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Research Article
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Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study TERDPHONG TRIRATANA, DDS, PETCHARAT KRAIVAPHAN, DDS, CHOLTICHA AMORNCHAT, DDS, LUIS R. MATEO, MA, BOYCE M. MORRISON, JR., PHD, SERGE DIBART, DMD & YUN-PO ZHANG, PHD, DDS (HON) ABSTRACT: Purpose: To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. Methods: 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. Results: After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful. (Am J Dent 2015;28:68-74). CLINICAL SIGNIFICANCE: The results of this double blind clinical study supported the conclusion that brushing twice daily with a triclosan/copolymer/fluoride dentifrice can help promote oral health by reducing plaque and gingivitis, whereas the herbal/bicarbonate dentifrice was no more effective than the fluoride dentifrice.
: Dr. Yun-Po Zhang, Colgate-Palmolive, 909 River Road, Piscataway, NJ 08854, USA. E- :
[email protected]
Introduction The oral cavity supports one of the densest and varied indigenous flora, and the emphasis, over all these years, has been to assess how this flora can overgrow and cause dental diseases.1 This flora does not represent a homogeneous collection of organisms throughout the oral cavity, but rather it is localized in three main foci: on the dorsum of the tongue, in the gingival crevice, and on those areas of the teeth not cleaned by mastication.2 The latter are located below the coronal third of the tooth and are areas of plaque accumulation and retention. When not removed regularly by the patient, gingival inflammation sets in3 with the development of gingivitis, periodontitis, or the initiation of dental decay.4 Periodontal disease and dental caries are highly prevalent oral diseases that can lead to pain and discomfort, oral hygiene and esthetic problems, and eventually tooth loss, all of which can be costly to treat and are a burden to healthcare systems. Daily care of the mouth by the patient is the most important phase of preventive periodontics. Techniques for keeping the mouth clean have been discussed at length in the literature.5 Basically, the patient has to follow the oral hygiene practices prescribed by the dentist or the dental hygienist. Since the objective of the patient’s role in prevention of periodontal disease is to keep the teeth and gingiva free of the established plaque, the patient should make use of all aids readily available. Among the aids to oral health care are toothbrushes, toothpastes, floss, interdental stimulators and dental irrigators. Tooth brushing has the potential to achieve gingival and periodontal health through the mechanical removal of plaque.5 This ability can be enhanced significantly by the use of an
appropriate dentifrice. Toothpastes have the potential to provide additional or adjunctive oral care benefits through chemical and physical means. Over recent decades, toothpaste formulations have been manipulated to deliver chemical and physical mediated benefits ranging from the prevention of caries and supragingival plaque and calculus, to the removal of stains and the relief of dentin hypersensitivity.6 Triclosan is an antibacterial agent which, along with a copolymer for aiding retention, can be added to toothpastes to reduce plaque and gingivitis.7 This single-center, double-blind, parallel-group, three-cell, randomized clinical study investigated the clinical efficacy of triclosan/copolymer/fluoride dentifrice as compared to an herbal/bicarbonate dentifrice and to a fluoride dentifrice in controlling established gingivitis and dental plaque over 6 months.
Materials and Methods This clinical study was conducted in Bangkok, Thailand. Prior to initiation of the study, the protocol and pertinent documents were reviewed and approved by the Mahidol University Institutional Review Board (IRB approval #:MUDT/PY-IRB 2012/046.1409). Male and female subjects who signed an informed consent form were selected based on the following inclusion and exclusion criteria. Inclusion criteria: 1. Subjects had to be between the ages of 18 and 70 (inclusive), and in generally good health. 2. Subjects were required to be available for the 6-month duration of the study. 3. Subjects had to possess at least 20 uncrowned permanent natural teeth (excluding third molars).
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4. Subjects with a mean Gingival Index score of at least 1.0 determined by the Löe-Silness Gingival Index and a mean Plaque Index score of at least 1.5 determined by the Turesky modification of the Quigley-Hein Plaque Index were enrolled in the study.
