....................................................................................... 33 CHAPTER 3: JOURNAL ARTICLE ............................................................................... 40 Abstract ..................................................................................................... 40 Introduction ............................................................................................... 42 Materials and Methods .............................................................................. 43 Sample: ......................................................................................... 43 Subject/Sample Inclusion, Recruitment, and Selection Criteria: .. 43 Forms and Approvals: ................................................................... 44 Groups: .......................................................................................... 44 Randomization: ............................................................................. 45 Study Blindness: ........................................................................... 45 Research Design: .......................................................................... 45 Modified Gingival Index: ............................................................. 47 Modified Plaque Index:................................................................. 48 Papillary Bleeding Index: ............................................................. 49 Inter-Rater Reliability ................................................................... 50 Statistical Analysis .................................................................................... 51 Between Group Comparisons: ...................................................... 51 iv

Within Group Comparisons: ......................................................... 51 Significance Level: ....................................................................... 52 Inter Rater Reliability ................................................................... 52 Results ....................................................................................................... 52 Whole Mouth Clinical Data: ......................................................... 55 Modified Gingival Index: ............................................................. 57 Modified Plaque Index:................................................................. 57 Papillary Bleeding Index: ............................................................. 58 Discussion ................................................................................................. 58 Survey Data - Preference and Compliance: .................................. 58 Clinical Data: MGI, MPI, and PBI ........................................................... 60 MGI: .............................................................................................. 60 MPI: .............................................................................................. 60 PBI: ............................................................................................... 61 General Comparisons with Other Studies: .................................... 62 Conclusions ............................................................................................... 65 References Cited ....................................................................................... 66 APPENDIX ....................................................................................................................... 69 Appendix: Patient Preference Survey ....................................................... 69 VITA AUCTORIS ............................................................................................................ 70

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LIST OF TABLES Table 3-1: Survey Data for Compliance, Preference, and Estimates for Flossing/Week before the Study and Flossing and AirFlossing/Week after the Study ............................. 52 Table 3-2: Two-Sample F-Test for Variances Comparing Self-reported Flossing and AirFlossing Compliance During the Study, Estimated Times/Week to Either Floss or Use the AirFloss After the Study if Not Made to, and Comparing Self-reported Flossing Habits Before and After the Study .................................................................................... 55 Table 3-3: Descriptive Statistics for MGI, MPI, and PBI................................................. 55 Table 3-4: F-Test Two-Sample for Variances for PBI and MPI at T0 and T1 ................. 56 Table 3-5: t-Test: Paired Two Sample for Means for MGI, MPI, and PBI at T0 and T1. 56 Table 3-6: Percent Change in MGI and PBI and MPI for Flossing and AirFlossing Sides ........................................................................................................................................... 57

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LIST OF FIGURES Figure 3-1: Modified Plaque Index Scoring (Turesky Modification of Quigley Hein Index) ................................................................................................................................ 49 Figure 3-2: Papillary Bleeding Index Scoring .................................................................. 50 Figure 3-3: Histogram of VAS Reported Preference for Using Floss Compared to AirFloss ............................................................................................................................. 53 Figure 3-4: Frequency of Estimated Number of Times/Week to Either Floss or Use the AirFloss if not Made to for a Study if Only One Option Available at a Time ................. 54

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CHAPTER 1: INTRODUCTION Problem of Hygiene in Orthodontic Patients Proper oral hygiene in patients can be particularly difficult to attain, especially in patients wearing fixed orthodontic appliances. It is often recommended that to maintain good oral health during orthodontic treatment requires a rigorous regimen of brushing after every meal and at night and either flossing or using an alternative interdental cleaning device such as a Waterpik Water Flosser, at least once a day. If proper oral hygiene is not maintained, gingival overgrowth, gingival bleeding, and white spots or smooth surface caries may become a problem. Proper oral hygiene is always a difficult task to instill into the behavioral patterns of individuals, in particular those who fall into special needs categories, such as diabetes, immunocompromised, orthodontics, periodontal maintenance, dental implants, crown and bridge, physically and mentally disabled, the elderly, and the very young. Educating patients regarding effective ways to perform oral hygiene using techniques and products that will be adhered to is challenging but absolutely necessary in order to prevent adverse outcomes of gingivitis, periodontitis, bacteremia, white spot lesions (WSLs), caries, and tooth loss.

Effect of Poor Oral Hygiene in Orthodontic Patients As reported by Sandvik and colleagues in Norway, within patients with fixed orthodontic appliances, greater than 50% of subjects may experience an increase in WSLs, about 50% of orthodontic patients developed one or more WSLs during treatment, and 5.7% of the teeth were affected. In non-orthodontic patients, 11% developed WSLs

