Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs

December 9, 2023 updated by: Cecy Martins Silva, Universidade Federal do Para

Clinical Comparison of Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs

This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pará
      • Belém, Pará, Brazil, 66075-110
        • Federal University of Para

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • at age 18 or older, with good general and oral health;
  • possessing all six natural and healthy upper anterior teeth with a color shade of A2 or darker, determined by comparison with the Vita Classic scale;

Exclusion Criteria:

  • pregnant and breastfeeding women;
  • individuals with internal tooth discoloration (tetracycline stains, fluorosis or hypoplasias);
  • smokers, or those with veneers or restorations on the teeth in questions were excluded;
  • gingival recession;
  • dentin exposure;
  • periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP6V
6% hydrogen peroxide gel + violet LED
Other: 6% hydrogen peroxide gel + violet LED
Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by violet LED
Experimental: HP6B
6% hydrogen peroxide gel + blue LED
Other: 6% hydrogen peroxide gel + blue LED
Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by blue LED
Experimental: HP35V
35% hydrogen peroxide gel + violet LED
Other: 35% hydrogen peroxide gel + violet LED
Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by violet LED
Experimental: HP35B
35% hydrogen peroxide gel + blue LED
Other: 35% hydrogen peroxide gel + blue LED
Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by blue LED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color
Time Frame: Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching
A operator measured the color of the six upper anterior teeth using a digital spectrophotometer (VITA Easyshade V, Wilcos, Petrópolis, RJ, Brazil).
Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching
Bleaching Sensitivity
Time Frame: Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.
The degree of tooth sensitivity of patients was recorded using a visual analogue scale (VAS) from 0 to 10, where 0 represents no tooth sensitivity and 10 represents the greatest tooth sensitivity ever felt by the patient.
Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Para

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPara017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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