Anticalculus effect of two zinc citrate/essential oil-containing dentifrices.

PURPOSE: To assess the feasibility of incorporating zinc citrate, a known anticalculus ingredient, into a dentifrice formulation containing a fixed combination of essential oils, a known antiplaque/antigingivitis agent. MATERIALS AND METHODS: This randomized, parallel, double-blind study evaluated the potential of two essential oil dentifrice formulations containing different levels of zinc citrate (1.0% and 2.0% ZCT) to reduce supragingival calculus formation compared to a marketed control dentifrice, Crest Regular. Following a 3-month pre-test phase, subjects received a dental prophylaxis, were stratified into three balanced groups on the basis of Volpe-Manhold calculus scores and brushed twice daily with their assigned dentifrice for 3 months. RESULTS: One hundred ninety-six evaluable subjects completed all phases of the study. ANCOVA revealed that the 1.0% ZCT and 2.0% ZCT essential oil dentifrice formulations provided significant reductions in calculus formation of 26.4% and 29.0% (P< 0.001), respectively, compared to the control dentifrice, Crest Regular. The magnitude of calculus reductions is similar to those levels obtained by other zinc salt formulations.

Caries inhibition efficacy of an antiplaque/antigingivitis dentifrice.

PURPOSE: To evaluate the efficacy of a fluoride dentifrice containing a fixed combination of essential oils (Thymol, Menthol, Eucalyptol, and Methyl Salicylate) in preventing caries in Sprague Dawley rats. MATERIALS AND METHODS: The dentifrice contains 0.76% sodium monofluorophosphate (SMFP) as the fluoride source and a silica abrasive system. A fluoride-free placebo and a clinically proven USP dentifrice reference standard for SMFP/silica were included as controls. Three groups of 45 SDV-free Sprague Dawley weanlings were infected by a cariogenic strain of Streptococcus sobrinus and fed cariogenic diet NIH 2000 ad libitum. Animals were treated twice daily (once on weekends) with the assigned dentifrice using a cotton-tipped applicator, for 5 wks, after which they were terminated and caries scored using Larson's modification of the Keyes method. RESULTS: Analyses of variance were used to compare inter-group means, the total E lesion score was the primary efficacy variable. Compared with the fluoride-free vehicle control, the experimental dentifrice and USP reference standard dentifrice produced a statistically significant reductions of 18.3% and 12.2% respectively for total caries score (P<0.001). Compared with the clinically tested USP positive control dentifrice, the experimental dentifrice produced a statistically significant reduction in the total caries score of 6.9% (P=0.028). The results of this study show that 1) both the new dentifrice containing essential oils and USP dentifrice are statistically significantly effective in reducing caries in the rat model, 2) the anticaries activity of the SMFP dentifrice is not adversely affected with the addition of essential oils.

Clinical effectiveness of essential oil-containing dentifrices in controlling oral malodor.

PURPOSE: To assess the efficacy of two essential oil-containing dentifrices in the reduction of human intrinsic oral malodor ("morning bad breath"). MATERIALS AND METHODS: Two clinical trials were conducted which used observer-blind, negative control, parallel designs. To insure a homogeneous test population with similar oral odor characteristics, subjects followed instructions that included toothbrushing with a standard ADA-accepted fluoride dentifrice the night before. On odor evaluation days, subjects refrained from all oral hygiene procedures and from eating or drinking any food or beverage or smoking prior to and during the odor evaluations. Eighty healthy adult subjects in the first trial and 90 in the second trial with qualifying baseline levels of oral malodor participated. Odor ratings of each subject's breath were made by 4-5 trained judges using a nine point hedonic scale, i.e., 1 = most pleasant, 5 = neutral, 9 = most unpleasant. Qualifying subjects were randomly assigned one of two essential oil dentifrices or a negative control dentifrice. Subjects brushed with their assigned dentifrice for 60 s, rinsed with 20 ml of water for 10 s, and received post-treatment hedonic odor ratings at 30, 60, 90, 120, 180, and 240 min. Data were analyzed using an ANCOVA to adjust for baseline scores. RESULTS: The essential oil dentifrices were significantly more effective (P < or = 0.033) than the control in reducing intrinsic oral malodor from 90 to 120 min.

Stain removal efficacy of two new fluoride dentifrices containing essential oils.