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on the labial surfaces in the same period of time and 0.4% of the teeth were affected.1 This conclusion was further supported by additional studies showing that greater than 50% of subjects might experience an increase in the incidence of WSLs with fixed orthodontic appliances.2-4 Richter and colleagues found that the average incidence for developing a WSL during orthodontic treatment was 72.9% and 2.3% had cavitated lesions. They found that the longer the treatment, the higher the incidence of WSLs and cavitated lesions. They found no association with sex, age, extractions, or fluoridation sources. However, initial oral-hygiene score was moderately associated with the incidence of WSLs.5 Boersma and colleagues reported that 97% of all subjects and 30% of the buccal surfaces had demineralization after orthodontic treatment, identified by using quantitative light-induced fluorescence (QLF, Diagnodent). In these patients, 40% of the surfaces in males and 22% in females showed WSLs, and surface enamel was changed in almost every orthodontic patient.6 In an older study using banded teeth, B. Zachrisson and S. Zachrisson found that caries frequency was not markedly affected by orthodontic appliances. However, the vast majority of carious lesions were observed in relatively few patients.7 Øgaard, Rolla, and Arends reported that WSLs develop very rapidly, and visible WSLs can be induced experimentally without fluoride within 4 weeks. Therefore proper oral hygiene in orthodontic patients is imperative to prevent demineralization and gingival inflammation.8

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Oral Irrigator, a Device to Improve the Oral Hygiene in All Patients In an effort to better serve his patients, Dr. Gerald Moyer, a dentist in Ft. Collins, Colorado, and hydraulic engineer John Mattingly invented the dental water jet in the 1950s and introduced the oral irrigator to the dental community during the 1962 Dallas Dental Convention.9-11 Since that time numerous studies have been published in peer reviewed journals evaluating the efficacy of the dental water jet from Water Pik, Inc., Fort Collins, Colorado, as well as other forms and brands of oral irrigating devices.

The Philips Sonicare AirFloss, a New Interproximal Cleaning Device In 2010, Philips Sonicare began clinical studies of a new interdental cleaning device named the AirFloss. Nearly 50 years after the dental water jet was introduced, Philips introduced the Sonicare AirFloss during the opening day of the 34th International Dental Show in Cologne Germany in March 2011. Although this device was categorized by the FDA under the same designation as an oral irrigator, thereby categorizing it as safe to use without undergoing clinical trials, it is fundamentally a very different device from traditional oral irrigators. The AirFloss is a battery powered device that stores two teaspoons of liquid in the handle and delivers bursts of aerosolized water micro-droplets using compressed air. The micro-droplets disrupt and remove biofilm from between teeth. One teaspoon of liquid is enough to clean the interproximal surfaces of both dental arches. Water or other liquid medicaments such as chlorohexidine can be used.12 This capability could make the AirFloss ideal for delivering antimicrobials between teeth. However, there have been no published journal articles to date evaluating the AirFloss in this capacity.

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This product is being marketed as an excellent alternative to flossing for daily interproximal cleaning. To date there have been no published studies comparing the effectiveness, compliance, or preference of the AirFloss to traditional brushing or to toothbrushing and flossing in the orthodontics patient with fixed orthodontic appliances. However, before accessing what studies have been performed to date for the AirFloss, perhaps one should consider the following: what is plaque; how does plaque interact with the oral environment to induce gingival changes; how does brushing and flossing alter the plaque biofilm and re-establish and maintain proper oral hygiene; what changes occur in the oral environment when braces are introduced; how can compliance and motivation be maintained and enhanced during orthodontic treatment; and finally, what has research shown to date for the AirFloss? Then the AirFloss should be evaluated for its use in orthodontic patients with fixed appliances.

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Chapter 2: REVIEW OF THE LITERATURE How Does Plaque Interact with the Oral Environment? In a seminal study on the formation of plaque, it was seen that plaque formation began in the interproximal areas of the premolars and molars and then in the interproximal areas of the anterior teeth and facial surfaces of the premolars and molars.13 Incidentally, the teeth most affected by WSLs are the first molars, upper lateral incisors, and lower canines.8 “Gingival inflammation generally started in the interproximal areas of the premolars and molars and in the facial gingiva of the premolars and canines, and the anterior interproximal and the facial and oral molar areas subsequently developed gingivitis” 13 The study also showed that good gingival health could be maintained if effective oral hygiene was performed at intervals up to 48 hours. After 48 hours between brushing, gingivitis begins to develop. This means that it is more important to have complete plaque removal once every two days than to perform frequent ineffective oral hygiene. This is the same point in time that bacteria changes from predominately gram positive to gram negative.14, 15 However, as previously noted, plaque removal is often inadequate and “the average person is not an effective brusher and probably lives with larger amounts of plaque on his teeth constantly, even though he brushes once every day”.16 In addition, plaque accumulation on the tooth surface is the direct cause of gingivitis.15 Gingivitis also resolves when plaque control measures are resumed.14 In this study, students with healthy gingiva were instructed to abstain from all oral hygiene. This resulted in marginal gingivitis in all subjects within 10-21 days and changes in the