Exclusion criteria: 1. Subjects were excluded from the study if they had advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone), five or more decayed carious lesions requiring immediate restorative treatment, or tumor(s) of the soft or hard oral tissues of the oral cavity, or presence of partial removable dentures or presence of orthodontic bands. 2. Subjects were excluded from the study if they were on any prescribed medications that could interfere with the study outcome or used antibiotics within 1 month prior to the start of the study or if they started taking them during the course of the study or received a dental prophylaxis in the 2 weeks prior to the baseline examination. 3. Pregnant or lactating women, individuals who were participating in any other clinical study or who had participated in a study or test panel within 1 month prior to enrollment of study, or individuals with a history of alcohol or drug abuse were not allowed to participate in the study. 4. Subjects with a history of allergies to the test products, or allergies to oral care/personal care consumer products or their ingredients, or subjects with existing medical conditions which prohibits them from eating and drinking for periods up to 4 hours were also excluded from the study.
Qualifying subjects received a baseline gingivitis and plaque evaluation, along with an oral soft and hard tissue assessment. They were randomly assigned to one of the three study treatments using a randomization table generated centrally by the study statistician. The three treatments employed in this study were identified as follows: • Triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base (Colgate Totala toothpaste). • Herbal/bicarbonate dentifrice containing a mixture of herbs and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base (Parodontaxb toothpaste). • Fluoride dentifrice containing 450 ppm F as sodium fluoride and 1,000 ppm F as sodium monofluorophosphate (Colgate Cavity Protectiona toothpaste). Following randomized treatment assignment, subjects were provided with a soft-bristle toothbrush and a tube of toothpaste for home use. All toothpastes were overwrapped in their original package to maintain the double-blind to subjects and the examiner. One study coordinator, who was not involved in examinations, was assigned to dispense the test products in a separate room. Subjects were instructed to brush their teeth for 1 minute twice daily (morning and evening) with the toothpaste provided. Subjects were instructed to only use the treatment products assigned to them during the study. Subjects were not restricted regarding diet or smoking habits during the course of the study. The sample size of 43 subjects per group was estimated, based on previous investigations conducted in the population, using the following assumptions: (1) a 6-month study period, (2) three treatment groups, (3) mean SD among three groups
Toothpaste plaque & gingivitis control 69
= 0.28, (4) power = 0.8, (5) = 0.05, ANOVA, (6) a 20% difference between products, (7) 10% drop-out rate over the study. Subjects returned to the clinical facility for gingivitis and plaque examinations after 3 weeks, 3 months and 6 months of product use. Additionally, at each examination subjects received an evaluation of their oral soft tissue by the examining dentist and were questioned for the occurrence of any adverse events. At the end of the study, subjects returned all test products, which were visually assessed by the coordinator for subject compliance. Clinical scoring procedures - Subjectwise scores were calculated by summing all scores for all sites and dividing by the total number of sites scored. This calculation was performed separately for gingivitis and for plaque. A single examiner who has over 25 years’ experience in clinical dental research as a principal investigator and examiner for numerous plaque and gingivitis clinical studies was used for this study. Oral soft and hard tissue assessment - The visual examination included an evaluation of the soft and hard palate, gingival mucosa, buccal mucosa, mucogingival fold areas, tongue, sublingual and submandibular areas, salivary glands, tonsilar and pharyngeal areas, and the teeth. Gingivitis assessment - The degree of gingival inflammation was scored at six sites (disto-, mid-, mesio-buccal and disto-, mid-, mesio-lingual) of each tooth according to the criteria of the Gingival Index system.8 0 = Absence of inflammation. 1 = Mild inflammation – slight change in color and little change in texture. 2 = Moderate inflammation – moderate glazing, redness, edema and hypertrophy. 3 = Severe inflammation – marked redness and hypertrophy. Tendency for spontaneous bleeding.
Dental plaque assessment - The dentition was disclosed with disclosing solution and plaque scored at the disto-, mid-, mesio-buccal and disto-, mid-, mesio-lingual surfaces of each tooth according to the criteria of the modified Quigley and Hein Index:9,10 0 = No plaque. 1 = Separate flecks of plaque at the cervical margin. 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin. 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth. 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.
