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

NCT07599514 | Not Yet Recruiting

• 1 other identifier: 95040526.4.0000.0018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Tooth Bleaching; Pain; Dentin Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Post-whitening sensitivity assessment

  To assess postoperative sensitivity, patients will be instructed to complete a form to record daily tooth sensitivity during the 14-day treatment period, based on their individual perception of pain. This form will be provided at each bleaching session and returned to the researcher at the following session, that is, one week after each bleaching session. The assessment form will include a visual analog scale (VAS), consisting of a 10-cm horizontal line with scores of 0 and 10 at its ends, where 0 indicates no sensitivity and 10 indicates severe tooth sensitivity. Patients will be instructed to draw a vertical mark along the horizontal line of the scale to record the intensity of tooth sensitivity each day. Subsequently, the distance in millimeters from the zero endpoint will be measured using a millimeter ruler, thereby obtaining the patient's pain intensity score.

  14 days

Secondary Outcomes (1)

• Color evaluation

  Baseline (T0) and one week after the second bleaching session (T1)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity.

Other: Placebo

KF2 - Potassium nitrate

ACTIVE COMPARATOR

The KF2 group received an application of 5% potassium nitrate and 2% sodium fluoride for the control of post-bleaching tooth sensitivity.

Other: KF2 - Potassium nitrate

Jucá - Libidibia ferrea gel

EXPERIMENTAL

The Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity.

Other: Jucá - Libidibia ferrea gel

Interventions

Placebo OTHER

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.

Placebo

KF2 - Potassium nitrate OTHER

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.

KF2 - Potassium nitrate

Jucá - Libidibia ferrea gel OTHER

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.

Jucá - Libidibia ferrea gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene; Absence of active caries lesions; No previous tooth bleaching treatment; Absence of dental hypersensitivity; Not being pregnant; Presence of at least 28 teeth in the oral cavity.

You may not qualify if:

• Volunteers undergoing orthodontic treatment; Presence of periodontal disease; Dental cracks or fractures; Restorations or prostheses on anterior teeth; Extensive restorations in molars; Gastroesophageal disorders; Severe intrinsic tooth discoloration; Presence of dentin exposure in anterior and/or posterior teeth.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

UFPA

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cecy M Silva

CONTACT

+55 (91) 3201-7563; cecymsilva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Graduate Program in Dentistry at the Federal University of Pará

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: June 13, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)