Effect of gluma® on the oral health-related quality of life in patients with dentine hypersensitivity: a triple-blind, randomized, controlled clinical trial

Abstract

This study aimed to evaluate the impact of Gluma ® treatment on the oral health-related quality of life of patients with dentine hypersensitivity (DH). Adult participants with DH in more than one tooth were included. They were randomized into two groups: Gluma ® or control (saline solution). Block randomization was performed by computer and remained electronically hidden until the time of treatment. Gluma ® was applied to the dried and clean cervical area of the tooth with DH and maintained for 3 min; afterward, the material was removed. The control followed the same application protocol. To assess oral health-related quality of life, all participants completed the DHEQ-15 questionnaire at baseline and 30 days post-treatment. DH was assessed using tactile and air-jet tests at baseline and 30 days post-treatment, using a numerical pain scale. Data were subjected to the Wilcoxon, Mann-Whitney, and X 2 tests and Spearman’s correlation. The significance level was set at p < 0.05. The sample consisted of 147 (77.8%) women and 42 (22.2%) men, with a mean age of 31 years. There was a significant reduction in pain level ( p < 0.001) and in DHEQ-15 scores ( p < 0.001) after treatment with Gluma ® . In the placebo group, there was no significant difference in pain level ( p > 0.05) or in the DHEQ-15 score ( p > 0.05). There was a moderate positive correlation between the DHEQ-15 domains and the level of pain measured by tactile stimulation and air-jet in both groups. The desensitizing agent Gluma ® can improve oral health-related quality of life. This study was prospectively registered on the Brazilian Registry of Clinical Trials (ReBEC) platform, under the identifier RBR-9fmjf77 ( https://ensaiosclinicos.gov.br/rg/RBR-9fmjf77 ), prior to participant recruitment. Date of registration: March 31, 2024.