Peroxide Versus Non-Peroxide In-Office Tooth Bleaching: A Randomized Clinical Trial

NCT07818031 | Recruiting

• 2 other identifiers: MU-1301-20261301/2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Discoloration; Tooth Staining

Keywords

Bleaching; Color; Sensitivity; In-Office; Peroxide; Non-Peroxide

Outcome Measures

Primary Outcomes (3)

• Bleaching efficacy measured by Whiteness Index for Dentistry (WID)

  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)

  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)

  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

Study Arms (2)

Peroxide-based in office bleaching

EXPERIMENTAL

Participants will receive a peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.

Procedure: peroxide -based in office tooth bleaching

Non-peroxide-based in office bleaching

EXPERIMENTAL

Participants will receive a non-peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions.

Procedure: non-peroxide -based in office tooth bleaching

Interventions

peroxide -based in office tooth bleaching PROCEDURE

Participants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.

Peroxide-based in office bleaching

non-peroxide -based in office tooth bleaching PROCEDURE

Participants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.

Non-peroxide-based in office bleaching

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth Discoloration; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Central Study Contacts

Esraa Eid, MSc

CONTACT

+20 1019243773; esraa.korny@nub.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of both the clinical operator and the patient is not possible because the bleaching materials will be used in the two groups differ in their clinical application. Therefore, the patients will recognize the difference between the two procedures, and the operator is also aware of the group allocation. However, the evaluators who responsible for bleaching index, color durability, tooth sensitivity assessment, as well as the statistician will be blinded to the group assignment to minimize bias and ensure objective outcome evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Department of Conservative Dentistry, Faculty of Dentistry Minia University

Model Details: Participants will be randomly assigned to one of two parallel groups. One group will receive a peroxide-based in-office tooth bleaching treatment, and the other group will receive a non-peroxide in-office tooth bleaching treatment. Clinical outcomes will be evaluated and compared over a six-month follow-up period.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)