Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial

Abstract

Objectives: To evaluate the efficacy of a gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to professional plaque removal on desquamative gingivitis (DG). Materials and methods: A randomized clinical trial was conducted on patients suffering DG due to mucocutaneous diseases. Patients received professional supragingival prophylaxis with oral hygiene instructions and were randomly assigned to use test or control gels as toothpaste and to apply it on DG lesions 3 times/day for 4 weeks. DG clinical score (DGCS), clinical periodontal variables, and visual analog scale (VAS) for pain and oral health impact profile (OHIP-14) were collected at baseline, 2 and 4 weeks. Results: Twenty-two patients were randomly assigned to test (n = 11) or control group (n = 11). Eighteen had diagnosis of oral lichen planus and four of mucous membrane pemphigoid. DGCS statistically decreased in both groups after treatment with no significant differences between groups. Clinical periodontal outcomes decreased in both groups, but no significant differences were observed. Periodontal variables statistically improved only in test group after treatment. VAS and OHIP-14 scores decreased in test and control groups without significant differences. However, only one test group showed a statistically significant decrease in VAS and OHIP-14 scores after treatment. No adverse effects were reported. Conclusions: Test gel may alleviate DG and improve quality of life without side effects. Clinical relevance: A gel-containing propolis extract, nanovitamin C, and nanovitamin E as adjuvants to mechanical debridement may improve both clinical and patient related outcomes in DG patients without side effects. Clinical trial registration. The study protocol was registered at clinicaltrials.gov with the following number: NCT05124366 on October 16, 2021.