Adverse events - Adverse events were obtained from an interview with the subject and from a dental examination by the examiner. Statistical methods - Statistical analyses were performed separately for the gingivitis and dental plaque assessments. Comparison of the treatment groups with respect to gender was performed using a Chi-Square analysis and to age using an ANOVA. Comparisons of the treatment groups with re-
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70 Triratana et al
Consent requested for 169 eligible subjects aged 18-70 years 11 did not consent Consent acquired from 158 volunteers
13 subjects unavailable for exam 10 subjects did not meet inclusion criteria: 4 - gingival index scores below 1.0; 6 - did not have 20 uncrowned permanent natural teeth.
135 subjects had baseline examinations and were randomly assigned to products
Triclosan/Copolymer/Fluoride dentifrice
Baseline
Fluoride dentifrice
Herbal/Bicarbonate dentifrice
45 (F:22, M:23)
45 (F:23, M:22)
45 (F:24, M:21)
Mean age:
38.6 (+ 8.19)
38.4(+ 10.81)
38.6 (+ 8.18)
3 weeks 3 months 6 months
45 (0 lost) 45 (0 lost) 45 (0 lost)
45 (0 lost) 45 (0 lost) 45 (0 lost)
45 (0 lost) 45 (0 lost) 45 (0 lost)
Figure. Distribution of subjects in the 6-month plaque and gingivitis clinical study. Table 1. Subject mean (SD) Gingival Index and Plaque Index Scores at Baseline, 3 weeks, 3 months and 6 months summary for subjects who completed the 6month clinical study. _______________________________________________________________________________________________________________________________________________________________________________________________________________
Parameter
Treatment group
N
Baseline (Mean ± S.D.)
3-week (Mean ± S.D.)
3-month (Mean ± S.D.)
6-month (Mean ± S.D.)
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Gingival Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
1.78 ± 0.20 1.77 ± 0.20 1.77 ± 0.15
1.65 ± 0.23 1.67 ± 0.21 1.76 ± 0.17
1.27 ± 0.32 1.67 ± 0.34 1.63 ± 0.32
0.95 ± 0.26 1.47 ± 0.30 1.57 ± 0.28
Plaque Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
3.55 ± 0.36 3.56 ± 0.36 3.53 ± 0.37
2.98 ± 0.37 3.50 ± 0.25 3.46 ± 0.15
2.45 ± 0.29 3.45 ± 0.42 3.31 ± 0.42
1.65 ± 0.45 3.23 ± 0.35 3.40 ± 0.39
_______________________________________________________________________________________________________________________________________________________________________________________________________________
1 2 3 4
0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride. A mixture of herbs and 1,400 ppm F as sodium fluoride. 450 ppm F as sodium fluoride and 1,000 ppm F as sodium monofluorophosphate. No statistically significant difference was indicated among the three treatment groups at baseline with respect to gingival index or plaque index scores.
spect to baseline gingival index scores and plaque index scores were performed using ANOVA. Within-treatment comparisons of the baseline versus follow-up gingival and plaque index scores were performed using paired t-tests. Comparisons of the treatment groups with respect to baselineadjusted gingival and plaque index scores at the follow-up examinations were performed using analyses of covariance (ANCOVA). Post-ANCOVA pair-wise comparisons of the study treatments were performed using the Tukey’s test for multiple comparisons. All statistical tests of hypotheses were two-sided, and employed a level of significance of = 0.05.
Results A total of 169 eligible subjects were first approached to participate; 158 consented and 148 met inclusion criteria. Of these, 135 were assigned to one of the three study groups, and 13 were unavailable for examination and were excluded from
the study (Figure). All 135 subjects entered the study, complied with the protocol and completed the 6-month clinical study. Throughout the study, no adverse effects on the oral hard or soft tissues were observed by the examiner or reported by the study subjects when questioned. Baseline data - The gender and age of the study subjects who completed the study are presented in the Figure for the three study groups. The three groups did not differ significantly with respect to these characteristics. Table 1 summarizes the mean gingival index and mean plaque index score measured at all time points. No statistically significant differences were indicated among the treatment groups with respect to baseline scores. 3-WEEK DATA Table 2 summarizes the baseline-adjusted mean gingival index scores and baseline-adjusted mean plaque index scores measured after 3 weeks of product use.
