Dataset Information

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

ABSTRACT:

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??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 2 treatment group demonstrated ConclusionA 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" (Trial registrationThis study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

SUBMITTER: Parkinson CR

PROVIDER: S-EPMC7098169 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Parkinson C R CR Milleman K R KR Milleman J L JL

BMC oral health 20200326 1

<h4>Background</h4>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, fol ...[more]

PMID: 32216778

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Project description:ObjectiveTo test the efficacy of a dentifrice containing baking soda (BS), compared with dentifrice without BS for controlling plaque and gingivitis.Materials and methodsMEDLINE-PubMed and Cochrane-CENTRAL were searched. The inclusion criteria were randomized controlled clinical trials including healthy participants aged 18 years or older. Studies were selected that compared the effect of toothbrushing with a dentifrice with and without BS on the clinical parameters of plaque and gingivitis. Data were extracted from the selected studies, and a meta-analysis was performed.ResultsThe search retrieved 21 eligible publications. Among these papers, 43 comparisons were provided, with 23 involving a single-use design and 20 being evaluations with a follow-up. Negative controls were found, or positive controls for which various active ingredients had been used. The included studies showed a moderate overall potential risk of bias and considerable heterogeneity. The meta-analysis of plaque scores from the single-brushing experiments showed that BS dentifrice (BS-DF) was associated with significantly better outcomes than the negative control dentifrices (DiffM -0.20; P < 0.0001; 95% CI: [-0.27; -0.12]) or the positive control dentifrices (DiffM -0.18; P < 0.0001; 95% CI: [-0.24; -0.12]). This finding was only confirmed in studies that used a follow-up design as compared to a negative control (DiffM -0.19; P = 0.01; 95% CI: [-0.34; -0.04]). The indices of gingival bleeding also improved when the comparison was a negative control (DiffM -0.08; P = 0.02; 95% CI: [-0.16; -0.01] and (DiffM -0.13; P < 0.001; 95% CI: [-0.18; -0.08]. However, for the gingival index scores, the meta-analysis did not reveal any significant differences.ConclusionBS-DF showed promising results with respect to plaque removal in single-use studies. However, the finding was partially substantiated in follow-up studies. Studies that assessed bleeding scores indicated that a small reduction can be expected from BS, relative to a control product.

Project description:OBJECTIVES: Linaclotide is a minimally absorbed guanylate cyclase-C agonist. The objective of this trial was to determine the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). METHODS: This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period. There were four primary end points, the Food and Drug Administration ’ s (FDA ’ s) primary end point for IBS-C (responder: improvement of ≥ 30 % in average daily worst abdominal pain score and increase by ≥ 1 complete spontaneous bowel movement (CSBM) from baseline (same week) for at least 50 % of weeks assessed) and three other primary end points, based on improvements in abdominal pain and CSBMs for 9 / 12 weeks. Adverse events (AEs) were monitored. RESULTS: The trial evaluated 800 patients (mean age = 43.5 years, female = 90.5 % , white = 76.9 % ). The FDA end point was met by 136 / 405 linaclotide-treated patients (33.6 % ), compared with 83 / 395 placebo-treated patients (21.0 % ) ( P < 0.0001) (number needed to treat: 8.0, 95 % confidence interval: 5.4, 15.5). A greater percentage of linaclotide patients, compared with placebo patients, reported for at least 6 / 12 treatment period weeks, a reduction of ≥ 30 % in abdominal pain (50.1 vs. 37.5 % , P = 0.0003) and an increase of ≥ 1 CSBM from baseline (48.6 vs. 29.6 % , P < 0.0001). A greater percentage of linaclotide patients vs. placebo patients were also responders for the other three primary end points ( P < 0.05). Significantly greater improvements were seen in linaclotide vs. placebo patients for all secondary end points ( P < 0.001). During the RW period, patients remaining on linaclotide showed sustained improvement; patients re-randomized from linaclotide to placebo showed return of symptoms, but without worsening of symptoms relative to baseline. Diarrhea, the most common AE, resulted in discontinuation of 5.7 % of linaclotide and 0.3 % of placebo patients. CONCLUSIONS: Linaclotide significantly improved abdominal pain and bowel symptoms associated with IBS-C for at least 12 weeks; there was no worsening of symptoms compared with baseline following cessation of linaclotide during the RW period.

Dataset Information

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

Background

Method

Results

Publications

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

Similar Datasets

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