ADVANCES IN DENTAL PRODUCTS |
JADA Continuing Education
Clinical effect of a new liquid dentifrice containing triclosan/copolymer on existing plaque and gingivitis
TERDPHONG TRIRATANA, D.D.S.,
KEDAR N. RUSTOGI, D.D.S.,
ANTHONY R. VOLPE, D.D.S., M.S.,
WILLIAM DeVIZIO, D.M.D.,
MARGARET PETRONE, J.D. and
MARTIN GINIGER, D.M.D., Ph.D.
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ABSTRACT
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Background. Dentifrices traditionally have been formulated as pastes or gels. However, liquid varieties recently have become available. The authors conducted a study to determine whether a fluoridated liquid product with added triclosan and a polyvinyl methyl ether/maleic acid, or PVM/MA, copolymer delivery system is efficacious for the control of supragingival plaque and gingivitis.
Methods. The authors conducted a six-month, double-blind, parallel, stratified clinical study in accordance with American Dental Association guidelines for the clinical evaluation of antiplaque/antigingivitis products. Subjects who qualified with a suitable amount of existing plaque and gingivitis were given one of two dentifrices: an "experimental" liquid dentifrice containing 0.3 percent triclosan, 2.0 percent PVM/MA copolymer and 0.243 percent sodium fluoride, or NaF, in a silica base; or a "placebo" dentifrice containing 0.243 percent NaF in a silica base. The authors collected subjects’ plaque and gingival index scores at baseline, three months and six months.
Results. The results of the study indicate that the use of the experimental liquid dentifrice provided a significant reduction in existing levels of plaque and gingivitis as compared with the placebo standard dentifrice. At six months, the experimental group demonstrated a 34.9 percent reduction in plaque formation and a 25.7 percent reduction in gingivitis as compared with the placebo group (P < .001).
Conclusions. When compared with the placebo, the experimental dentifrice had a significantly better ability to reduce plaque and gingivitis. When compared with results reported in the literature, this new form of dentifrice achieved results comparable in efficacy to those of traditional dentifrice pastes with matching active ingredients.
Clinical Implications. This study confirms that a liquid dentifrice containing a triclosan/copolymer/NaF delivery system is efficacious in its ability to reduce existing plaque and gingivitis.
Dentifrices have been manufactured throughout the world in different forms throughout the ages. Ancient Greek and Roman civilizations were known to have developed tooth "powders" containing pumice, talcum, coral powder and alabaster.1 Historians report that both a physician for the Roman emperor Claudius I and the Greek physician Hippocrates developed their own formulations that contained not only abrasives but also what were thought to be "therapeutic" substances.1,2 For example, myrrh or niter was added as an astringent, presumably to promote gingival and oral mucosal health.2 Today’s dentifrices follow many of the same principles that were developed centuries ago, the difference being that modern products have a higher degree of compositional sophistication and improvements in esthetics and therapeutic value.2
This study establishes that a liquid dentifrice containing a triclosan/copolymer/sodium fluoride delivery system is efficacious in reducing existing plaque and gingivitis.
Toothpaste manufacture over the last several decades has been driven by a combination of dental research findings and marketing forces. Today’s dental patient expects a dentifrice to remove dental plaque and leave teeth smooth, improve gingival health, reduce the incidence of dental caries and freshen breath.2 Gel and striped products also have increased in popularity in recent years because of their enhanced esthetic physical properties. Because patients have shown a preference for new dentifrice forms with advanced physical properties, several manufacturers have now introduced liquid dentifrices into the marketplace.
