There is limited evidence from clinical trials on the dose response of sodium fluoride dentifrices at concentrations above 1100 ppm fluoride ion, with respect to caries efficacy. This randomized, double-blind study examined the anti-caries effectiveness of sodium fluoride dentifrices containing 1700 ppm, 2200 ppm and 2800 ppm fluoride ion relative to an 1100 ppm fluoride ion control. A population of 5439 elementary schoolchildren, aged 6-15 years, was recruited from an urban central Ohio area with a low fluoride content water supply (<0.3 ppm). Subjects were examined by visual-tactile and radiographic examination at baseline and after 1, 2, and 3 years of using the sodium fluoride dentifrices. Subjects were stratified according to gender, age and baseline DMFS scores derived from the visual-tactile baseline examination and randomly assigned to one of four treatment groups: 0.243% sodium fluoride (1100 ppm fluoride ion), 0.376% sodium fluoride (1700 ppm fluoride ion), 0.486% sodium fluoride (2200 ppm fluoride ion), and 0.619% sodium fluoride (2800 ppm fluoride ion). All products were formulated with the same fluoride compatible silica abrasive. Results after 1 year provided evidence of a positive sodium fluoride dose response. Compared to the 1100 ppm fluoride treatment group, the 1700 ppm fluoride treatment group had an 11.0% reduction in DMFS that was not statistically significant, while the 2200 ppm and 2800 ppm fluoride treatment groups showed statistically significant (P<0.05) reductions of 18.6% and 20.4%, respectively. The reductions in caries delivered by the higher fluoride dentifrices were present across all tooth surface types, but were most pronounced for occlusal surfaces. Results at years 2 and 3 were confounded by a concurrent fluoride rinse program, which involved portions of the study population. While the trends for the higher fluoride dentifrices observed at year 1 remained at years 2 and 3, the difference observed between treatments were substantially less and failed to reach statistical significance (P<0.05). Collectively, the data demonstrate that the 2200 ppm and the 2800 ppm fluoride treatments delivered statistically significantly greater caries efficacy than the 1100 ppm fluoride treatment. This large-scale clinical trial provides evidence of a positive statistically significant dose relationship between dental caries and sodium fluoride in a dentifrice at levels above 1100 ppm fluoride at year 1.
This study compared the clinical efficacy of three mouthrinses containing either 0.12% chlorhexidine, phenolic compounds, or sanguinarine, which were used unsupervised, in a placebo-controlled, double-blind study of 6 months' duration. The study was conducted according to ADA clinical guidelines for evaluation of antigingivitis agents and was completed by 481 adults. Following baseline exams and a prophylaxis, subjects were randomly divided into treatment groups matched for age, gender, and gingivitis severity, and were instructed to use the rinses in accordance with manufacturer's directions. Followup examinations evaluated supragingival plaque, gingivitis, and gingival bleeding. Compared to placebo at 6 months, the group rinsing with 0.12% chlorhexidine had significantly less gingivitis (31% reduction), gingival bleeding (39% reduction), and plaque (49% reduction) and was significantly better than any of the other treatment groups (P less than 0.05). Both the phenolic and sanguinarine groups showed moderate, yet significant, reductions in plaque compared to placebo (24% and 12% respectively) yet were significantly less effective than the 0.12% chlorhexidine rinse (P less than 0.05). However, neither the phenolic nor sanguinarine rinses were significantly different than placebo in their effects on gingivitis or gingival bleeding. These results support previous published results on the superiority of 0.12% chlorhexidine when used in conjunction with professional care and as an adjunct to routine oral hygiene practices.
A clinical study was conducted among 200 adult males and females to compare the intrusive gingival index (GI) for estimating gingivitis with the nonintrusive and only visually applied papillary-marginal-gingivitis index (PMGI). The GI examinations were performed by a senior examiner with long experience and a junior examiner, while the PMGI was graded by only a senior examiner with long experience. A 4th examiner was included for grading bleeding sites by gentle intrusion at the orifice of the gingival crevice. Following the baseline examination by all examiners, the subjects were randomly assigned to either a group that received an oral prophylaxis immediately or to a group that received an oral prophylaxis 6 weeks after the baseline. All subjects were regraded by all examiners 4 days after the 2nd group received a prophylaxis. This delayed prophylaxis design created a difference in the responses between treatment groups. Both the GI examiners and the PMGI examiner concluded there was significantly less gingivitis in the group receiving a prophylaxis second. There were also significantly fewer bleeding sites in the group receiving a prophylaxis second as determined by both GI examiners and the bleeding-sites examiner.
The purpose of the present study was to evaluate a clinical procedure for determining the proficiency of gingivitis examiners. After 4 examiner trainees were instructed by and participated in practice examination sessions with a senior examiner, the 5 examiners participated in a 2-group clinical study which employed appropriately timed-staggered dental prophylaxes to create a gingivitis treatment effect between the 2 groups. The 1st group received dental prophylaxes 30 days before the 2nd group. 10 days after the 2nd group had received dental prophylaxes, both groups were examined independently by all 5 examiners. Baseline examinations had been made on all subjects by all 5 examiners independently to serve as a covariable in the statistical analyses. During this clinical exercise, the examiners did not know at what time prophylaxes had been given nor did they have access to the previous examination records. The expected presence of a treatment effect, as confirmed by the senior examiner, was found by all of the examiner trainees in this exercise. The treatment effect for all examiners was statistically significant.
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