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NCT Number: NCT07599514

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%.

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Key information

Conditions

Tooth Bleaching Dentin Desensitizing Agents Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

All groups will undergo in-office tooth bleaching treatment, performed in two sessions with a 7-day interval, according to the steps described below: prophylaxis; application of the desensitizing agent or placebo, according to the assigned group, for 10 minutes; rinsing with water; application of the gingival barrier; application of Whiteness HP 35% bleaching gel for 45 minutes, consisting of three 15-minute applications; final removal of the bleaching gel and gingival barrier, followed by rinsing with water. A lip retractor will be used during the application of the desensitizing agent or placebo and throughout the bleaching procedure. The assigned product will be actively applied using a microbrush.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Post-whitening sensitivity assessment

    Time frame: 14 days

    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.

Secondary outcomes

  1. Color evaluation

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

    The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used for color measurement. The evaluated tooth area will be the middle third of the labial surface of the maxillary canines. To standardize color readings, silicone matrices will be fabricated, with the impression extending from canine to canine. A window will be created on the labial surface of each canine in the silicone guide using a metal device with a 6-mm diameter, corresponding to the diameter of the spectrophotometer tip. Thus, the tip of the device will be inserted into the silicone guide to obtain the color parameters. Subsequently, the color difference between baseline (T0) and one week after the second bleaching session (T1) will be calculated using the CIEDE2000 formula (ΔE00).

Study contacts

Contact information is provided by the study sponsor or research team.

Cecy M Silva

CONTACT

[email protected]

+55 (91) 3201-7563

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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