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Toothpaste plaque & gingivitis control 71
Table 2. Baseline-adjusted subject mean (SE) Gingival Index and Plaque Index scores at 3 weeks for subjects who completed the 6-month clinical study. _______________________________________________________________________________________________________________________________________________________________________________________________________________
Between treatment comparison _______________________________________________________________
Within treatment analysis _______________________
Parameter
Treatment group
N
3-week (Mean ± S.D.)
% change4
Sig.5
versus herbal/bicarbonate ________________________
% diff.6
Sig.8
versus fluoride _________________________
% diff.7
Sig.8
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Gingival Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
1.65 ± 0.03 1.67 ± 0.03 1.76 ± 0.03
7.3 6.2 1.1
P< 0.001 P= 0.009 P= 0.800
1.2 -
P=0.848 -
6.3 5.1% -
P= 0.016 P= 0.066 -
Plaque Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
2.98 ± 0.04 3.50 ± 0.04 3.47 ± 0.04
16.1 1.4 2.3
P< 0.001 P= 0.361 P= 0.305
14.9 -
P< 0.001 -
14.1 -0.9 -
P< 0.001 P= 0.792
_______________________________________________________________________________________________________________________________________________________________________________________________________________
1 2 3
0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride.
A mixture of herbs and 1,400 ppm F as sodium fluoride. 450 ppm F as sodium fluoride and 1,000 ppm F as sodium monofluorophosphate.
4 Percent change exhibited by the 3-week mean relative to the baseline mean. A positive 5 Significance of paired t-test comparing the baseline and the 3-week examination. 6 7 8
value indicates a reduction in index scores at the 3-week examination.
Difference between the 3-week means expressed as a percentage of the 3-week mean for the herbal/bicarbonate group. A positive value indicates a reduction in index scores in the row heading than for the herbal/bicarbonate group. Difference between the 3-week means expressed as a percentage of the 3-week mean for the fluoride group. A positive value indicates a reduction in index scores in the row heading than for the fluoride group. Significance of ANCOVA comparison of baseline-adjusted means.
Gingival index Comparisons versus baseline - The mean 3-week gingival index scores were 1.65 for subjects assigned to the triclosan/ copolymer/fluoride group, 1.67 for subjects assigned to the herbal/bicarbonate group, and 1.76 for subjects assigned to the fluoride group. The percent changes from baseline were 7.3% for the triclosan/copolymer/fluoride group, 6.2% for the herbal/bicarbonate group, and 1.1% for the fluoride group of which the changes for the triclosan/copolymer/fluoride group and the herbal/bicarbonate group were statistically significant. Comparison between treatment groups - Relative to the subjects assigned to the herbal/bicarbonate group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a non-statistically significant reduction in gingival index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 6.3% in gingival index scores. Relative to the subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a non-statistically significant reduction in gingival index scores. Plaque Index Comparisons versus baseline - The mean 3-week plaque index scores were 2.98 for subjects assigned to the triclosan/copolymer/fluoride group, 3.50 for subjects assigned to the herbal/ bicarbonate group and 3.47 for subjects assigned to the fluoride group. The percent changes from baseline were 16.1% for the triclosan/copolymer/fluoride group, 1.4% for the herbal/bicarbonate group and 2.3% for the fluoride group, of which only the triclosan/copolymer/fluoride was statistically significant. Comparison between treatment groups - Relative to the subjects assigned to the herbal/bicarbonate group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 14.9% in plaque index scores. Relative to subjects assigned to the fluoride group,
subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 14.1% in plaque index scores. Relative to the subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a non-statistically significant increase in plaque index scores. 3-MONTH DATA Table 3 summarizes the baseline-adjusted mean gingival index scores and baseline-adjusted mean plaque index scores measured after 3 months of product use. Gingival Index Comparisons versus baseline - The mean 3-month gingival index scores were 1.27 for subjects assigned to the triclosan/ copolymer/fluoride group, 1.67 for subjects assigned to the herbal/bicarbonate group and 1.63 for subjects assigned to the fluoride group. The percent changes from baseline were 28.7% for the triclosan/copolymer/fluoride group, 6.2% for the herbal/bicarbonate group and 8.7% for the fluoride group, of which only the changes for the triclosan/copolymer/fluoride group and fluoride group were statistically significant. Comparison between treatment groups - Relative to subjects assigned to the herbal/bicarbonate group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 24.0% in gingival index. Relative to subjects assigned to the fluoride group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 22.1% in gingival index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a nonstatistically significant increase in gingival index scores. Plaque Index Comparisons versus baseline - The mean 3-month plaque index scores were 2.45 for subjects assigned to the triclosan/ copolymer/fluoride group, 3.45 for subjects assigned to the
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Table 3. Baseline-adjusted subject mean (SE) Gingival Index and Plaque Index scores at 3 months for subjects who completed the 6-month clinical study. _______________________________________________________________________________________________________________________________________________________________________________________________________________
Between treatment comparison _______________________________________________________________
Within treatment analysis _______________________
Parameter
Treatment group
N
3-month (Mean ± S.D.)