The addition of the molecule triclosan is another relatively new concept in toothpaste manufacture. Triclosan (2,4,4' trichloro-2'-hydroxydiphenyl ether), a noncationic antimicrobial agent, has been used extensively for 30 years in consumer products, particularly deodorants, soaps and other dermatological preparations.3 Recently, triclosan has been included in oral health care products, such as dentifrices and mouthrinses.3,4 Clinical studies in humans have shown it to be safe to use, causing no systemic or local side effects and no disturbance of the oral microbial ecology.5,6 Furthermore, the addition of triclosan to oral care products has been shown to reduce dental plaque, gingivitis and calculus.4,5 However, to achieve these benefits, it has been necessary to increase triclosan’s efficacy by developing a delivery system that prolongs its residence time in the oral cavity. A copolymer of polyvinyl methyl ether, or PVM, and maleic acid, or MA, has been found to be well-suited for this purpose, since it retained triclosan on the soft and hard surfaces of the oral cavity for several hours.4,5,7–9
The literature has shown that a paste dentifrice containing 0.3 percent triclosan, 2 percent PVM/MA and 0.243 percent NaF in a silica base is effective in reducing dental plaque, gingivitis and calculus than other fluoridated dentifrices.4,5,7–9 No such study ever has been reported for a liquid dentifrice with a similar composition. Therefore, the objective of the double-blind investigation we report here is to determine whether a toothpaste that combines these two new toothpaste technologies—a liquid triclosan/copolymer dentifrice—is clinically efficacious for the control of existing supragingival plaque and gingivitis.
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MATERIALS AND METHODS
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Study group and design.
We conducted a six-month, double-blind, parallel, stratified clinical study in accordance with the published 1986 American Dental Association guidelines (and the 1994 revisions of those guidelines) for the clinical evaluation of antiplaque/antigingivitis products.10,11 We enrolled 124 adult men and women in the study, having recruited subjects by means of a call to the local community located in the general vicinity of the site where the study was conducted. The participants were between the ages of 20 and 60 years, were in generally good health and had a minimum of 20 scorable teeth.
Participants were enrolled in the study if they met the following inclusion criteria: had signed an informed consent form before baseline examination; had a mean baseline modified Quigley-Hein, or Q-H, Plaque Index score of 1.5 or greater and a mean modified Löe-Silness, or L-S, Gingival Index score of 1.0 or greater; used no orthodontic appliances; used no removable prostheses; had no tumors or advanced periodontal disease; and had undergone no antibiotic therapy during the two weeks before the start of the study.
We used a double-blind, stratified, parallel-group design. We stratified qualifying subjects according to their baseline plaque and gingival index scores, and randomly assigned each of them to one of the two study groups. The experimental group used a liquid containing 0.3 percent triclosan, 2.0 percent PVM/MA copolymer and 0.243 percent sodium fluoride, or NaF, in a silica base (Colgate Total Liquid Toothpaste, Colgate-Palmolive Co., New York City). The placebo group used a liquid dentifrice containing 0.243 percent NaF in a silica base.
Baseline examinations and subsequent examinations were performed by Drs. Terdphong Triratana and Titikan Fongsmut, both members of the faculty of dentistry at Mahidol University in Bangkok, Thailand. The initial examination consisted of an extraoral and intraoral hard- and soft-tissue inspection to assess plaque on the surfaces of teeth and degrees of gingival inflammation. If a subject met the inclusion criteria previously discussed and had at least moderate plaque and gingival inflammation (specifically, a Q-H score 
1.5 and an L-S score 1.0; see the description of scoring methods below), that subject was deemed qualified and was randomly assigned to a study group.
After qualification and study group assignment, subjects received an initial supply of their assigned dentifrice along with an adult-sized, soft-bristled toothbrush, and they were instructed to brush their teeth for one minute twice daily (morning and evening) in their customary manner using only the dentifrice and toothbrush provided, and to refrain from any other oral hygiene procedures throughout the duration of the study. The dentifrices were distributed in plain white wrappers to ensure the double-blind nature of the study. Clinical study materials were resupplied at regularly scheduled intervals. When new tubes of dentifrice were issued, subjects returned their previous tubes so that compliance with dentifrice use could be monitored.
Participants returned to the clinical facility after three months and again after six months of product use, having refrained from oral hygiene procedures for eight hours before each visit. They were then re-examined by the same investigators who performed their initial assessments for supragingival plaque and gingivitis using the same scoring procedures that were used at baseline. Also at these times, and as was done in the baseline examination, the examiner visually inspected the hard and soft tissues of the oral cavity for the presence of any adverse or unusual reactions.
Clinical scoring procedures.
