Introduction Plaque 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 analysis In 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 dissemination The 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 number ChiCTR2000041253.
- oral & maxillofacial surgery
- protocols & guidelines
- clinical trials
- oral medicine
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JL and YH contributed equally.
Contributors XO is the PI of this project and was responsible for designing and supervising the trial. JL is in charge of participant recruitment and oral examinations. YH is involved in supragingival scaling, data collection and analysis. BL is involved in participant recruitment, data collection and analysis. NA is in charge of participant recruitment. RW is in charge of patient appointment and data record. XL is responsible for breath testing and correspondence with the ethics committee. WL is in charge of the sample size calculations, mouthwash preparation, allocation and randomisation.
Funding This study was sponsored by Jiangsu Pudilan Daily Chemical Company. The company provided the research funds, Pudilan Keyanning antibacterial mouthwash, toothpaste, toothbrushes and other materials required for the study.
Disclaimer The company was not involved in the design, operation, data acquisition and analysis.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.