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composition of oral flora. After oral hygiene was re-instigated, the gingival returned to normal as well as the bacterial flora. Therefore, maintaining good mechanical oral hygiene remains the best way to prevent gingivitis.17 It is also reasonable to assume that longer exposure of the gingiva to plaque results in greater gingival irritation and presumably in higher rates of interproximal caries. A study by Schwarz and colleagues reviewing established interproximal cleaning methods drew the following conclusion: Floss is the most widely used method of interdental cleaning and the American Dental Association reports that up to 80% of interdental plaque may be removed by this method, resulting in a significantly reduced incidence of caries and prevention of periodontal disease. The main problem with all interdental cleaning is, however, patient ability and motivation. Patients are known to find flossing difficult, especially where there are tight contact points, and therefore interdental cleaning does not readily become an established part of daily oral hygiene. As such, there is a need for new techniques/devices to be developed that will make interdental cleaning easier and improve patient motivation.18 However, studies were not found to substantiate an increased rate of interproximal caries or periodontal disease in patients who did not floss. Many studies show a significant increase in the number of WSLs during treatment with a rapid increase during the first six months followed by a slower rate of incidence up to 12 months.5, 19, 20 It is interesting to note that patterns of toothbrushing are habitual and do not vary.21, 22 This means that a patient may continue to brush in the exact same manner even if instructed to brush differently. This can be important for orthodontic patients because they should change the way they brush with braces on in order to effectively clean around the cervical areas of the brackets; however, they may in fact not change their habits even if instructed how to properly brush.

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How Well Does Brushing and Flossing Remove Plaque Biofilm and What Are the Oral Hygiene Habits of the Public? Although patients are routinely instructed to brush and floss to achieve the necessary oral hygiene, is there actually a scientific benefit to flossing for reducing plaque, gingivitis, carries, and periodontal disease? The reasoning to consider interproximal cleaning as a necessary adjunct to brushing is that toothbrushing alone is considered to be best capable of thoroughly cleaning the flat areas of the teeth.17, 23 This includes the buccal, lingual, and occlusal surfaces with the exception of the pits and fissures. This leaves the interproximal areas basically untouched.24 This means that the interproximal areas are at a higher risk of developing periodontal lesions and caries as well as plaque accumulation which is one of the primary etiological factors of periodontitis.23 The average patient without braces removes less than half of the plaque when brushing alone one time per day leaving about 60% of the plaque in their mouth, promoting rapid regrowth.16 Therefore, if an average of 60% of the plaque is left after brushing, it is reasonable to assume that flossing might reduce the plaque in the interproximal areas. In a systematic review of studies assessing the effect of both flossing and tooth brushing as compared to tooth brushing alone on plaque and gingivitis with 11 of 1353 studies meeting the inclusion criteria, a majority of the studies did not demonstrate a benefit for flossing on plaque or clinical parameters of gingivitis. Based on a metaanalysis on plaque index and gingival index, it should be determined on a per patient

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basis if high-quality flossing is achievable. It was concluded that routine instructions to floss are not actually supported by scientific evidence.25 In a study of adults in the Detroit area, the average adult reports brushing their teeth two times a day, and close to one third of the population report flossing at least once per day.26 However, in a similar survey of adults in Sweden, only 12% reported daily flossing.27 So, in the non-orthodontic population, at best 50% but at worst perhaps even fewer than 12% of patients typically floss daily, based on the flossing habits of subjects who do not have to deal with the added encumbrance of having to floss around braces. Although I could not find any published study that demonstrates the flossing frequency of patients in braces, it would be reasonable to assume that this frequency is very low.

What are the Effects of Interdental Cleaning on Gingival Health? A study was conducted by Nanning et al in non-orthodontic patients comparing standard oral hygiene with flossing to standard oral hygiene with the use of a standard oral irrigator or an oral irrigator with a prototype tip. With respect to Bleeding Index (BI), it was observed that both oral irrigator tips had significantly greater reduction in BI than flossing. In fact, there was no statistical change in BI while flossing. There was also no statistical difference between any of the methods with regard to Plaque Index (PI). These results indicate that effective use of an oral irrigator can reduce bleeding on probing over flossing, but an oral irrigator has no effect on PI.28 In a similar study by Barnes and colleagues comparing toothbrushing and flossing to toothbrushing and the dental water jet as well as use of a sonic toothbrush combined with using the dental water jet, it was found that groups with oral irrigation were

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statistically significantly more effective in reducing BI. With regard to reduction in Gingival Index (GI), groups with oral irrigation had significantly lower GI on the facial surfaces of teeth. With respect to PI, at the end of the study at day 28, only the combination of a sonic toothbrush with the oral irrigator had a significantly lower PI.29 Again, conclusions that can be drawn from these results are that in non-orthodontic patients, oral irrigation can significantly reduce BI and GI, but likely has minimal if any effect on PI. However, oral irrigation may have a very different effect on PI of orthodontic patients. Sharma and colleagues examined adolescent patients with fixed orthodontic appliances comparing PI and BI when using manual toothbrushing combined with the daily use of 1) a dental water jet (DWJ) with a specialized orthodontic tip, 2) flossing once/day, or 3) manual toothbrushing alone. They recorded PI and BI for the whole mouth and interproximally at baseline, 2 weeks, and 4 weeks. The PI decreased in all three groups at two and four weeks, but significantly with Group1 > Group 2 > Group 3. In fact, the DWJ group had 3.76 times the reduction in PI as the flossing group and 5.83 times the reduction in PI as the toothbrushing alone group. For BI, all three groups again showed a significant reduction in whole mouth bleeding with the same comparative order of Group 1 > Group 2 > Group 3, with Group 1 having 26% reduced whole mouth bleeding over Group 2. However, for interproximal bleeding, all 3 groups were the same at the end of 4 weeks.30 This study showed that the adjunctive oral hygiene aid of a DWJ has a very significant effect on PI in orthodontic patients whereas in non-orthodontic patients use of a DWJ does not seem to make a conclusive difference. The study also showed that