The examiners scored plaque according to Turesky and colleagues’12 modification of the Q-H Plaque Index.13 Each tooth was divided into six surfaces, three facial and three lingual: mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual. The examiners disclosed and scored supragingival plaque on each surface according to the criteria listed in Figure 1
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Figure 1. Plaque scoring methodology. A. The scoring of the Quigley-Hein Plaque Index. SP: Score of plaque. This is derived by adding up the scores for all teeth and dividing that total by the total number of teeth assessed. In the case shown here, a total score of 15 divided by a total of six teeth assessed yields a final score of 2.5. B. The scoring of the Plaque Severity Index, or PSI. This score is a percentage, derived by dividing the total number of teeth that have high scores (scores of 3 or higher) by the total number of teeth assessed. In the case shown here, three teeth had scores of 3 or higher; dividing that by the total number of teeth scored, six, yields a score of 50 percent, or 0.5. (Figure courtesy of Dr. Anthony R. Volpe, Colgate-Palmolive Co., New York.)
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The examiners scored gingivitis according to Talbott and colleagues’14 modification of the L-S Gingival Index.15 Each tooth was divided into the same six surfaces as with the Q-H Plaque Index, and the examiners scored each surface as depicted in Figure 2. In both of the above scoring procedures, third molars and any teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. We obtained whole-mouth mean scores by averaging the values the examiners had obtained from all scorable surfaces in the mouths of subjects in each study group.
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Figure 2. Gingivitis scoring methodology. The Gingivitis Severity Index score is a percentage of sites that demonstrate bleeding, derived by dividing the total number of teeth that have high scores (scores of 2 or 3) by the total number of sites scored. (Figure courtesy of Dr. Martin Giniger, University of Medicine and Dentistry of New Jersey, Newark.)
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In addition to the plaque and gingival indexes discussed above, we calculated a plaque severity index, or PSI, score and a gingivitis severity index, or GSI, score. These indexes measure the proportion of the surfaces in the mouth that have received high scores on the respective indexes. A subject’s PSI score is a proportion that reflects what percentage of his or her teeth had high levels of plaque. A score of 0 indicates that 0 percent of teeth received a high Q-H Plaque Index score—a score of 3.0 or higher. A score of 1.0 indicates that 100 percent of teeth examined in a person’s mouth had high Q-H Index scores. People with a PSI of 0.5 or greater are considered to have a considerable amount of plaque on teeth. A subject’s GSI score is a proportion that reflects the percentage of a person’s gingiva that is bleeding. Therefore, the GSI score (like the PSI score) can range from 0 to 1.0. A score of 0 indicates that 0 percent of gingivae received a high L-S Gingival Index score (2.0 or higher). A score of 1.0 indicates that 100 percent of the gingivae examined in a subject’s mouth had moderate to high levels of inflammation (bleeding). People with a GSI score of 0.5 or greater are considered to have a considerable level of gingivitis.
Statistical methods.
We analyzed the baseline data for normality of distribution of variables using the Kolmogorov-Smirnov Goodness of Fit test. We compared the scores on both plaque indexes and both gingivitis indexes between the placebo group and the experimental group by means of analysis of variance and analysis of covariance at each measurement period, using the baseline scores from all respective indexes as the covariates. All statistical tests of hypotheses were two-sided and used a level of significance of 
= .05.
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RESULTS
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Of the 124 participants who met the entry criteria and enrolled at baseline, 119 (96 percent) participated in the study for the entire six months. Participants who did not complete the study did so for reasons unrelated to the use of either of the two liquid dentifrices in the study. Throughout the study, the clinical examiners observed no adverse reactions in oral hard or soft tissues.
Table 1 presents a summary of the age and sex of the study population. There were no statistical differences between the two dentifrice groups with regard to age or sex. The treatment groups appeared to be well-balanced with regard to these characteristics.
Baseline data.
Table 2 presents the summary of whole-mouth clinical data at the baseline examination for the subjects who completed the entire six-month study. Statistical analysis indicated that there were no real differences between the two dentifrice groups with regard to PSI and GSI scores (P > .05). Thus, the treatment groups were well-balanced with regard to baseline clinical measurements.
Three-month data.
