The Effectiveness of At-home , In-office and Combined Dental Bleaching System ：A Randomized Controlled Clinical Trial

NCT05021965 | Completed DMC

• 1 other identifier: 20210715
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system.

Conditions

Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• Change in tooth colour

  Colour parameters (CIE L\*, a\*, b\*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0). The color alteration after each session will be given by the differences between the values obtained at the sessions and the baseline (∆E).

  six weeks

Secondary Outcomes (1)

• Tooth sensitivity evaluation

  two weeks

Study Arms (4)

group 1: have two weeks of at-home tooth bleaching

EXPERIMENTAL

Participants will receive two weeks of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) for the maxillary anterior teeth.

Procedure: different combined of tooth bleaching procedure

group 2 : have two sessions of in-office tooth bleaching

EXPERIMENTAL

Participants will receive two sessions（with a 1- week interval ） of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth.

Procedure: different combined of tooth bleaching procedure

group 3 : one week of at-home and then have one session of in-office tooth bleaching

EXPERIMENTAL

Participants will receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) and then receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth.

Procedure: different combined of tooth bleaching procedure

group 4 : one week of in-office and then have one session of at-home tooth bleaching

EXPERIMENTAL

Participants will receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) and a week later receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%)for the maxillary anterior teeth.

Procedure: different combined of tooth bleaching procedure

Interventions

different combined of tooth bleaching procedure PROCEDURE

The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.

group 1: have two weeks of at-home tooth bleaching; group 2 : have two sessions of in-office tooth bleaching; group 3 : one week of at-home and then have one session of in-office tooth bleaching; group 4 : one week of in-office and then have one session of at-home tooth bleaching

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa # ckingen, Germany) ordered by brightness

You may not qualify if:

• patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant or lactating women , people with known allergy to the product ingredients, smokers, and alcohol abusers, had severe internal tooth discoloration (e.g. tetracycline stains), had bruxism or any other pathology that could cause TS (such as gingival recession or dentin exposure).

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

Study Officials

• Hao Yu, PhD

  Fujian Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice dean of school and hospital of stomatology

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: July 15, 2021
• Primary Completion: January 5, 2022
• Study Completion: March 14, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)