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flossing combined with toothbrushing significantly decreases PI and whole mouth BI. The interesting outcome was that in orthodontic patients there was no difference between methods with regards to interproximal bleeding. In a systematic review by Berchier and colleagues to assess the combined effect of both flossing and toothbrushing compared to toothbrushing alone on plaque and gingivitis, of the eleven studies that met the inclusion criteria, the majority showed no benefit to flossing for reduction of plaque or reduction of gingivitis. It was concluded that routine use of floss to reduce plaque or gingivitis is not supported by scientific evidence.25 Three out of eleven studies showed a significant reduction in plaque removal with the adjunctive use of dental floss. However, none of the eight studies that examined gingival inflammation showed a significant effect of dental floss as a supplement to toothbrushing. Only one of four studies found a significant difference in a reduction in BI from the adjunctive use of floss with toothbrushing. However, in a 21-day study by Barendregt and colleagues on non-brushers, the floss group had a 31-34% reduction in BI compared to the group that did not use any other form of oral hygiene.31 In a study of the effects of flossing, Hujoel and colleagues found that professional flossing performed only during school days predominantly on primary teeth in children with a low fluoride exposure resulted in a 40% reduction in the rate of caries. However, self-performed flossing in young adolescents for two years did not result in a decrease in caries. So, professional flossing in children is highly effective in reducing interproximal caries risk in a low fluoride exposed sample, but self-flossing has not been demonstrated

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to result in any decrease in caries rates in the presence of topical fluorides. Topical fluoride application may diminish or eliminate the benefits of flossing.32 In his review, he was unable to identify even two independent randomized clinical trials that can demonstrate that self-performed flossing reduces caries risk. Therefore, although thorough flossing by a professional nearly five days a week can reduce the risk of caries, it does not appear that self-flossing is done to the same standard or perhaps frequency (for example, passing floss through a contact is far less efficacious than wrapping floss around each tooth) and may have very little clinical benefit with respect to caries. In a study comparing the use of interdental brushes to dental floss for moderate to severe periodontitis patients, it was found that when combined with the use of a manual toothbrush, using interdental brushes results in a slightly greater removal of plaque and larger decrease of probing depth than using dental floss. When accounting for patients’ preference for interdental brushes over dental floss, interdental brushes are preferable to flossing for interdental plaque reductions in moderate to severe periodontitis patients.33

How Does Orthodontic Treatment Affect Plaque and Gingival Health? “The banding and bonding of orthodontic appliances to teeth increases the number of plaque retention sites and, as a result, oral hygiene becomes more difficult” 34 Gwinnett and Ceen showed that with fixed orthodontic appliances, both the bracket and the bonding resin attract and collect bacteria even in patients with good oral hygiene. In addition, the resin is usually covered with microorganisms, even though this is easily cleaned. Any resin ledges provide ideal sites for plaque growth. The study’s authors

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state: “There can be no doubt that bracket configuration and the presence of wires, elastics, springs, and other attachments interfere with the patient’s ability to keep some portions of the teeth and brackets clean.”35 Chatterjee and Kleinberg showed that regardless of the area of the mouth examined, the plaque pH, Ca, and P levels decreased after placement of orthodontic appliances, and the carbohydrate levels rose. The greatest lowering of levels of the pH, Ca, and P was in the maxillary incisors along with the greatest rise in carbohydrate levels. The lower levels of Ca and P would also decrease the ability of the enamel to remineralize in an acidic attack.36 As previously noted, the maxillary incisors are also the teeth most commonly affected with white spot lesions. Scheie, Arneberg, and Krogstad found that three months after teeth were banded, S. mutans levels increased in saliva and on the banded surfaces of teeth. It was concluded that making new retention sites promoted local growth of S. mutans and in turn led to a generalized increase in the levels of S. mutans.37 However, Hausen and Fejerskov (1994) found even though higher plaque levels of S. mutans and lactobacilli may indicate a greater caries risk, using bacterial counts to predict caries development is not certain and has minor clinical significance.38 B. Zachrisson and S. Zachrisson found that there was certainly a correlation between oral health while in braces and caries incidence. As the average PI and GI scores increased, there was almost a linear increase in the average Caries Index scores. Girls tended to have a lower PI, GI, and Caries Index than boys.39 Sukontapatipark and colleagues found that excess composite around the base of brackets is the critical site for the accumulation of plaque because of its rough surface

