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NCT Number: NCT07597044

Evaluation of Sensitivity and Color Change of Different Protocols of In-office Dental Bleaching

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, 40 participants with color 2M2 or darker (Using OM1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with a 40% hydrogen peroxide gel with a 1-week interval. Participants were enrolled in two groups. In one group, the bleaching product was used according to manufacturer's instructions (40-minutes application in each section). In the other group, the bleaching product was used in two 20-minutes applications in each section.The investigators recorded the TS up to 48h 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.

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This study is active but is not currently recruiting participants.

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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 71 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria. A total of 40 participants were included in this study. The participants were randomly divided in the 40-minutes or 2x20-minutes groups.

During the in-office sessions, participants had the gingival tissue isolated of the teeth using a light-cured resin dam (Opal Dam, Ultradent Products International, Salt Lake, Utah, USA). After that, the 40% hydrogen peroxide gel (Opalescence Boost, Ultradent) was applied in one 40-min application according to the manufacturer's directions in all upper and lower incisors, canines and premolars, or was applied in the same teeth, but during 2 x 20-min applications, with no interval between them. After 20 minutes, the bleaching gel was removed with water spray before the second 20 minutes application. After 7 days this procedure was repeated using the same protocols.

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 color 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 hand from 24h 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

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, alcool 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

Standard in-office tooth bleaching

Procedure

Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.

Alternative in-office tooth bleaching

Procedure

Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed with water, and another application of 20 minutes will be made.

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 with scale

    Time frame: 30 days after dental bleaching session

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

  2. Color change with spectrophotometer

    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
2025
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 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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