NCT06165458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 2, 2023

Last Update Submit

December 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Color

    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

    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.

Study Arms (4)

HP6V

EXPERIMENTAL

6% hydrogen peroxide gel + violet LED

Other: 6% hydrogen peroxide gel + violet LED

HP6B

EXPERIMENTAL

6% hydrogen peroxide gel + blue LED

Other: 6% hydrogen peroxide gel + blue LED

HP35V

EXPERIMENTAL

35% hydrogen peroxide gel + violet LED

Other: 35% hydrogen peroxide gel + violet LED

HP35B

EXPERIMENTAL

35% hydrogen peroxide gel + blue LED

Other: 35% hydrogen peroxide gel + blue LED

Interventions

Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by violet LED

HP6V

Tooth whitening with 6% hydrogen peroxide gel (Lase Peroxide Lite, DMC, São Carlos, Brazil) activated by blue LED

HP6B

Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by violet LED

HP35V

Tooth whitening with 35% hydrogen peroxide gel (Lase Peroxide Sensy, DMC, São Carlos, Brazil) activated by blue LED

HP35B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pará

Belém, Pará, 66075-110, Brazil

Location

Related Publications (1)

  • Oliveira MGVV, Dutra DJB, Costa JLSG, Besegato JF, Barros APO, Oliveira RR, Araujo PV, Alvim HH. Clinical comparison of whitening efficacy and tooth sensitivity of different concentrations of hydrogen peroxide photoactivated with violet or blue LEDs. Lasers Med Sci. 2024 Jul 26;39(1):195. doi: 10.1007/s10103-024-04144-6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 11, 2023

Study Start

January 12, 2021

Primary Completion

November 3, 2021

Study Completion

February 15, 2022

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations