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

NCT06394557 | Active Not Recruiting

• 1 other identifier: In-office bleach 48h interval
• Study Type: interventional
• Target: 47
• 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, 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.

Conditions

Tooth Sensitivity

Keywords

dental bleaching; dentine sensitivity

Outcome Measures

Primary Outcomes (3)

• Tooth sensitivity

  Visual Analogic Scale (0-100) for Tooth Sensitivity.

  1 hour after dental bleaching session

• Tooth sensitivity

  Visual Analogic Scale (0-100) for Tooth Sensitivity.

  24 hours after dental bleaching session

• Tooth sensitivity

  Visual Analogic Scale (0-100) for Tooth Sensitivity.

  48 hours after dental bleaching session

Secondary Outcomes (2)

• Subjective Color change

  30 days after dental bleaching session

• Objective Color change

  30 days after dental bleaching session

Study Arms (2)

Bleaching 7 days interval

ACTIVE COMPARATOR

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.

Procedure: In-office Dental Bleaching Conventional

Bleaching 2 days interval

EXPERIMENTAL

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.

Procedure: In-office Dental Bleaching Alternative

Interventions

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.

Bleaching 7 days interval

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.

Bleaching 2 days interval

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, 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

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

• Rezende M, Bonafe E, Vochikovski L, Farago PV, Loguercio AD, Reis A, Kossatz S. Pre- and postoperative dexamethasone does not reduce bleaching-induced tooth sensitivity: A randomized, triple-masked clinical trial. J Am Dent Assoc. 2016 Jan;147(1):41-9. doi: 10.1016/j.adaj.2015.07.003. Epub 2015 Nov 6.

  PMID: 26562735 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

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: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: August 14, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)