Table 3 presents a comparison of the mean modified Q-H Plaque Index scores and mean modified L-S Gingivitis Index scores for the two groups after three months’ use of the assigned dentifrice. The Q-H means were 2.65 and 2.10, respectively, for the placebo and experimental dentifrice groups. Thus, the experimental dentifrice provided a 20.8 percent reduction in supragingival plaque formation, compared with the placebo dentifrice (P > .001). The L-S means were 1.54 and 1.32 for the placebo and experimental dentifrice groups, respectively. Thus, the experimental dentifrice provided a 14.3 percent reduction in gingivitis as compared with the placebo dentifrice (P < .01).
Six-month data.
Table 4 presents a comparison of the mean modified Q-H scores and mean modified L-S scores for the two groups after six months’ use of the assigned dentifrice. The Q-H means for the subjects who completed the clinical study were 2.41 and 1.57, respectively, for the placebo and experimental dentifrice groups. Thus, the experimental dentifrice provided a 34.9 percent reduction in supragingival plaque formation, compared with the placebo dentifrice (P > .001). The modified L-S means for the subjects completing six months of clinical study were 1.44 and 1.07 for the placebo and experimental dentifrice groups, respectively. Thus, the experimental dentifrice provided a 25.7 percent reduction in gingivitis, as compared with the placebo dentifrice (P < .001).
Figure 3 describes the percentage reduction of plaque and gingivitis calculated vs. baseline levels after six months of using the experimental or placebo dentifrice. The figure clearly shows that the new liquid dentifrice is superior to the placebo in all four indexes measured.
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Figure 3. Relative performance of the placebo product vs. the experimental product at subjects’ six-month examinations. Bars represent the percentage of reduction of plaque or gingivitis from baseline levels.
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DISCUSSION
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Dentifrice has been formulated in a variety of different modes over the years, but the paste form is the traditional one and the one most widely available today. However, changing patient preferences and more sophisticated manufacturing processes have led to gel and liquid dentifrices’ becoming more popular in the world marketplace. Even though liquid dentifrice has been marketed in Europe since 1994, there have not been many clinical studies that determined whether new liquid formulations have the same clinical efficacy as their paste counterparts.16 Also, before this study was conducted, it had not been determined if a liquid dentifrice containing triclosan/copolymer would be efficacious for the control of supragingival plaque and gingivitis.
However, the results of our study indicate that the use of the experimental liquid dentifrice provides a significant reduction in existing levels of plaque and gingivitis as compared with the placebo standard dentifrice. At six months, the experimental group demonstrated a 34.9 percent reduction in plaque formation and a 25.7 percent reduction in gingivitis, as compared with the placebo group (P < .001).
Our findings also are in agreement with data presented by Triratana and colleagues17 and Lindhe and colleagues,18 who studied the effect on established plaque and gingivitis of a traditional toothpaste containing triclosan/copolymer. These authors reported that after six months, the members of a test group had approximately 30 percent less plaque and 20 percent less gingivitis than did control subjects. They also reported that the effect of the active compound was more pronounced at sites in which plaque and gingivitis were heavier or more severe, a finding similar to ours. Therefore, it has been demonstrated conclusively that a dentifrice formulation containing triclosan/copolymer is highly effective in the reduction of plaque and gingivitis.
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CONCLUSION
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Our study establishes for the first time that a liquid dentifrice containing a triclosan/copolymer/NaF delivery system is efficacious in reducing existing plaque and gingivitis. Dental professionals should be able to recommend this new category of dentifrice to patients with confidence. Given the successful clinical performance of the experimental liquid dentifrice tested in this study, dental professionals may reasonably expect to see commercially available products of this genre become available in the consumer marketplace over time.
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FOOTNOTES
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Dr. Triratana is an associate professor and the chairman, Department of Oral Pathology, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.
Dr. Rustogi is an associate director, Clinical Dental Research, Colgate-Palmolive Technology Center, Piscataway, N.J.
Dr. Volpe is vice president, Clinical Dental Research, Colgate-Palmolive Technology Center, Piscataway, N.J.
Dr. DeVizio is the worldwide director, Clinical Dental Research, Colgate-Palmolive Technology Center, 909 River Road, Piscataway, N.J. 08854, e-mail "william_devizio{at}colapl.com". Address reprint requests to Dr. DeVizio.
Ms. Petrone is an associate director, Clinical Dental Research, Colgate-Palmolive Technology Center, Piscataway, N.J.
