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

NCT07597044 | Active Not Recruiting

• 1 other identifier: UFFBleachingProtocols
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Sensitivity

Keywords

tooth bleaching; tooth sensitivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Color change with scale

  30 days after dental bleaching session

• Color change with spectrophotometer

  30 days after dental bleaching session

Study Arms (2)

Bleaching 40 minutes

ACTIVE COMPARATOR

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

Bleaching 2x20 minutes

EXPERIMENTAL

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

Interventions

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.

Bleaching 40 minutes

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.

Bleaching 2x20 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense - School of Dentistry

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

Location

Related Publications (5)

• 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.

  PMID: 24929591 BACKGROUND

• 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.

  PMID: 23371755 BACKGROUND

• 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.

  PMID: 25257824 BACKGROUND

• 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.

  PMID: 29696420 BACKGROUND

• 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.

  PMID: 33425227 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• MARCOS O BARCELEIRO, PhD

  Full Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: October 1, 2025
• Primary Completion: January 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)