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and a distinct gap at the enamel-composite interface, leading to mature plaque on excess composite two to three weeks after bonding.40 In the seminal study on the effects on the gingiva, before, during, and after fixed orthodontic treatment, B. Zachrisson and S. Zachrisson concluded the following: In spite of good cleaning with low PI scores, most children developed generalized moderate hyperplastic gingivitis within one to two months after the placement of the appliances. These changes persisted throughout the period of active treatment with slight increase at subsequent appointments. Severe gingivitis was noted only in exceptional cases of patients with poor oral hygiene. Even patients with perfect tooth cleaning developed mild inflammatory changes. The interproximal areas were constantly more affected than the buccal areas and posterior teeth more than anterior teeth. The main improvements in gingival health occurred during the first month after band removal. The reduction in pocket depths after treatment was due mainly to shrinkage of hyperplastic gingivae. Hence the gingival changes were transient and no permanent damage to the periodontal tissues could be demonstrated with the methods used.41 These results indicate that regardless of a patient’s Oral Hygiene (OH), there will be a tendency for gingivitis and hyperplastic gingiva to develop. However, the periodontal changes during fixed orthodontic treatment are largely transient with no long term detrimental effects. So, efforts to improve or maintain exceptional OH during treatment might prevent gingivitis and hyperplastic gingiva from developing. This can be beneficial for bracket repositioning/placement during treatment as well as for reducing gingiva that might trap plaque (making the difficulties of maintaining good OH during treatment even more difficult and thereby increasing the tendency to develop WSLs). In some orthodontically treated individuals, there can be a severe reaction of true gingival hyperplasia in spite of good OH. In one such case, the tissue nearly grew over the brackets but receded back to normal within a few months of removing the brackets.42

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This is further demonstration that fixed orthodontic appliances can alter the oral environment to induce gingival changes without excess plaque accumulation. In a histologic examination of tissue biopsies from first molars, B. Zachrisson found that although there were slight numbers of inflammatory cells before treatment, during treatment, there were always “increased mononuclear cell infiltrates, hyperplasia and proliferation of the pocket epithelium.” During treatment, most cases displayed dense accumulations of chronic inflammatory cells occupying large portions of the pocket area of the connective tissue. However, after the removal of appliances, the cellular and vascular changes decreased and the tissue gradually returned toward normal conditions.43 In a study based on the same sample population of orthodontically treated and untreated individuals, B. Zachrisson and Alnaes examined loss of attachment, gingival pocket depth, and clinical crown height. The study showed that orthodontic patients had a significant and slightly greater amount of loss of attachment with a mean loss of attachment of 0.41mm compared to 0.11mm for a difference of 0.3mm greater attachment loss for orthodontically treated individuals. However, the average pocket depth and crown height were nearly the same in the two groups.44 In seeming direct contrast to the results of the previous study, Zachrisson and Alstad performed a similar longitudinal study on the periodontal condition of orthodontic patients and in that group compared with their untreated control, patients exhibited good to excellent oral hygiene during treatment with statistically lower plaque index and gingivitis scores at the last record four to five months after debonding. They found no statistically significant differences in attachment loss with an average loss of attachment

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at each surface of less than 0.1mm. They attributed the differences in the results of the two studies to less aggressive oral hygiene methods in the second study.45 With respect to alveolar bone loss, B. Zachrisson and Alnaes found that orthodontic patients had significantly greater loss of alveolar bone based on bitewing xrays exhibiting an average of 1.11mm alveolar bone loss in the treated group compared to 0.88mm in the untreated group (difference of 0.23mm bone loss) with the greatest amount of bone loss adjacent to extraction spaces on the pressure side. However, there was considerable individual variation with some patients displaying significantly more than the average.46

Patient Oral Hygiene Compliance With so much variation in patients’ oral hygiene compliance, one might ask, “What are the negative effects when an orthodontic patient does not have good oral hygiene compliance? How well does that average orthodontic patient comply with prescribed treatment, and how can patients be positively motivated?” The following are some studies that answer the first question. A post-hoc analysis was performed by Maaitah and colleagues of patients recruited for a randomized controlled trial, accessing demineralization at debonding by using quantitative light-induced fluorescence to determine predictors for the presence and degree of demineralization during orthodontic treatment. It was found that “sex, pretreatment age, oral hygiene, and clinical status of the first molars can be used as predictors for the development and severity of white spot lesions during orthodontic treatment.”

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In the study, 28.3% had no WSLs, 71.7% had 1-12 WSLs with the average patient with demineralization having 2.9 WSLs. Patients with demineralization tended to be younger and to have carious first molars.47 Because hygiene compliance can be problematic for orthodontic patients, it may also be necessary to critically evaluate even the bonding method of placing brackets in an effort to minimize enamel decalcification during treatment. It was noted by Ghiz and colleagues that although a self-etching primer might save chair time and be more costeffective, this method provides less resistance to enamel decalcification than a conventional etch and sealant, in particularly in patients with poor oral hygiene.48 In a recent study in Norway by Hadler-Olsen and colleagues investigating the incidence of caries and white spot lesions in orthodontic patients with a comprehensive oral hygiene regimen, it was ascertained that the WSL index in orthodontic patients is 1.9 compared to 0.4 in the control group. Only 23% of treated patients showed good compliance whereas 68% showed moderate compliance, and 9% had poor compliance with a mean increase in WSLs of 1.0, 1.4, and 3.3 in the respective groups. Therefore, orthodontics patients have a significantly higher risk for developing WSLs compared to untreated patients. However, there was no difference in the rate of caries for treated and untreated groups.49 According to Todd and colleagues for orthodontic patients with poor OH, many different fluoride regimens have been used to reduce demineralization. It has been shown in an in vitro study that teeth treated with Duraflor fluoride varnish exhibited 50% less demineralization than control teeth and even greater difference in demineralization when

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controlled to a placebo group. Therefore, fluoride varnish should be considered as an adjunct oral hygiene aid for orthodontic patients with poor oral hygiene.50 From these studies, it is clear that one of the most challenging aspects of being an orthodontist is educating and motivating patients to practice routine, effective oral hygiene, or the patients will be left at best with WSLs that likely may never fully remineralize, and at worst with fully cavitated lesions that could require extensive restorative procedures.

