Evaluation of In-office Bleaching-induced Sensitivity With 2 or 7 Days Interval Between Sessions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Clinical randomized single-blind trial, used to measure the level of tooth sensitivity (TS) after in-office dental bleaching sessions, on volunteers using a modified visual analog scale (VAS). The investigators selected for this study, 47 participants with color 2M2 or darker (Using 0M1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with an acidic 35% hydrogen peroxide gel with either a 1-week or 2-day interval. The investigators recorded the TS up to 48 h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The risk and intensity of TS and the color change were compared between the two groups.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening

NCT03019224

Tooth Whitening Sensitivity

COMPLETED PHASE4

Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening

NCT05309967

Dentin Sensitivity

COMPLETED NA

Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change

NCT03514290

Tooth Bleaching Low-level Laser Therapy Dentin Sensitivity +1 more

COMPLETED NA

Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial

NCT02067715

Tooth Discoloration

COMPLETED NA

IN-OFFICE TOOTH BLEACHING WITH 37% CARBAMIDE PEROXIDE

NCT02935114

Tooth Sensitivity

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Two weeks before the bleaching procedures, selected volunteers from the city of Nova Friburgo, (Rio de Janeiro, Brazil) received a dental screening and a dental prophylaxis with pumice and water in a rubber cup and signed an informed consent form.

This was a randomized, single-blind (evaluators), parallel and equivalence trial with an equal allocation rate between groups.

A total of 61 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria. A total of 47 participants were included in this study. The participants were randomly divided in the 2-day and 7-day groups.

During the in-office sessions, participants had the gingival tissue isolated of the teeth using a light-cured resin dam (Top Dam, FGM, Joinville, SC, Brazil). After that, a 2% Potassium nitrate and Sodium fluoride desensitizer gel (Desensitize 2%, FGM) was applied for 15 minutes before dental bleaching. This gel was removed and the 35% hydrogen peroxide gel (Whiteness HP, FGM, Joinville, Brazil) was applied in three 15-min applications according to the manufacturer's directions in all upper and lower incisors, canines and premolars. After 2 days (2-day group) and 7 days (7-day group), this procedure was repeated using the same protocol.

Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective (value oriented shade guide Vita Lumin, Vita Zahnfabrik, Bad Sackingen, Germany) and an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). Color evaluation was done in a room under artificial lightning conditions without interference from outside light.

For the subjective examination, the shadeguide's 16 tabs were arranged from highest (B1) to lowest (C4) value. Changes in the scale were treated as representing a continuous and approximately linear ranking. Color was measured in the middle third of the facial surface of the right upper canine at baseline and 30 days after bleaching to calculate the variations in color towards the lighter end of the scale (Delta Shade Guide Units - DSGU).

One calibrated operator measured the colour in all participants using the Vita Easyshade spectrophotomer (Easyshade, Vident, Brea, CA, USA) before and 30 days after the bleaching therapy. The L\*, a\* and b\* parameters were recorded. L\* represents the value from 0 (black) to 100 (white) and a\* and b\* represent the shade, where a\* is the measurement along the red-green axis and b\* is the measurement along the yellow-blue axis. Color change was calculated between the two assessment periods (DE) using the formula: DE = \[(DL\*)2 + (Da\*)2 + (Db\*)2\]1/2.

The patients recorded their perception of TS during the first and second bleaching sessions using the visual analogue scale VAS. This scale employs a 10-cm horizontal line with words ''no pain'' at one end and ''worst pain'' at the opposite end. Participants recorded whether they experienced TS during the treatment up to 1 h after the bleaching, from 1 h to 24 h and from 24 h to 48 h after bleaching. In the 30-day recall, patients were also asked if they experienced pain during this 30-day period. As two bleaching sessions were performed, the VAS score obtained in both bleaching sessions was considered for statistical purposes. These values were computed for the maxillary arch.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bleaching 7 days interval

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 7 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Group Type ACTIVE_COMPARATOR

In-office Dental Bleaching Conventional

Intervention Type PROCEDURE

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 7 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Bleaching 2 days interval

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 2 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Group Type EXPERIMENTAL

In-office Dental Bleaching Alternative

Intervention Type PROCEDURE

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 2 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

In-office Dental Bleaching Conventional

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 7 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Intervention Type PROCEDURE

In-office Dental Bleaching Alternative

Participants will undergo 2 sessions of in-office dental bleaching, using a 35% Hydrogen Peroxide bleaching gel, with 2 days of interval between sessions. Bleaching gel will be used in 3 15-minutes applications as indicated by the manufacturer. A 2% Potassium Nitrate and Sodium Fluoride desensitizing gel will be applied 15 minutes before the dental bleaching procedure, in both sessions.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

The selected volunteers should:

* Present Good general state of health
* Be at least 18 years of age
* Have an acceptable oral hygiene
* Present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
* Have anterior teeth with any kind of restoration.
* Be No smoker
* Have the upper right canine with color 2M2 or darker

Exclusion Criteria

The selected volunteers should not:

* Have medical history of diseases that can affect the results of the study
* Have made use of cigarettes in the last 30 days
* Have some important pathology in the oral cavity
* Be pregnant
* Be breastfeeding
* Have moderate advanced periodontal disease;
* Have consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
* Have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product
* Present gingival recession
* Present exacerbated hypersensitivity history

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes