Comparative antiplaque and antigingivitis effectiveness of a chlorhexidine and an essential oil mouthrinse: 6-month clinical trial.

OBJECTIVES: The objective of this study was to compare the antiplaque and antigingivitis effectiveness and the side-effect profiles of an essential oil-containing mouthrinse and a chlorhexidine-containing mouthrinse. MATERIAL AND METHODS: One hundred and eight qualifying subjects, aged 20-57 years, were randomized into three groups: essential oil mouthrinse (ListerineAntiseptic); 0.12% chlorhexidine mouthrinse (Peridex); or 5% hydroalcohol negative control. At baseline, subjects received a complete oral soft tissue examination and scoring of the Loe-Silness gingival index (GI), Quigley-Hein plaque index (PI), Volpe-Manhold calculus index (CI), and Lobene extrinsic tooth stain index (SI). Following a complete dental prophylaxis, subjects started rinsing twice daily with their respective mouthrinse as an adjunct to their usual mechanical oral hygiene procedures. One of the rinses on each weekday was supervised. Subjects were reexamined at 3 and 6 months. The treatment groups were compared with respect to baseline demographic and clinical variables. The primary efficacy variables were GI and PI. Intergroup differences for all clinical variables were tested at 3 and 6 months using appropriate statistical procedures. RESULTS: All of the 108 randomized subjects were evaluable at 3 months, and 107 subjects were evaluable at 6 months. There were no statistically significant differences among the three groups at baseline, with the exception that the control group PI was significantly lower than that of the essential oil group (p<0.05) and the chlorhexidine group (p<0.001), and the essential oil mouthrinse group had a significantly greater number of subjects than the control group with body region SI scores > or =1.0 (p=0.021). At 6 months, the essential oil and chlorhexidine mouthrinses produced statistically significant (p<0.001) GI reductions of 14.0% and 18.2%, respectively, and statistically significant (p<0.001) PI reductions of 18.8% and 21.6%, respectively, compared with the control and were not statistically significantly different from each other with respect to plaque and gingivitis reduction. The chlorhexidine mouthrinse group had significantly more calculus and extrinsic tooth stain than either the essential oil mouthrinse group or the control group. CONCLUSION: This 6-month controlled clinical study demonstrated that the essential oil mouthrinse and the chlorhexidine mouthrinse had comparable antiplaque and antigingivitis activity. Insofar as side effects associated with the chlorhexidine mouthrinse may limit patient compliance, it is suggested that each product can have a distinct role in the management of patients with periodontal diseases.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Efficacy of a dentifrice containing zinc citrate for the control of plaque and gingivitis: a 6-month clinical study in adults.

The objective of this 6-month, double-blind, clinical study, conducted in harmony with American Dental Association (ADA) guidelines, was to evaluate the efficacy of a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base (zinc citrate dentifrice) for the control of supragingival plaque and gingivitis, compared to a control dentifrice containing 0.76% sodium monofluorophosphate in a silica base (control dentifrice). Adult men and women from the Atlanta, Georgia, area were entered in the study and stratified into two treatment groups, which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were conducted after 3 months and again after 6 months' use of the study dentifrices. Ninety-nine participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the zinc citrate dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group, based on whole-mouth data. At the 6-month examination, the magnitude of these reductions met or exceeded 18% for both plaque and gingivitis (25.3% for plaque; 18.8% for gingivitis). The effect of the zinc citrate dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis, indicating a statistically significant (50.2%) reduction in severe plaque and a statistically significant (66.7%) reduction in severe gingivitis over the control dentifrice after 6 months of use. Similar findings were observed for data obtained from proximal, lingual, and posterior sites. Among the sites that indicated a tendency toward high levels of plaque or gingivitis based on the baseline scores, substantially fewer sites tended to continue to present such high levels at follow-up exams in the zinc citrate dentifrice group than in the control dentifrice group. Thus, in accordance with the 1986 guidelines published by the ADA and the 1994 revision published by the Task Force on Design and Analysis in Dental and Oral Research, the results of this study support the conclusion that a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base is clinically efficacious for the control of supragingival plaque and gingivitis.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 3: A 6-month plaque/gingivitis clinical study, southeast USA.

This 6-month, double-blind clinical study, also following the American Dental Association guidelines, investigated the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice in controlling supragingival dental plaque and gingivitis. The same dentifrice, containing 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base was used. Adult men and women from the Atlanta, Georgia, area received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. As in the first study, plaque and gingivitis examinations were conducted after 3 months and again after 6 months of using the dentifrices. At both the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study reflect those found in the New Jersey study, i.e., supporting the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

Effect of rinsing time on antiplaque-antigingivitis efficacy of listerine.

This double-blind, controlled clinical study compared the effectiveness of 30- and 60-s listerine rinses in both inhibiting the development of, and reducing existing, supragingival plaque and gingivitis, using an experimental gingivitis model. 94 subjects completed this study. For each subject, a modified gingival index, modified Quigley-Hein plaque index and Eastman interdental bleeding index were recorded at baseline and at 2 weeks. Following the baseline examinations, subjects received half-mouth prophylaxes, and began 2 x daily supervised rinsing either with listerine for 30 or 60 s or with a control mouthrinse for 30 s as their sole oral hygiene measure. Statistical analysis (ANCOVA) showed that both the 30- and 60-s listerine rinses were significantly (p < 0.01) more effective than the control in inhibiting and reducing plaque, gingivitis and gingival bleeding. Although 60-s rinses with listerine were significantly more effective (p < 0.01) than 30-s rinses in controlling plaque, the 2 rinse durations were similarly effective in controlling interdental bleeding and gingivitis. This study confirms the recommendation of 2x daily rinsing with listerine for 30 s as an effective regimen for gingivitis control.

Clinical efficacy of listerine in inhibiting and reducing plaque and experimental gingivitis.

103 adult subjects completed a supervised 2-week double-blind controlled clinical study to determine the effect of using either listerine antiseptic (LA) or its vehicle control (VC), as the only oral hygiene procedure, in inhibiting the development of and in reducing plaque and experimental gingivitis. Following baseline examinations, half-mouth prophylaxes were performed on each subject, who continued normal oral hygiene and returned 4 or 5 days later for a second baseline. Subjects then rinsed, under supervision, either 2 or 4 times daily for 2 weeks with LA or twice daily with VC, but suspended all other oral hygiene measures. Plaque and gingivitis were evaluated at baselines and after 2 weeks. Subjects using LA 2 or 4 times a day as the only oral hygiene procedure for 2 weeks demonstrated highly significant inhibition and reduction of both supragingival plaque and gingival inflammation compared to those using VC.