The relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico.

The objective of this research was to evaluate the anticaries effectiveness of a low-dose (500 ppm F, low-NaF) sodium fluoride dentifrice, a high-dose (2,800 ppm F, high-NaF) sodium fluoride dentifrice and an experimental 0.454% stabilized stannous fluoride (1,100 ppm F) with sodium hexametaphosphate (SnF2-HMP) dentifrice, each relative to a standard 1,100 ppm F sodium fluoride positive control dentifrice. Subjects (n = 955, with approximately 239 per group) with a mean age of 10.6 (approximately 9-12 years) were randomly assigned to one of four dentifrice treatments. Two calibrated examiners independently measured visual-tactile caries as DMFS that was supplemented with a radiographic examination at baseline, 12 months and 24 months for each subject. Generally similar results were independently observed by both examiners at the conclusion of the 2-year study period. Considering all subjects that attended at least 60% of the supervised brushing sessions, statistically significantly less caries was observed in the high-NaF group compared to the control group. Similarly, statistically significantly less caries was observed in the SnF2-HMP group as compared to the control group. Differences in caries increments between the low-NaF and control groups were not statistically significant. One of the examiners observed these same statistically significant differences after 1 year. In conclusion, the results of this clinical trial indicated that while no difference in caries increments was observed between the low-NaF and control groups, both the high-NaF and the SnF2-HMP groups experienced significantly fewer lesions than the control group.

Plaque regrowth effects of a triclosan/pyrophosphate dentifrice in a 4-day non-brushing model.

Triclosan is a lipophilic antimicrobial agent which, when present in an aqueous dentifrice vehicle, is complexed by or in close contact with polymers and surface-active molecules, emulsifying agents, flavoring oils and other hydrophobic ingredients. Because of this, dentifrice products containing triclosan may not have triclosan in a bioavailable state and, hence, the products themselves can not be assumed to possess antimicrobial activity. In order to determine the antimicrobial effects on dental plaque of a triclosan/pyrophosphate dentifrice relative to a negative control (without triclosan or pyrophosphate), a crossover 4-day non-brushing study was conducted. Thirty-four subjects were enrolled in this randomized two-period, double-blind crossover investigation with thirty-three subjects completing all aspects. Following a baseline plaque examination and complete plaque removal at the start of the first 4-day treatment period, subjects initiated a twice-daily supervised dosing regimen, during which they rinsed with their first assigned dentifrice in slurry form while refraining from tooth-brushing and all other oral hygiene procedures. Evaluations to quantify test product effects on plaque were conducted on Day 5. After a week-long interim washout period, subjects repeated the twice daily rinsing regimen over Days 1-4 of Treatment Period 2 with their second assigned product, again with examinations on Day 5. Analysis of data demonstrated subjects had significantly (p = 0.0296) less plaque when rinsing with the triclosan/pyrophosphate dentifrice slurry as compared to the negative control dentifrice slurry; the relative treatment difference as determined by the primary examiner was 12.7%. A trainee examiner observed a 16.0% reduction on a subset of subjects (p = 0.0139). This efficacy result compares favorably with results from other studies of triclosan-containing products. The examinations for oral safety demonstrated no meaningful clinical differences between the triclosan/pyrophosphate dentifrice and control dentifrice.

Assessing the efficacy and safety of an electric interdental cleaning device.

BACKGROUND: Although routine interdental cleaning is important and recommended by dental professionals, compliance has been relatively low. To aid in improving compliance, an electrically powered device has been developed. METHODS: This six-month randomized, single-blinded, parallel-group study was conducted to compare the long-term efficacy and safety of a new interdental cleaning device (Braun Oral-B Interclean, model ID2) with those of an ADA-approved waxed dental floss in healthy adults. RESULTS: The authors found no statistically significant difference between the two products with respect to the gingival index or gingival bleeding index after three or six months of use. A one-time product use, at the six-month examination, confirmed the equivalency of the two methods with respect to removal of dental plaque. The oral soft-tissue status of both groups of subjects also remained comparable throughout the study. CONCLUSION: Use of the interdental cleaning device and dental floss resulted in comparable benefits with respect to gingival health and plaque removal. CLINICAL IMPLICATIONS: Although it was not shown to be an improvement over dental floss, the cleaning device was comparable in every respect. Since it can be used with one hand and does not require as much dexterity as floss, the device warrants consideration by those who lack the motivation or are unable to use dental floss.

