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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Sensitivity
• Intervention / Treatment: Procedure: Standard in-office tooth bleaching; Procedure: Alternative in-office tooth bleaching

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Nova Friburgo, Rio de Janeiro, Brazil, 28625-650
      • Universidade Federal Fluminense - School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bleaching 40 minutes; 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.	Procedure: Standard in-office tooth bleaching; 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.
Experimental: Bleaching 2x20 minutes; 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 a new application of 20 minutes will be made.	Procedure: Alternative in-office tooth bleaching; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth sensitivity	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).	1 hour after dental bleaching session
Tooth sensitivity	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).	24 hours after dental bleaching session
Tooth sensitivity	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).	48 hours after dental bleaching session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color change with scale	Objective color evaluation comparing tooth color against a comercial color scale from A1 to D4	30 days after dental bleaching session
Color change with spectrophotometer	Objective color evaluation using a spectrophotometer	30 days after dental bleaching session

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: MARCOS O BARCELEIRO, PhD, Full Professor

Publications and helpful links

General Publications

• Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
• de Paula EA, Loguercio AD, Fernandes D, Kossatz S, Reis A. Perioperative use of an anti-inflammatory drug on tooth sensitivity caused by in-office bleaching: a randomized, triple-blind clinical trial. Clin Oral Investig. 2013 Dec;17(9):2091-7. doi: 10.1007/s00784-013-0918-2. Epub 2013 Jan 31.
• de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.
• da Costa Poubel LA, de Gouvea CVD, Calazans FS, Dip EC, Alves WV, Marins SS, Barcelos R, Barceleiro MO. Pre-operative use of dexamethasone does not reduce incidence or intensity of bleaching-induced tooth sensitivity. A triple-blind, parallel-design, randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):435-444. doi: 10.1007/s00784-018-2452-8. Epub 2018 Apr 25.
• de Mendonca RP, Baliza JR, Burey A, Cavalcante LM, Loguercio AD, Calazans FS, Barceleiro MO. In vitro analysis of the pH stability of dental bleaching gels during in-office procedures. J Clin Exp Dent. 2021 Jan 1;13(1):e22-e29. doi: 10.4317/jced.57367. eCollection 2021 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tooth bleaching; tooth sensitivity
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity
• Other Study ID Numbers: UFFBleachingProtocols

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No