What Methods Can an Orthodontist Employ to Increase Motivation, Oral Hygiene, and Compliance in Orthodontic Patients? What Role Does the Device Play in Compliance? There are many strategies that can be undertaken in an office to improve the oral hygiene of orthodontic patients. One such method reported by Lalie and colleagues was to provide the patient with a personalized counseling session on oral hygiene in addition to providing traditional oral health education (i.e., verbal instructions and a demonstration of proper brushing technique on a typodont, or oral model). When personal OH counseling was done, patients accomplished significant improvement in oral hygiene: not only was the PI significantly lowered after six months, but the prevalence of gingival inflammation remained significantly lower compared to only providing traditional oral hygiene instructions.51 In another study by Al-Jewair, Suri, and Tompson evaluating three different motivational techniques for oral hygiene and their effect on gingival health, patients who

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were motivated by being shown live bacteria from their own mouth in a microscope in addition to conventional plaque disclosing measures accompanied by a demonstration of the horizontal scrubbing method of brushing had a statistically significant decline in average gingival scores over six months. This method reduced the need for frequent reinforcement at appointments when compared to traditional chair side motivational exams and plaque control measures.52 In a study examining predictors of adolescent compliance with oral hygiene instructions, it was ascertained that adolescent patients whose parents were married and also patients with good academic performance were more likely to comply with oral hygiene instructions given at the start of treatment.53 Varying factors that affect compliance during orthodontic treatment have been examined by Trakyali and colleagues ranging from poor relationship of the patient with the family, anxiety of the child related to familial attitude, socioeconomic factors, the influence of parents’ attitude and perception of dental esthetics, self-perception of the child, as well as parents’ extremely tolerant attitude. It was found that the mother’s attitude toward her children did not affect the child’s compliance. However, the father’s attitude did play a significant role on patient compliance and lowered the state of anxiety of the patient when he was caring and a problem solver. It was recommended to reduce the child’s anxiety through education and relaxation techniques as well as through having the father present at the first appointment during child education.54 In addition, it has been shown by Levin that an award/reward system may help motivate below average compliers. In an award/reward system, patients received compliance instructions and a written evaluation of compliance or compliance

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instructions, a report card, and ability to get rewards for good behavior. Above average compliers retained above average compliance. Academic performance was also correlated with compliance.55 From a practice management point of view, maintaining good home care during orthodontic treatment can result in less chair side time, shorter visits, greater patient flow efficiencies, and a better smile with healthier gums as well as greater case closing rate if concern for the patient’s overall oral health can be demonstrated by the orthodontic provider.56 Based on a survey of 118 items sent to orthodontists throughout the U.S. with 429 responses, the following factors were ranked as motivating patients to comply: desire for treatment, relationship with parents, verbal praise and communication, high self-esteem, obedient, accommodating, self-confident, patients’ perception of their malocclusion. Useful ways to improve compliance therefore include establishing good doctor-patient rapport and verbal praise.57 According to White, patients can be motivated in many different ways. Based on standard perception of behavior, there are three broad categories of behavior modification: positive reinforcement, negative reinforcement, and punishment. Punishment should only be used to extinguish behavior; positive reinforcement should be used to increase patient compliance; and negatives such as pain, fear, frustration and humiliation should be limited. When using these standard methods to modify behavior, consequences for behaviors should be delivered immediately in order to connect the behavior and the consequence. Patients with low pain tolerance and heightened sensitivity are often non-

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compliant and therapies need to be designed so they can cooperate. Poorly compliant patients often become trapped in a vicious reinforcing cycle of inflammation, neglect, and plaque accumulation. Aggressive strategies may be needed for these patients such as a prophylaxis, chlorhexidine, and antibiotics. When child patients are negligent regarding oral hygiene, the parents need to be shown the poor hygiene at every appointment. Patients with good oral hygiene tend to be good compliers. However, patients who are poorly compliant with oral hygiene tend to be poorly compliant in every other aspect of treatment. Oral hygiene is often the cornerstone of treatment.58 In an effort to motivate patients, others have shifted the focus of compliance from that of a reactive, often adversarial system to one that utilizes the concepts of recognition (or acknowledgement) and empowerment through the use of a patient contract. Through this method, the patient is made a full partner in the treatment, and patient cooperation is often significantly increased. This method also separates the responsibility of the patient from that of the orthodontist.59-61 Gold also stresses the importance of a contract with the patient, which leads the patient to accept responsibility for cooperation. In addition, Gold stresses development of a mutual, trusting relationship by being non-authoritarian and reinforcing the patient’s self-esteem so that recognition and acceptance acts as an encouragement toward compliance with the patient. He stresses plaque-control counseling sessions and selfdisclosure with emotional honesty, utilizing gestalt psychology (focusing on the what and how of behavior) along with Rogerian psychology (interviewing with active listening while withholding judgment or evaluating, and concentrating on feelings).61

