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 the efficacy of the procedure. 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 product will be actively applied to the labial surfaces of the anterior teeth for 10 minutes. Following this, 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, adopting a 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 post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain. This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session. The assessment form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient's pain intensity level.

  14 days

Secondary Outcomes (1)

• Color evaluation

  Baseline (T0) and one week after the 2rd whitening session (T1)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The Placebo group received the application of placebo gel for post tooth bleaching sensitivity.

Other: Placebo

KF2 - Potassium nitrate

ACTIVE COMPARATOR

The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.

Other: KF2 - Potassium nitrate

Jucá - Libidibia ferrea gel

EXPERIMENTAL

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

Other: Jucá - Libidibia ferrea gel

Interventions

Placebo OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the Placebo group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.

Placebo

KF2 - Potassium nitrate OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 group will received the application of the potassium nitrate gel on the labial surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.

KF2 - Potassium nitrate

Jucá - Libidibia ferrea gel OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Jucá group will received the application of the Libidibia ferrea 0.5% experimental gel on the labial surfaces of the central incisors, lateral incisors, canines and upper and lower 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
• never having previous whitening therapy
• not present dental hypersensitivity
• not be pregnant
• present at least 28 teeth in the oral cavity.

You may not qualify if:

• volunteers who were under orthodontic treatment,
• presence of periodontal disease
• dental cracks or fractures
• restorations and prostheses on anterior teeth
• extensive molar restorations
• gastroesophageal disorders
• severe internal dental darkening
• presence of dentinal 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 (Estimated): June 13, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)