Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity

This randomized, parallel, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy. Seventy-five selected volunteers will be randomly allocated into three groups: CT (placebo gel), KF2 (5% potassium nitrate and 2% sodium fluoride), and JUC (experimental Libidibia ferrea gel). Each group will receive the corresponding desensitizing treatment, and the assigned product will be actively applied to the labial surfaces of the anterior teeth and the buccal surfaces of the first premolars for 10 minutes. Subsequently, all groups will undergo an in-office tooth bleaching protocol with 35% hydrogen peroxide, consisting of two sessions with three 15-minute applications each, with a 7-day interval between sessions. Postoperative sensitivity will be recorded daily by the patients for 14 days using a visual analog scale (VAS), while tooth color will be measured using a spectrophotometer at baseline and one week after the end of treatment. Data will be subjected to statistical analysis according to sample distribution, with a statistical power of 80% and a significance level of 5%.

NCT Number	NCT07599514
Lead Sponsor	Universidade Federal do Para
Conditions	Tooth Bleaching, Pain, Dentin Desensitizing Agents
Enrollment	75 participants
Start Date	2026-06-13
Primary Completion	2027-01-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-22