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In a similar manner, Clark also emphasizes the importance of showing respect for the patients and treating them as equals, recognizing and respecting their inner capabilities to achieve excellent oral health. According to Clark, every patient should be given the tools to perform proper oral hygiene and tested over many weeks with a comment at every appointment and praise for healthy, well-maintained mouths. He also advocates showing patients bacteria from their mouths under a microscope and sharing the responsibility for oral health with the parents. When oral hygiene is poor, the patient must be engaged in an open dialogue. The patient’s potential for excellent oral health must be recognized; with this, respect and ability to motivate will increase.62 In a Randomized Controlled Trial (RCT) of accessing oral hygiene by patients, parents, and orthodontists based on a six point scale, it was determined that both patients’ and parents’ evaluations of the patient’s oral hygiene were significantly higher than the orthodontists’ assessment; also, the patient’s age, sex, or school performance were related to the orthodontist’ oral hygiene ratings. In addition, feedback over seven visits did not appear to improve compliance. This supports the Health Belief and Health Decision Models where patients and parents may not view dental disease as serious in relation to general health or appreciate the future time and monetary consequences of future dental disease.63 The finding that compliance of the patient is not sex dependent is in direct contrast to the findings of Cucalon and Smith who reported that 63% of their “good compliance group” were females. In addition, they found that more compliant patients had higher self-esteem, derived self-satisfaction from personal achievement, were

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optimistic about the future, and were from higher socioeconomic demographics as well as possessed a low degree of general alienation from society.64 Just because a patient is not compliant with one aspect of their treatment does not necessarily mean they will be non-compliant with all aspects of their treatment. Patient noncompliance should be viewed as a discrete behavior problem instead of a general style of behavior.65 Similarly, El-Mangoury supported that orthodontic cooperation is predictable through psychological testing, with high-need achievers cooperating better with orthodontics than low-need achievers. High-need affiliators (those who seek to maintain or restore close interpersonal relations) cooperate better orthodontically than low-need affiliators, and internals cooperate better than externals. Orthodontic cooperation does not have a simple dimension of cooperation. It is composed of two constructs, one that is focused on only orthodontic cooperation and one that is a combination, or perioorthodontic, cooperation. This means a patient who practices good oral hygiene will not necessarily show consistent compliance with wearing headgear.66

Is There a Proper Way to Measure Plaque in Orthodontic Patients and How Do Plaque Levels Change throughout Treatment? Does Hygiene During Orthodontic Treatment Affect Long-term Oral Hygiene Habits? When accessing oral hygiene and plaque index in orthodontic patients, often plaque indexes are modified or may not capture the full spectrum of hygiene because plaque indexes were developed for smooth surfaces of teeth. Yet, in orthodontic patients,

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plaque is often focused around the bracket. The Orthodontic Plaque Index (OPI) was developed to access oral hygiene in addition to the caries and gingivitis risk of patients. The OPI divides the mouth into sextants and assigns a score for each sextant that is based on plaque around the bracket and on inflammation of the gingiva. The OPI was designed for a visual inspection for daily use in orthodontic practices. However, to date this method has not yet garnered widespread acceptance in practices or research.67 In a similar manner, Klukowska and colleagues describes a method for accurately measuring plaque levels in orthodontic patients by using a fluorescing plaque stain and then using a computer to automatically determine the amount of plaque based on UV photography. Because of the specialized equipment involved, this method is only well suited for research. The average plaque scores for orthodontic patients measured using this method was 41.9% +-18.8%. Using this method, it was shown that plaque accumulation in orthodontic patients is extremely high, being two to three times higher than observed in high plaque-forming adults without appliances.68 A long-term study encompassing ten years following orthodontic treatment found that there were no significant periodontal differences between those who had and those who had not had orthodontic treatment. Therefore, it was concluded that orthodontic treatment when a patient was young had no detectible difference on later periodontal health.69 One possible conclusion from these results is that there are no long-term deleterious periodontal effects from orthodontic treatment. However, an alternate

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conclusion could be that the focus on oral hygiene exercised during active treatment is not carried on later in life after treatment is completed. Monitoring the oral hygiene habits of new and experienced orthodontic patients who had been assigned into a behavioral self-management group or into an instructionsplus–persuasion group resulted in significant improvement in oral hygiene for both groups and was maintained for five months after the program was started. These results demonstrated two results: 1) that rinsing and brushing regimens can be strengthened by providing patients with oral hygiene products and requiring them to bring back these items to each visit, and 2) that monitoring the oral hygiene habits of the patients changes the habits themselves.70 . In a study assessing plaque control and gingival inflammation during orthodontic treatment, plaque scores remained nearly constant before and during treatment except around lower fixed appliances, where there was a marked decline in plaque control followed by a gradual improvement. However, levels of gingival inflammation are consistently worse during treatment.71 The underlying question would be whether many of the controlled studies on oral hygiene compliance and its effects are actually representative of real life practices. The value of attaining good oral hygiene was assessed when 50 patients who had to attain a plaque score of less than 10% was compared to 50 patients who did not have formal dental health education. The group who had to achieve a 10% plaque score before treatment had only one patient discontinue treatment compared to five in the control group. Also, within the low initial plaque scoring group, there were no missed appointments in the first six months compared to 17 missed appointments in the control