A crossover clinical investigation of the safety and efficacy of a new oscillating/rotating electric toothbrush and a high frequency electric toothbrush.

PURPOSE: To compare the efficacy on plaque, gingivitis and calculus of an oscillating/rotating power toothbrush (Braun Oral-B Ultra Plaque Remover-D9) and a high frequency toothbrush (sonicare). MATERIALS AND METHODS: A 6-week, randomized crossover study was carried out. A total of 62 healthy adult subjects completed the study and were assessed for plaque control, gingival condition and calculus control. At the end of the study, subjects completed a questionnaire which assessed their preferences for the two devices. RESULTS: Both toothbrushes were found to be safe and effective, but a significantly lower gingival index (P = 0.002) and a lower calculus index (P = 0.022) was found in the D9 group. Assessment of patient preferences revealed that a significant majority of subjects in the study (65%) preferred the D9 to the high frequency toothbrush (27%). It is concluded that the D9 may offer greater potential for the maintenance of good gingival condition than the high frequency toothbrush, and that the greater preference for the D9 may be important with respect to long-term compliance. The implications of these findings are discussed.

The effect of chewing sugar-free gum after meals on clinical caries incidence.

To determine the effect of chewing sugar-free gum on caries incidence, the authors conducted a randomized clinical study. A total of 1,402 children in Puerto Rico, in grades 5 through 7 at baseline, completed the study. They were randomized by classroom into a control group or chewing gum group; those in the gum group were instructed to chew sugar-free gum for 20 minutes after each of three meals a day. Clinical and radiographic evaluations were performed at baseline and after two and three years. The results show that all subjects and high-risk subjects, respectively, in the gum group developed 7.9 percent and 11.0 percent fewer decayed, missing or filled surfaces than subjects in the control group. Based on these findings, the authors concluded that chewing sorbitol-based sugar-free gum after eating significantly reduces the incidence of dental caries.

The clinical effect of dentifrices containing stabilized stannous fluoride on plaque formation and gingivitis--a six-month study with ad libitum brushing.

The effects of stabilized 0.454% stannous fluoride dentifrices on supragingival plaque, gingival inflammation and gingival bleeding were studied in 549 adult male and female subjects who completed a six-month, double blind clinical study. Following an oral prophylaxis, subjects were randomly assigned to brush with one of the following dentifrices: 1) 0.454% SnF2 stabilized with 2.08% sodium gluconate, 2) 0.454% SnF2 stabilized with 4.16% sodium gluconate, 3) an experimental dentifrice, or 4) 0.243% NaF control dentifrice. Follow-up examinations were conducted at 3 and 6 months. Compared to the control dentifrice at 6 months, stannous fluoride dentifrices stabilized with 2.08% or 4.16% sodium gluconate significantly reduced gingivitis by 18.8% and 18.0%, respectively. There were no statistically significant differences between the two stabilized SnF2 groups with respect to their beneficial effects on gingival health. Gingival bleeding was also reduced, relative to the control dentifrice, for both stabilized SnF2 dentifrices. However, these differences were not statistically significant at p=0.05. The stabilized SnF2 dentifrices were not significantly different from the control dentifrice in their effects on supragingival plaque. No significant differences in adverse oral soft tissue effects were observed between the test and control groups. As expected, accumulation of extrinsic tooth stain increased in the stabilized SnF2 groups. However, the difficulty in removing accumulated dental stain was similar between the control and stabilized SnF2 dentifrices. Since use of SnF2 dentifrices has been reported to produce tooth stain, gingivitis examinations were done with and without custom-made tooth covers to evaluate the potential for examiner bias. Comparable gingivitis and gingival bleeding benefits were observed when the evaluations were conducted with or without the tooth covers. Results from this study support that 0.454% stabilized stannous fluoride dentifrices can provide an important adjunct to the prevention and control of gingivitis when used in combination with regular personal oral hygiene procedures and professional care.

Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing.

