Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Liu J

PROVIDER: S-EPMC8565561 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDental plaque is a global health problem affecting people of various age groups. Cannabinoids are gaining enormous research attention due to its beneficial properties for various applications. A preliminary observation on antimicrobial property of cannabinoids against dental plaque bacteria has been reported recently. As a follow-up research, here we report the in vitro evaluation of cannabinoids infused mouthwash products against total culturable (aerobic) bacterial content from dental plaque samples.MethodsWe tested two cannabinoid-infused mouthwash products containing cannabidiol (CBD) and cannabigerol (CBG) respectively (each mouthwash containing < 1% cannabinoid by weight) in vitro against total-culturable bacteria from dental plaque samples collected from 72 adults aged between 18 and 83 years. The participants were grouped on the basis of Dutch periodontal screening index (DPSI) score. To compare the efficacy of our products, we included two most commonly available products over the counter (Product A and Product B) to represent commercially available mouthwash products and the gold standard chlorhexidine digluconate 0.2% as a positive control. The product A represents mouthwash containing essential oils and alcohol, and Product B represents alcohol-free mouthwash that contains fluoride. All the mouthwash products were evaluated directly as such without any dilution through disc diffusion and agar well diffusion approaches and the diameter of zone of inhibition was measured. The limitation in methodology was that, the samples were open-label and the person who performed the manual measurements was unblind to test and control products used.ResultsOn average, the cannabinoids infused mouthwash products showed the similar bactericidal efficacy as that of chlorhexidine 0.2%. Both chlorhexidine 0.2% and cannabinoids infused mouthwash products were effective against all the samples tested. Product A did not show any significant antimicrobial activity in any of the samples tested, except that a very marginal inhibition with a zone of 7-8 mm was observed only in 9 samples. Product B did not show any detectable inhibition zone at all in any of the samples tested. The ranges of zones of inhibition (and their average) were 8-25 mm (18.1 mm) for CBD-mouthwash, 8-25 mm (17.7 mm) for CBG-mouthwash; 12-25 mm (16.8 mm) for chlorhexidine 0.2%; 0-8 mm (0.1 mm) for Product A; and 0 mm for Product B. Although the difference in performance was slightly higher than chlorhexidine in both the cases, the difference was statistically significant for CBD-mouthwash and near significant for CBG-mouthwash. No significant difference was observed between CBD- and CBG-mouthwash. No significant difference in performance was found between DPSI score groups for any of the product tested. To our knowledge this is the first report on such efficient mouthwash product with natural key ingredients including cannabinoids and without any kind of fluoride or alcohol.ConclusionsOur in vitro results demonstrate the potential of cannabinoids in developing efficient and safer mouthwash products and next generation oral care products without fluoride and alcohol.