- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07818031
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching: A Randomized Clinical Trial (BECTS)
September 8, 2026 updated by: Esraa Eid Qurany, Minia University
Bleaching Efficacy, Color Durability, and Tooth Sensitivity After In-Office Bleaching With Peroxide Versus Non-Peroxide Systems: A Randomized Clinical Trial
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems.
The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment.
Participants will receive one of the two bleaching treatments and will be followed for six months to assess the clinical outcomes and compare the performance of both systems.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This randomized controlled clinical trial is designed to compare the clinical performance of peroxide-based and non-peroxide in-office tooth bleaching systems.
Eligible participants will be randomly allocated into two treatment groups.
Tooth color will be assessed using standardized clinical evaluation methods before treatment, immediately after bleaching, and during follow-up visits.
The study will also evaluate color stability and tooth sensitivity over a six-month follow-up period.
The findings are expected to provide evidence regarding the effectiveness and safety of both bleaching systems and to support evidence-based clinical decision-making in esthetic dentistry.
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Esraa Eid, MSc
- Phone Number: +20 1019243773
- Email: esraa.korny@nub.edu.eg
Study Locations
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt
- Recruiting
- Minia University Hospital
-
Contact:
- Esraa Eid, MSc
- Phone Number: +20 1019243773
- Email: esraa.korny@nub.edu
-
-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18-45 years.
- Good general health.
- Presence of all maxillary anterior teeth free from restorations, caries, or structural defects.
- Baseline tooth shade suitable for bleaching assessment.
- Good oral hygiene and periodontal health.
- Willingness to comply with the study protocol and attend all follow-up visits.
- Signed informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- History of tooth hypersensitivity.
- Active caries or defective restorations in the anterior teeth.
- Intrinsic tooth discoloration (e.g., fluorosis, tetracycline staining).
- Ongoing orthodontic treatment.
- Smoking.
- Use of tooth-whitening products within the previous 6 months.
- Allergy to any component of the bleaching materials.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peroxide-based in office bleaching
Participants will receive a peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.
|
Participants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
|
|
Experimental: Non-peroxide-based in office bleaching
Participants will receive a non-peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.
|
Participants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleaching efficacy measured by Whiteness Index for Dentistry (WID)
Time Frame: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
Bleaching efficacy will be assessed using the Whiteness Index for Dentistry (WID) obtained by spectrophotometric measurements of the anterior teeth.
|
Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
|
Color durability measured by CIEDE2000 color difference (ΔE00)
Time Frame: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
Color durability will be evaluated using spectrophotometric color measurements and expressed as CIEDE2000 color difference (ΔE00).
|
Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
|
|
Tooth sensitivity assessed using the Visual Analog Scale (VAS)
Time Frame: Daily during the 14-day treatment period
|
ooth sensitivity will be evaluated using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain
|
Daily during the 14-day treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
August 15, 2026
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
March 15, 2027
Study Registration Dates
First Submitted
September 8, 2026
First Submitted That Met QC Criteria
September 8, 2026
First Posted (Actual)
September 14, 2026
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-1301-2026
- 1301/2026 (Other Identifier: Research Ethics Committee, Faculty of Dentistry, Minia University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
individual participant data will not be shared because there is no plan for public data sharing beyond the analyses and results reported in the study.
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.