Effects of toothbrushes with tapered and cross angled soft bristle design on dental plaque and gingival inflammation: A randomized and controlled clinical trial

Objective: The aim of this study was to compare the effects of typified propolis and chlorhexidine mouthrinses on gingival health in a randomized double-masked placebo-controlled clinical trial.Methods: Sixty participants were randomized to 3 mouthrinse study groups: 1) 2% typified propolis (n=20); 2) 0.12% chlorhexidine (n=20), and 3) placebo (n=20). Participants rinsed unsupervised twice a day for 28 days. The Papillary Bleeding Score (PBS) was measured on the mesio-buccal surfaces of all teeth at baseline and 28 days thereafter. Co-variance analysis was employed to compare PBS average values and the number of sites with PBS ≥2 among study groups. Sub-group analysis was further applied to participants who were <40 years-old.Results: The results show efficacy of propolis mouthrinse when comparing before and after treatment protocols significantly for a reduction of mean PBS scores. When looking at younger participants after 28 days, propolis mouthrinse was superior to all groups in reducing mean PBS scores and significantly so when compared to 0.12% chlorhexidine mouthrinse.Conclusion: The efficacy of 2% typified propolis mouthrinse was demonstrated in reducing the levels of gingival inflammation. These results need to be duplicated by other investigators by employing similar study protocols.Descriptors: Randomized Clinical Trial, Propolis, Chlorhexidine, Gingivitis

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Effect of Pudilan Keyanning antibacterial mouthwash on dental plaque and gingival inflammation in patients during periodontal maintenance phase: study protocol for double-blind, randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2021-048992 ◽

2021 ◽

Vol 11 (11) ◽

pp. e048992

Author(s):

Jianru Liu ◽

Yan Huang ◽

Xinzhe Lou ◽

Bei Liu ◽

Wenyi Liu ◽

...

Keyword(s):

Clinical Trial ◽

Study Protocol ◽

Dental Plaque ◽

Critical Role ◽

Maintenance Phase ◽

Controlled Clinical Trial ◽

Double Blind ◽

Periodontal Inflammation ◽

Plaque Control ◽

Periodontal Maintenance

IntroductionPlaque control plays a critical role in the prevention and treatment of periodontitis. Antibacterial mouthwash is one of the most important tools for plaque control. Pudilan, including extracts of Scutellaria baicalensis root, Taraxacum mongolicum, Bunge corydalis herb and Isatis indigotica, was reported playing the role of anti-inflammatory and anti-bacterial. However, its effect on dental plaque and periodontal inflammation remains unknown. We aimed to assess the efficacy of Pudilan Keyanning antibacterial mouthwash which contains the active essence of Pudilan and 0.03%–0.06% cetylpyridinium chloride, as well as Pudilan active essence for plaque control and gingival anti-inflammation in patients during periodontal maintenance phase.Methods and analysisIn this double-blind, randomised, placebo-controlled clinical trial, a total of 120 participants during periodontal maintenance phase will be enrolled. After supragingival scaling, they will be randomly assigned into three groups in a 1:1:1 ratio: the Pudilan Keyanning antibacterial mouthwash group, a chlorhexidine acetate mouthwash (0.12%) group or a placebo group with mouthwash containing the same components as the Pudilan Keyanning mouthwash except for Pudilan active ingredients. They will rinse with mouthwash, respectively, two times per day for 6 weeks. Clinical parameters (such as plaque index, bleeding index) and the level of volatile sulfide in the breath will be measured and analysed. The subgingival plaque will be collected and analysed microbiologically. Questionnaire feedback will be analysed.Ethics and disseminationThe study protocol (V.4) was reviewed and approved by the Medical Ethical Committee of Peking University School and Hospital of Stomatology (Ethics Approval No. PKUSSIRB-201950153b). All participants signed a written consent form.Trial registration numberChiCTR2000041253.

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