Article Text

Download PDFPDF

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
  1. Jianru Liu1,
  2. Yan Huang1,
  3. Xinzhe Lou1,
  4. Bei Liu1,
  5. Wenyi Liu1,
  6. Na An2,
  7. Rong Wu1,
  8. Xiangying Ouyang1
  1. 1Department of Periodontology, Peking University, School of Stomatology, Beijing, China
  2. 2Department of General Dentistry II, Peking University, School of Stomatology, Beijing, China
  1. Correspondence to Professor Xiangying Ouyang; kqouyangxy{at}


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

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


  • 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.