Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial.

BACKGROUND: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. METHOD: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. RESULTS: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated < 10% of bleeding sites. CONCLUSION: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of "clinical periodontal health" (< 10%) following a dental prophylaxis and 24 weeks of product use. TRIAL REGISTRATION: This study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

Prevention of lingual calculus formation with daily use of 6% H2O2/2% pyrophosphate whitening strips.

OBJECTIVE: This randomized controlled clinical trial was conducted to evaluate whether daily use of a hydrogen peroxide/ pyrophosphate-containing antitartar whitening strip might safely yield clinical reductions in post-prophylaxis calculus accumulation. METHODS: A three-month, randomized controlled trial was conducted to compare calculus accumulation with a daily 6% hydrogen peroxide/pyrophosphate strip versus regular brushing. After an eight-week run-in phase to identify calculus formers, a prophylaxis was administered, and 77 subjects were randomly assigned to daily strip or brushing only groups. All subjects received an anticavity dentifrice (Crest Cavity Protection) and manual brush for use throughout the three-month study; for subjects assigned to the experimental group, strip application was once daily for five minutes on the facial and lingual surfaces of the mandibular teeth. Efficacy was measured as mm calculus (VMI) before prophylaxis and after six and 12 weeks of treatment, while safety was assessed from examination and interview. RESULTS: Subjects ranged in age from 21-87 years, with groups balanced (p > 0.26) on pertinent demographic and behavioral parameters, and pre-prophylaxis calculus baseline mean scores (16.0 mm). At Week 6, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 12.0 (0.87) for the strip group and 17.0 (0.88) for the brushing control. At Week 12, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 14.3 (0.85) for the strip group and 17.2 (0.86) for the brushing control. Treatments differed significantly (p < 0.02) on calculus accumulation at both time points. A total of three subjects (8%) in the strip group and two subjects (5%) in the brushing control had mild oral irritation or tooth sensitivity during treatment; no one discontinued early due to an adverse event. CONCLUSION: Daily use of hydrogen peroxide whitening strips with pyrophosphate reduced calculus formation by up to 29% versus regular brushing, without meaningful adverse events.

An evaluation of sodium bicarbonate chewing gum in reducing dental plaque and gingivitis in conjunction with regular toothbrushing.

The purpose of the present study was to determine the ability of a chewing gum containing 5% sodium bicarbonate to remove dental plaque and reduce gingivitis when used as a supplement to daily toothbrushing. The study group consisted of 88 adults with moderate gingivitis. Participants were divided into 4 groups and instructed to chew the study gum 0 (control), 1, 2, or 3 times daily for 1 month in addition to regular daily toothbrushing. Chewing sodium bicarbonate-containing gum significantly (P < .05) reduced plaque after 1 week, with progressively greater reductions occurring after 2 and 4 weeks of gum chewing. No correlation was observed between plaque reduction and the number of times per day that the gum was chewed. By week 4, plaque reduction of approximately 16% was achieved in all groups using the gum as compared with the control group. Reductions in gingivitis were observed in all participants who chewed the gum, and these reductions achieved statistical significance by week 4. Slightly greater improvements in gingivitis were achieved in participants who chewed the gum 2 or 3 times daily as compared with the control group and those who chewed the gum once daily. No adverse effects on the oral tissues were observed in any of the participants for the duration of the study. In conclusion, regular use of a chewing gum containing 5% sodium bicarbonate appears safe and effective for the removal of dental plaque and reduction of gingivitis when used in conjunction with daily toothbrushing.

A split-mouth comparison of a three-dimensional-action electric toothbrush and a high-frequency electric toothbrush for reducing plaque and gingivitis.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of an electric toothbrush with three-dimensional (oscillating/rotating/pulsating) brush head action, Braun Oral-B 3D Plaque Remover, and an electric toothbrush with high-frequency vibrating action, Sonicare Plus. MATERIALS AND METHODS: This was a randomised, split-mouth study of 33 adult subjects who used both electric toothbrushes for a total of 9 weeks. After a 2-week acclimation period of brushing with each device on alternating days, subjects received a prophylaxis, then refrained from any oral hygiene on the mandibular teeth for 21 days to induce gingivitis. However, they continued to brush the maxillary teeth on alternating days with each electric toothbrush. Then, for a period of 4 weeks they brushed each side of the mouth with different toothbrushes, randomly assigned to right or left. Plaque and gingivitis were assessed initially, after the 21-day no-oral-hygiene period, and after 2, 3 and 4 weeks of brushing twice daily. RESULTS: After 21 days without oral hygiene, mean mandibular plaque and gingivitis scores increased significantly for all subjects. Use of both electric toothbrushes during the treatment phase progressively reduced plaque and gingivitis scores at each successive examination. The Braun toothbrush was significantly more effective than the Sonicare toothbrush in reducing plaque at every examination and gingival bleeding after 4 weeks of brushing. It is concluded that the Braun electric toothbrush with three-dimensional brush head action offers advantages over the Sonicare electric toothbrush with high-frequency vibrating action in terms of plaque control and potential improvement of gingival health following induction of experimental gingivitis.