% change4
Sig.5
versus herbal/bicarbonate ________________________
% diff.6
Sig.8
versus fluoride _________________________
% diff.7
Sig.8
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Gingival Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
1.27 ± 0.05 1.67 ± 0.05 1.63 ± 0.05
28.7 6.2 8.7
P< 0.001 P= 0.074 P= 0.015
24.0 -
P< 0.001 -
22.1 -2.5% -
P< 0.001 P= 0.797 -
Plaque Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
2.45 ± 0.06 3.45 ± 0.06 3.31 ± 0.06
31.0 2.8 6.8
P< 0.001 P= 0.162 P= 0.019
29.0 -
P< 0.001 -
26.0 -4.2% -
P< 0.001 P=0.167 -
_______________________________________________________________________________________________________________________________________________________________________________________________________________
1 2 3 4 5 6 7 8
0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride. A mixture of herbs and 1,400 ppm F as sodium fluoride. 450 ppm F as sodium fluoride and 1,000 ppm F as sodium monofluorophosphate. Percent change exhibited by the 3-month mean relative to the baseline mean. A positive value indicates a reduction in index scores at the 3-month examination. Significance of paired t-test comparing the baseline and the 3-month examination. Difference between the 3-month means expressed as a percentage of the 3-month mean for the herbal/bicarbonate group. A positive value indicates a reduction in index scores in the row heading than for the herbal/bicarbonate group. Difference between the 3-month means expressed as a percentage of the 3-month mean for the fluoride group. A positive value indicates a reduction in index scores in the row heading than for the fluoride group. Significance of ANCOVA comparison of baseline-adjusted means.
Table 4. Baseline-adjusted subject mean (SE) Gingival Index and Plaque Index scores at 6 months for subjects who completed the 6-month clinical study. _______________________________________________________________________________________________________________________________________________________________________________________________________________
Between treatment comparison _______________________________________________________________
Within treatment analysis _______________________
Parameter
Treatment group
N
6-month (Mean ± S.D.)
% change4
Sig.5
versus herbal/bicarbonate ________________________
% diff.6
Sig.8
versus fluoride _________________________
% diff.7
Sig.8
_______________________________________________________________________________________________________________________________________________________________________________________________________________
Gingival Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride group3
45 45 45
0.95 ± 0.04 1.47 ± 0.04 1.57 ± 0.04
46.6 17.4 11.8
P< 0.001 P< 0.001 P< 0.001
35.4 -
P< 0.001 -
39.5 6.4 -
P< 0.001 P= 0.217 -
Plaque Index
Triclosan/copolymer/fluoride1 Herbal/bicarbonate2 Fluoride3
45 45 45
1.65 ± 0.06 3.23 ± 0.06 3.40 ± 0.06
53.5 9.0 4.2
P< 0.001 P< 0.001 P= 0.123
48.9 -
P< 0.001 -
51.5 5.0 -
P< 0.001 P= 0.125 -
_______________________________________________________________________________________________________________________________________________________________________________________________________________
1 2 3 4 5 6 7 8
0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride. A mixture of herbs and 1,400 ppm F as sodium fluoride. 450 ppm F as sodium fluoride and 1,000 ppm F as sodium monofluorophosphate. Percent change exhibited by the 6-month mean relative to the baseline mean. A positive value indicates a reduction in index scores at the 6-month examination. Significance of paired t-test comparing the baseline and the 6-month examination. Difference between the 6-month means expressed as a percentage of the 6-month mean for the herbal/bicarbonate group. A positive value indicates a reduction in index scores in the row heading than for the herbal/bicarbonate group. Difference between the 6-month means expressed as a percentage of the 6-month mean for the fluoride group. A positive value indicates a reduction in index scores in the row heading than for the fluoride group. Significance of ANCOVA comparison of baseline-adjusted means.
herbal/bicarbonate group and 3.31 for subjects assigned to the fluoride group. The percent changes from baseline were 31.0% for the triclosan/copolymer/fluoride group, 2.8% for the herbal/bicarbonate group and 6.8% for the fluoride group, of which only the changes for the triclosan/copolymer/fluoride Group and the fluoride group were statistically significant. Comparison between treatment groups - Relative to subjects assigned to the herbal/bicarbonate group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 29.0% in plaque index. Relative to subjects assigned to the fluoride group, subjects assigned to the triclosan/copolymer/fluoride exhibited a statis-
tically significant reduction of 26.0% in plaque index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a nonstatistically significant increase in plaque index scores. 6-MONTH DATA Table 4 presents a summary of the baseline-adjusted mean gingival index scores and baseline-adjusted mean plaque index scores measured after 6 months of product use. Gingival Index Comparisons versus baseline - The mean 6-month gingival index scores were 0.95 for subjects assigned to the triclosan/
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copolymer/fluoride group, 1.47 for subjects assigned to the herbal/bicarbonate group and 1.57 for subjects assigned to the fluoride group. The percent changes from baseline were 46.6% for the triclosan/copolymer/fluoride group, 17.4% for the herbal/bicarbonate group and 11.8% for the fluoride group, all of which were statistically significant. Comparison between treatment groups - Relative to subjects assigned to the herbal/bicarbonate group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 35.4% in gingival index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 39.5% in gingival index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a non-statistically significant decrease in gingival index scores. Plaque Index Comparisons versus baseline - The mean 6-month plaque index scores were 1.65 for subjects assigned to the triclosan/ copolymer/fluoride group, 3.23 for subjects assigned to the herbal/bicarbonate group and 3.40 for subjects assigned to the fluoride group. The percent changes from baseline were 53.5% for the triclosan/copolymer/fluoride group, 9.0% for the herbal/ bicarbonate group and 4.2% for the fluoride group, of which only the changes for the triclosan/copolymer/fluoride group and herbal/bicarbonate group were statistically significant. Comparison between treatment groups - Relative to subjects assigned to the herbal/bicarbonate control group, subjects assigned to the triclosan/copolymer/fluoride group exhibited a statistically significant reduction of 48.9% in plaque index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the triclosan/copolymer/fluoride exhibited a statistically significant reduction of 51.5% in plaque index scores. Relative to subjects assigned to the fluoride group, subjects assigned to the herbal/bicarbonate group exhibited a non-statistically significant decrease in plaque index scores.
Discussion Oral hygiene procedures and products have been advocated for the control of oral problems since the earliest records in history. Toothpicks and chewing sticks have been used since antiquity to help remove deposits from tooth surfaces, and tooth powders and related preparations have been used to improve mouth cleansing, especially to whiten the teeth and to freshen the breath.11 In later years, consumers have been buying toothpaste not only to clean teeth but to gain access to other health care benefits such as reduced caries rate, gingival/periodontal health and plaque control.12 The oral health industry has developed formulations to deliver these benefits by carefully selecting ingredients that go in the composition of a toothpaste. The delivery of the final outcome is largely influenced by the chosen active agents as well as by patient compliance. This double-blind, randomized clinical study provided a comparison of the clinical efficacy of an herbal/bicarbonate
Toothpaste plaque & gingivitis control 73
