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Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity
Sponsor: Universidade Federal do Para
Summary
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%.
Official title: Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-06-13
Completion Date
2027-03-30
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
Placebo
Before bleaching treatment with 35% hydrogen peroxide, participants in the placebo group received a placebo gel without active ingredients, applied under the same conditions described for the experimental gel.
KF2 - Potassium nitrate
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the KF2 group will receive an application of a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
Jucá - Libidibia ferrea gel
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the Jucá group will receive an application of the experimental 0.5% Libidibia ferrea gel on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
Locations (1)
UFPA
Belém, Pará, Brazil