Skip to main content
OpenTrials
Completed

NCT Number: NCT06394557

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Fluminense - School of Dentistry

Nova Friburgo, Rio de Janeiro, 28625-650, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

In-office Dental Bleaching Conventional

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.

In-office Dental Bleaching Alternative

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.

Primary outcomes

  1. Tooth sensitivity

    Time frame: 1 hour after dental bleaching session

    Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome) and 100 means higher sensitivity (worse outcome).

  2. Tooth sensitivity

    Time frame: 24 hours after dental bleaching session

    Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome) and 100 means higher sensitivity (worse outcome).

  3. Tooth sensitivity

    Time frame: 48 hours after dental bleaching session

    Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome) and 100 means higher sensitivity (worse outcome).

Secondary outcomes

  1. Color change

    Time frame: 30 days after dental bleaching session

    Objective color evaluation comparing tooth color against a comercial color scale from A1 to D4

  2. Objective Color change

    Time frame: 30 days after dental bleaching session

    Objective color evaluation using a spectrophotometer

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
May 1, 2024
Registry last updated
May 15, 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.

Published trials that share one or more normalized conditions with this study.