Dr. Giniger is an associate professor, Department of Oral Pathology, Biology and Diagnostic Sciences, University of Medicine and Dentistry of New Jersey, New Jersey Dental School, Newark.
The authors gratefully acknowledge the significant contributions of Dr. Titikan Fongsmut and Dr. Petcharat Kraivaphan of the faculty of dentistry, Mahidol University, Bangkok, Thailand.
Only the authors identified as employees of Colgate-Palmolive Co., New York City, are affiliated with the company and have a financial interest in the product used in this study (Colgate Total Liquid Toothpaste) because of their employment status. In addition to supplying the product, Colgate-Palmolive Co. paid for the study to be conducted. Payment covered salary of study personnel and expenses associated with conduct of the study.
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REFERENCES
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- Kanner L. Folklore of the teeth. New York: Macmillan; 1928: 100–56.
- Pader M. Oral hygiene products and practice. New York: Marcel Dekker; 1988:419–87.
- Gaffar A, Afflitto J, Nabi N. Chemical agents for the control of plaque and plaque microflora: an overview. Eur J Oral Sci 1997;14:502–7.
- DeSalva SJ, Kong BM, Lin YJ. Triclosan: a safety profile. Am J Dent 1989;2(special issue):185–96.[Medline]
- Gaffar A, Afflito J, Nabi N, Herles S, Kruger I, Olsen S. Recent advances in plaque, gingivitis, tartar and caries prevention technology. Int Dent J 1994;44:63–70.[Medline]
- Palomo F, Wantland L, Sanchez A, et al. The effect of three commercially available dentifrices containing triclosan on supragingival plaque formation and gingivitis: a six-month clinical trial. Int Dent J 1994;44:75–81.[Medline]
- Deasy MJ, Singh SM, Rustogi KN, et al. Effect of a dentifrice containing triclosan and a copolymer on plaque formation and gingivitis. Clin Prev Dent 1991;13:12–9.[Medline]
- Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin HM. A review of plaque, gingivitis, calculus and caries clinical efficacy studies with fluoride dentifrices containing triclosan and PVM/MA copolymer. J Clin Dent 1993;4(special issue):31–41.[Medline]
- Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin HM. A review of plaque, gingivitis, calculus and caries clinical efficacy studies with a fluoride dentifrice containing triclosan and PVM/MA copolymer. J Clin Dent 1996;7(special issue):S1–S14.[Medline]
- American Dental Association. Council of Dental Therapeutics guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. JADA 1986;112:529–32.[Medline]
- Imrey PB, Chilton NW, Pihlstrom BL, et al. Recommended revisions to American Dental Association guidelines for acceptance of chemotherapeutic products for gingivitis control. J Periodontal Res 1994;29:299–304.[Medline]
- Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol 1970;41:41–3.[Medline]
- Quigley GA, Hein JW. Comparative cleansing efficacy of manual and power brushing. JADA 1962;65:26–9.[Medline]
- Talbott K, Mandel I, Chilton N. Reduction of baseline gingivitis scores with repeated prophylaxes. 1977;4:28–9.
- Löe H, Silness J. Periodontal disease in pregnancy. Acta Odontol Scand 1963;21:533–7.[Medline]
- Claydon NC, Addy M. A 24-h regrowth study to evaluate the plaque inhibitory properties of a proprietary liquid dentifrice. J Clin Periodontol 1999;26:286–8.[Medline]
- Triratana T, Tuongratanaphan S, Rustogi K, Petrone M, Volpe A, Petrone D. Plaque/gingivitis effect of a triclosan/copolymer dentifrice(IADR abstract 1850). J Dent Res 1993;72:334.
- Lindhe J, Rosling B, Socransky SS, Volpe AR. The effect of a triclosan-containing dentifrice on established plaque and gingivitis. J Clin Periodontol 1993;20:327–34.[Medline]
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J. C. Gunsolley
A meta-analysis of six-month studies of antiplaque and antigingivitis agents
J Am Dent Assoc,
December 1, 2006;
137(12):
1649 - 1657.
[Abstract]
[Full Text]
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ABSTRACT
MATERIALS AND METHODS
