Clinical Performance Evaluation of a Hyaluronic Acid Dental Gel for the Treatment of Traumatic Ulcers in Patients with Fixed Orthodontic Appliances: A Randomized Controlled Trial

Abstract

Background: A newly available gel containing hyaluronic acid (HA) and polyvinylpyrrolidone was tested for efficacy on traumatic oral ulcers (TOU) caused by fixed orthodontic appliances. Methods: A double-blind RCT was conducted to test the new gel versus a placebo. According to the sample size calculation, a total of 60 patients were considered sufficient and randomly allocated to one of the two groups out of a pool of 100 total patients who initially agreed to participate in the study. A VAS scale test and lesion measurements at T0, T1, and T2 were performed on the patients. Results: A total of 70 patients developed TOU, with 8 drop-outs; the intergroup comparison showed a statistically significant greater dimension of the lesion in the control group at T2 when compared to the test group. The pain experienced by the patients belonging to the test group was significantly lower than the pain in the patients in the control group Conclusions: Under the limitations of the study, the new formula might provide faster healing with less pain experienced by the patient when compared to a placebo.