This trial tested the adjunctive effects of a 0.12% chlorhexidine rinse (Peridex) upon gingival healing following scaling and root planing. Assessments were made on reduction in plaque (Pl), gingivitis (GI), pocket depth and gingival bleeding as measures of treatment benefit. All subjects had Class II, III or IV periodontal conditions. Following baseline examinations, subjects received a gross supragingival scaling and polishing. Subjects were separated by sex and periodontal classification, arrayed by GI scores, and randomly assigned to either the chlorhexidine rinse or a placebo rinse. Subjects were instructed to rinse with 1/2 ounce of their assigned products for 30 seconds twice daily. Following two weeks of product use, the clinical examinations were repeated and two randomly selected, opposing contralateral quadrants were scaled and root planed. After two more weeks of product use (week 4), clinical examinations were repeated and the remaining quadrants were scaled and root planed. At week 6, final clinical examinations were conducted. Since half-mouths were treated at different times and exposed to the treatment rinses for different periods, the data were analyzed for the half-mouths independently 2 and 4 weeks after gross scaling, and 2 and 4 weeks after root planing. A total of 94 subjects (47 in each treatment group) completed all phases of the trial. Gingival healing following scaling and root planing in subjects using a chlorhexidine rinse (0.12%) was significantly better than subjects using the placebo rinse as evidenced by less gingivitis (29%), fewer GI bleeding sites (48%) and less plaque (54%).

The clinical effects of a mouthrinse containing 0.1% octenidine.

The purpose of this three-month clinical trial was to evaluate the effects of a 0.1% octenidine mouthrinse on plaque, gingivitis, extrinsic dental stain, and the oral soft tissues. A total of 451 adult volunteer subjects was initiated into the study and given baseline dental examinations. The subjects were stratified into two balanced groups according to gender, plaque, and gingivitis scores. The subjects then received a dental prophylaxis and were provided with dentifrice, toothbrushes, and either a mouthrinse containing 0.1% octenidine dihydrochloride as the active ingredient or a similar placebo mouthrinse. Subjects were instructed to rinse with their assigned product for 30 s twice each day. Examinations were repeated at six weeks (soft-tissue assessment, gingivitis) and three months (soft tissues, plaque, gingivitis, dental stain). The results showed that the group rinsing with 0.1% octenidine had significantly less plaque (39%), gingivitis (50%), and bleeding sites (60%) than the group using the control product, but had significantly higher stain formation and experienced longer prophylaxis times to remove the stain. The oral soft-tissue examinations revealed no differences in the groups in either the numbers or types of lesions noted.

The relative plaque removal effect of a prebrushing mouthrinse.

A total of 51 adult subjects participated in a three-period crossover trial to test plaque-removal effectiveness of a prebrushing mouthrinse. Subjects refrained from brushing to allow plaque to accumulate for 24 hours before the test. The accumulated plaque was graded using Turesky's method. The subjects then used one of three treatment regimens, were retested for accumulated plaque and regraded. The three treatments tested were a commercial prebrushing mouthrinse and no toothbrushing; a commercial prebrushing mouthrinse and brushing with a dentifrice for 30 seconds; a prebrushing water rinse and brushing with a dentifrice for 30 seconds. The analysis of the data found that both groups that brushed removed significantly more plaque than the group that did not brush. However, both the prebrushing rinse group and the water rinse group achieved the same amount of plaque removal through 30 seconds of toothbrushing with a dentifrice.

A clinical evaluation of the relative cariostatic effect of dentifrices containing sodium fluoride or sodium monofluorophosphate.

A three-year clinical trial was conducted to determine whether a sodium fluoride (NaF) dentifrice had greater cariostatic effects than a sodium monofluorophosphate (Na2PO3F) dentifrice. Both dentifrices contained 1100 ppm fluoride and silica abrasive systems. A panel of 3,290 children, age 6-16, received one of the two dentifrices for ad libitum home use. The subjects were examined for caries at the baseline and after 2 and 3 years. Results were analyzed both for all children and for those children age 11 years or older at the baseline. The older children were found to have about 50 percent higher new caries increments than did the entire panel of children. In the older, caries- prone children, the subjects using the NaF product experienced significantly (15 percent and 12 percent) fewer new lesions than did the subjects using the Na2PO3F product after 2 and 3 years respectively. In the panel of all children, subjects using the NaF product had numerically, but not significantly, fewer new lesions. The results for this study, showing significantly greater cariostatic benefits in caries-prone children for a sodium fluoride dentifrice with a highly compatible system, are consistent with findings of other investigators.