PURPOSE: To assess in vitro the stain removal efficacy of two new antiplaque/antigingivitis dentifrices utilizing a modification of a previously validated Stookey method. MATERIALS AND METHODS: The modifications to the original Stookey method are the following: (1) study design; three 5 x 5 Latin Squares were employed to minimize bias stemming from position or test run in the study. (2) statistical success criteria; a test formulation was judged to be effective if the lower one-sided 95% confidence limit was "equal to or higher than" 50 since a minimum PCR (pellicle cleaning ratio) score of 50 is needed for a dentifrice to show clinical efficacy. The two test dentifrice formulations contained a fluoride source, a silica abrasive system, and four essential oils. The ADA reference abrasive material (calcium pyrophosphate) and placebo toothpaste were included as positive and negative controls, respectively. RESULTS: Compared to the negative control, the positive control exhibited a statistically higher PCR score; therefore, the validity of this modified Stookey method was confirmed. Additionally, the lower limits of the one-sided 95% confidence interval for the two dentifrice formulations were above the threshold PCR of 50; therefore, this modified Stookey method should predict that both essential oil-containing dentifrices possess acceptable stain removal power.

Essential oils in an antiplaque and antigingivitis dentifrice: a 6-month study.

PURPOSE: To determine if a dentifrice formulated with the fixed combination of essential oils possessed antiplaque and antigingivitis properties. MATERIALS AND METHODS: This study was a blinded, randomized, controlled clinical trial. The 6-month study had clinical examinations at baseline, 3 and 6 months. The examinations consisted of three indices; a plaque index, the Modified Gingival Index and a bleeding index. RESULTS: At 6 months, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean plaque index scores exhibiting mean reductions of 18.3% and 18.1% relative to the vehicle control. At 6 months, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean gingival index scores compared to the vehicle control with reductions of 16.2% and 15.5%, respectively. Finally, for the gingival bleeding index, the essential oil-containing dentifrice group had statistically significantly (P < 0.001) lower whole-mouth and interproximal mean bleeding index scores and reductions of 40.5% and 46.9% at 6 months compared to the vehicle control.

Anticalculus efficacy of an essential oil dentifrice containing 1.3% pyrophosphate ion.

One-hundred and fifty (150) healthy adult subjects, who readily form dental calculus under normal brushing conditions, completed this study to determine the efficacy of an essential oil dentifrice formulation containing 1.3% pyrophosphate ion (PPi) in inhibiting the development of supragingival calculus, compared to a commercially available control dentifrice (Crest Regular). This study was conducted in two phases: an 8-week pre-trial phase (Phase I) to identify a suitable calculus forming population, and a 12-week trial phase (Phase II) utilizing a randomized, double-blind, parallel group design. Calculus scores from Phase I were used to form balanced groups for Phase II. At the start of Phase I, subjects received a thorough dental prophylaxis and were instructed to brush twice daily for 60 seconds with the control dentifrice. At 8 weeks, subjects were scored for calculus; subjects with a Volpe-Manhold Calculus Index score > or = 7.0 qualified to enter Phase II. Qualifying subjects were stratified by calculus scores and randomly assigned to one of two treatment groups. Subjects then received a baseline oral soft tissue examination and dental prophylaxis, and began twice-daily brushing with their assigned dentifrice for 12 weeks. At 12 weeks, subjects received an oral soft tissue examination and were re-scored for calculus. The 1.3% PPi dentifrice group mean score was statistically significantly different (p = 0.03) from the control dentifrice group mean score, producing a 14.1% calculus reduction. In this study the essential oil dentifrice containing 1.3% pyrophosphate ion was effective in inhibiting the development of supragingival calculus.

The prevalence of interdental gingival inflammation: a report from the 1986 ADA annual health screening.

This study screened 1986 ADA annual session participants for interdental gingival inflammation by using the Eastman Interdental Bleeding Index (EIBI). The EIBI provides a sensitive and objective measure of interdental gingival inflammation, and has been shown to be reliable. At least one bleeding site was found in 81% of the 435 dentists examined. This study showed that in a dental population, the prevalence of gingival inflammation was high when the health of interdental tissues was assessed.

The relative clinical effectiveness of three anticalculus dentifrices.

A three-month double-blind clinical study was conducted to compare the effect of three commercially available antitartar dentifrices in retarding the rate of supragingival calculus formation. After a thorough dental prophylaxis, the subjects were instructed to brush their teeth twice daily with either Prevent, Crest Tartar Control Formula (TCF), or Colgate TCF. Supragingival calculus accumulation on the mandibular anterior teeth was measured after 3 months use of the assigned dentifrice. The results of this study showed that Prevent retarded calculus formation 38.0% more than Crest TCF. Colgate TCF retarded calculus accumulation by 36.0% more than Crest TCF. No significant differences in anticalculus effectiveness were noted between Prevent and Colgate TCF.

Reduced formation of supragingival calculus with use of fluoride-zinc chloride dentifrice.

Results of this comparative, double-blind, clinical study show that fluoride dentifrice with 2.0% zinc chloride is effective in reducing calculus accumulation after a dental prophylaxis. The data also confirm earlier observations on calculus formation in that accumulation was not constant during the two 3-month study phases.