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group. Therefore, having to achieve and maintain good oral hygiene may be a benchmark for maintaining compliance in all aspects of treatment.72 For orthodontic patients who are not in a structured plaque control program, plaque and gingivitis scores progressively increased over the initial 10 months of treatment. Patients who received plaque control instructions with monthly reinforcement along with use of a light fluorescing disclosant, Plaklite, showed a slight improvement in plaque and gingival index scores over 10 months.73

Hawthorne Effect Review of all these various studies gives rise to an underlying question: Does a patient’s knowledge that he/she is participating in a study that measures a certain behavior, inherently change the frequency or manner in which the behavior is performed? In many studies on human subjects, it is assumed that when there is an unexplained result from an experiment, the result took place because of the participants’ awareness of the experiment; due to their awareness, they may have acted in a different manner than they otherwise would have. This altered behavior could easily yield statistically significant improvements in a control group as compared to baseline. Gains made by the placebo control groups when none were expected have been termed the “Hawthorne effect.” It has been shown that orthodontic patients who were intentionally deceived into believing that they were participating in a clinical trial of a new toothpaste had a statistically significant improvement in oral hygiene that lasted as long as six months. Therefore, when used intentionally, the Hawthorne effect can improve oral hygiene compliance in orthodontic patients.74

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In other words, the mere participation of subjects in a study can alter behavior. For instance, when patients are instructed to brush and floss in a certain manner for a study, even though they were instructed in almost the exact same manner at the beginning of treatment with little results, these patients will likely perform differently, i.e. demonstrate more consistent compliance, for the study. Applying these behavioral considerations to oral hygiene in orthodontics raises this question, “Is comparing the efficacy of flossing to using any other interproximal cleaning aid such as the AirFloss actually performed in real life—that is, will the average patient actually floss on a daily basis?” Perhaps the more pertinent question is, “How compliant will the patient be in using a particular interproximal cleaning device during orthodontic treatment?” From my clinical observation, patients tend to be lazy and will do the minimum required to get through treatment. Extrapolating from this assessment, one might conclude that the best form of oral hygiene aid would be the one that demands the least amount of time and effort to complete the given task.

Can Oral Hygiene Compliance During Treatment be Reflective of Compliance with Other Prescribed Tasks During Treatment as well as Overall Treatment Time? In a retrospective study of 366 consecutively treated cases, poor oral hygiene was one of nine significant variables that accounted for 38% of the variation in treatment time. Three or more poor oral hygiene notations coincided with an average 2.2 additional months of treatment. Other significant variables were male sex, maxillary crowding of 3 mm or greater, Class II molar relationships, proposed treatment plans involving extractions, delayed extractions, poor elastic wear, bracket breakages, and repositioned

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brackets.75 These results illustrate that poor oral hygiene can and does significantly affect treatment time and may be covariant with other forms of poor compliance. Similarly, in an evaluation of 31 variables from 144 consecutively treated cases, over half of the variation in treatment time could be explained by six variables: missed appointments, loose brackets and bands, poor oral hygiene, more than one phase of treatment, headgear wear, and between office differences. Every poor hygiene notation coincided with an average added two-thirds of a month of treatment time.76 As demonstrated by these two studies, oral hygiene compliance can be reflective of compliance in other aspects of treatment. However, the reverse conclusion cannot be drawn, i.e., that if oral hygiene compliance were improved, compliance in other areas of treatment would improve as well.

Evaluation of a New Interproximal Cleaning Device Based on the previously cited studies, there is compelling research to support the need for good oral hygiene during fixed orthodontic treatment. However, the specific role of interproximal cleaning on overall oral health is open to further review. Nonetheless, it is reasonable to postulate that any device or method that is easier to use and requires less time to perform the given function will be adhered to with more frequency; identifying such devices or methods is the logical next step. One device fitting these criteria, the Philips Sonicare AirFloss, may offer increased patient preference and compliance over string floss for interproximal cleaning during orthodontic treatment. Accordingly, an evaluation of the current literature of the AirFloss is in order. To date, seven studies have been performed that evaluate the AirFloss, two of which have

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been published in peer-reviewed journals. The remaining five studies were performed inhouse by Phillips Sonicare. There is one additional unpublished study on the AirFloss. The studies from Phillips Sonicare cover the following topics: Plaque Biofilm Disruption, Gingivitis Reduction and Plaque Removal, Compliance, Safety, and Patient Preference. The AirFloss was developed in an effort to address these issues. The primary objective of any teeth-cleaning is obviously to be effective in plaque disruption and removal. An in vitro study was performed to evaluate the removal of interproximal plaque biofilm. When using the Philips Sonicare FlexCare along with the AirFloss, the FlexCare alone removed 31% of the interproximal plaque whereas both the AirFloss and FlexCare together removed 51.6% of the interproximal biofilm. Based on this study, the Sonicare AirFloss removed 66% more plaque biofilm from interproximal surfaces than the Sonicare FlexCare alone.77 A study evaluating gingivitis reduction and plaque removal comparing the use of manual toothbrushing twice a day to manual toothbrushing twice a day combined with use of the AirFloss once a day, obtained the following results: Sonicare AirFloss, when used in addition to a manual toothbrush, provided significantly greater reductions in gingivitis and bleeding sites (p