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

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

Study Overview

• Status: Completed
• Conditions: Tooth Bleaching
• Intervention / Treatment: Procedure: different combined of tooth bleaching procedure

Detailed Description

The participants with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 4 groups according to the different tooth bleaching protocol：at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth bleaching （Lasts 14 days and at least 8 hours every day ）with 10% Carbamide peroxide(Opalescence PF 10%) , group 2 will receive two sessions （with a 1- week interval ）of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)，group 3 will receive one week of at-home tooth bleaching （Lasts 7 days and at least 8 hours every day ）and then the eighth day receive one session of in-office tooth bleaching , group 4 receive one session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day . Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 month after the completion of bleaching (T4). CIEDE2000 colour difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350004
      • Fujian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1: have two weeks of at-home tooth bleaching; 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; The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
Experimental: group 2 : have two sessions of in-office tooth bleaching; 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; The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
Experimental: group 3 : one week of at-home and then have one session of in-office tooth bleaching; 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; The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
Experimental: group 4 : one week of in-office and then have one session of at-home tooth bleaching; 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; The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth sensitivity evaluation	Using the visual analogue scale (VAS) record the Tooth sensitivity (TS) throughout the entire treatment	two weeks

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Hao Yu, PhD, Fujian Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20210715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No