A 3-month clinical comparison of the safety and efficacy of two battery-operated toothbrushes: the Braun Oral-B Battery toothbrush and the Colgate Actibrush.

PURPOSE: To compare the safety and efficacy of two battery-operated, non-rechargeable power toothbrushes, the Braun Oral-B Battery toothbrush (D4) and the Colgate Actibrush. MATERIALS AND METHODS: This was a randomized, single-blind, parallel-group study carried out over a 3-month period. A total of 114 subjects from a general population, who met the inclusion criteria of the study and who had whole mouth plaque scores of > or = 1.5 and gingivitis scores of > or = 1.2, participated in the study. Subjects were given either the D4 or the Colgate Actibrush with the manufacturers' instructions, and were asked to brush their teeth at home twice each day. At baseline and after 1 and 3 months, subjects were examined for oral hard and soft tissue health, after which they were assessed for gingivitis (Modified Gingival Index), bleeding (Gingival Bleeding Index), and plaque (Modified Quigley-Hein Plaque Index). Prior to each assessment, subjects refrained from all oral hygiene procedures for a period of 12-18 hours. RESULTS: No evidence was found of significant oral soft or hard tissue trauma, and both brushes were considered to be safe when used according to the manufacturers' instructions. In the D4 group, whole mouth, marginal and approximal plaque scores were significantly reduced from baseline (P < 0.05) after both 1 and 3 months by 7-12%, whereas, in the Actibrush group, plaque scores remained relatively unchanged from baseline throughout the study. Furthermore, comparisons between the toothbrush groups showed that whole mouth, marginal and approximal plaque scores for the D4 were significantly lower than those for the Actibrush at both the 1- and 3-month assessments. Modified Gingival Index scores after 3 months were significantly reduced from baseline in both groups by 7-8%. Similarly, percentages of bleeding sites were significantly lower by 12-15%. There were no significant differences between the groups with respect to gingivitis scores.

Treatment of orthodontic white spot lesions with a remineralizing dentifrice applied by toothbrushing or mouth trays.

This pilot study investigated the effect of a remineralizing fluoride dentifrice (Enamelon) on newly formed incipient carious lesions using two methods of application. Teenage orthodontic patients with obvious white spot lesions on their teeth were selected to begin treatment within 30 days after debanding. At baseline, the surface enamel of the test teeth was cleaned by air etching with 50 microns alumina at 150 psi. Lesion size (mm2) was measured using a calibrated periodontal probe and surface appearance was quantified as shiny (0), dull (1), or chalky (2). Twice daily for 3 months, one group with a total of 27 lesions brushed with the remineralizing dentifrice, while a second group with 41 total lesions brushed and used a mouth tray to apply the paste directly to the lesions for 5 min. In order to promote treatment compliance, test group assignment was based on subject and parental preference. After 1, 2, and 3 months, lesion size was reduced by 5% (ns), 10% (p < 0.05) and 22% (p < 0.01), respectively, for the brushing group, and 16% (p < 0.05), 37% (p < 0.01) and 30% (p < 0.01) for the combined brushing and tray group, respectively. The dull appearance of the lesions treated by brushing improved slightly over 3 months. However, the lesions receiving combined brushing and tray applications became significantly (p < 0.01) less dull by 28%, 44% and 61% after 1, 2, and 3 months, respectively, indicating the formation of a shiny, intact surface layer. In conclusion, brushing with a remineralizing dentifrice significantly reduced the size of new orthodontic white spots within 2 months, while brushing combined with topical tray applications reduced lesion size within 1 month with concomitant formation of a shiny enamel surface layer. Thus, the combined brushing and mouth tray treatment significantly accelerated the remineralization process.

Evaluation of a dental floss containing soluble pyrophosphate on calculus formation using a short-term clinical model.

This clinical study compared the effect of a dental floss containing 0.25 mg tetrasodium pyrophosphate per cm and a placebo floss on supragingival calculus formation using a 6-week, partial-mouth toothshield model. The six lower anterior teeth were scaled and polished before each 2-week period (i.e., pre-trial, washout, trial). During both the pre-trial and trial periods, subjects brushed twice daily with a non-tartar control dentifrice, while a toothshield protected the six test teeth from brushing. After rinsing with water and removing the shield, they flossed the test teeth. All subjects used placebo floss during the pre-trial period in order to determine the baseline Volpe-Manhold Index (VMI) calculus formation scores, which were used to balance groups for the trial period. During the trial period, one group used the placebo floss, while the second group used the pyrophosphate floss. The final results demonstrated that the pyrophosphate floss significantly inhibited calculus formation between teeth (mesial-distal scores) by 21%, and on labial surfaces by 37% relative to the placebo floss.