dentifrice to a triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm of sodium fluoride, in a silica base and to a fluoride dentifrice containing 450 ppm fluoride, as sodium fluoride, and 1,000 ppm fluoride, as sodium monofluorophosphate with respect to reducing gingivitis and dental plaque over 6 months. The herbal/ bicarbonate dentifrice is an herbal toothpaste with a high sodium bicarbonate content, and herbal extracts. In this clinical study, after 3 and 6 months of product use, subjects assigned to the triclosan/copolymer/fluoride dentifrice group exhibited statistically significant reductions in gingival index scores with respect to the herbal/bicarbonate dentifrice group. Also, after 3 weeks, 3 months and 6 months of product use, subjects assigned to the triclosan/copolymer/fluoride dentifrice group exhibited statistically significant reductions in plaque index scores with respect to the herbal/bicarbonate dentifrice group. Finally, after 3 weeks, 3 months and 6 months of product use, subjects assigned to the herbal/bicarbonate dentifrice group were not significantly different from those subjects in the fluoride dentifrice group with respect to either gingival index or plaque index scores. Since the primary endpoint was at 6 months, a repeated measures ANOVA was performed on the gingival and plaque index scores to verify the results obtained in the primary analysis (ANCOVA). The repeated measures ANOVA compared the overall profile of the treatment groups across all time points simultaneously. The results (data not shown) of the ANCOVA analysis at each time point and the repeated measures ANOVA both provided identical results and conclusions. Subjects assigned to the triclosan/copolymer/fluoride dentifrice group exhibited statistically significant reductions in both gingival index and plaque index scores with respect to the fluoride dentifrice group at all time points after baseline. There is copious published evidence showing that toothpastes containing 0.3% triclosan/2% copolymer, and fluoride reduce plaque, gingival inflammation and gingival bleeding when compared to toothpastes with fluoride alone. These reductions are evident regardless of initial plaque and gingivitis levels, or whether a baseline oral prophylaxis had taken place or not. A recent Cochrane Review7 presented evidence that toothpaste containing 0.3% triclosan/2% copolymer and fluoride provides significant reductions in plaque and gingivitis, as well as a small reduction in coronal caries relative to toothpaste with fluoride alone. The safety of the product is also well documented; no serious adverse effects were reported in clinical studies up to 3 years in duration.7 The benefits of herbal/bicarbonate dentifrice are much less well documented. Panutti et al13 assessed plaque and gingivitis in a randomized, double-blind clinical trial in which subjects were randomly allocated into either the test group (the herbal/bicarbonate dentifrice) or the control group (standard dentifrice with fluoride). Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index, and gingivitis was evaluated with the Löe and Silness Gingival Index. They found that there was no significant difference between groups in relation to the median plaque and gingival scores, at baseline and at the end of the 21-day period. Those results were confirmed by the
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current study. While the herbal/bicarbonate dentifrice may behave similarly to other herbal based fluoride dentifrices in reducing plaque and gingivitis,14,15 the present study showed that the efficacy of the herbal/bicarbonate dentifrice was substantially inferior to that of a fluoride toothpaste containing 0.3% triclosan/2% copolymer. The unique combination of triclosan and copolymer has shown clinical evidence of antibacterial activity against specific pathogens, as well as modulation of inflammatory pathways.16-18 In conclusion, the results of this single-center, double-blind, parallel-group, and randomized clinical study support the use of the triclosan/copolymer/fluoride dentifrice as it was superior to the herbal/bicarbonate dentifrice. The herbal/bicarbonate toothpaste was equivalent to the fluoride dentifrice in its effect on plaque and gingivitis over 6 months of product use. a. b.
Colgate-Palmolive Company, New York, NY, USA. GlaxoSmithKline Company, Brentford, UK.
Disclosure statement: This research was funded by the Colgate-Palmolive Company; Drs. Kraivaphan, Amornchat, Triratana, Dibart and Mr. Mateo were funded by the Colgate-Palmolive Company to conduct this study. Drs. Morrison and Zhang are employees of the Colgate-Palmolive Company. Clinical Registration: NCT# 02080273 (from www.clinicaltrials.gov). Drs. Triratana and Kraivaphan are Associate Professors, Mahidol University, Bangkok, Thailand. Dr. Amornchat is Associate Professor, Western University, Pathumthani, Thailand. Mr. Mateo is an independent consultant, LRM Statistical Consulting, West Orange, New Jersey, USA. Dr. Dibart is Professor and Chair, Department of Periodontology, School of Dental Medicine, Boston University, Boston, Massachusetts, USA. Dr. Morrison is Associate Director of Global Technology Center, and Dr. Zhang is Worldwide Director of Global Technology Center, Colgate-Palmolive, Piscataway, New Jersey, USA.
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