Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction

March 19, 2026 updated by: Mohammed Abd El Ghany Mohammed, Tanta University
The purpose of this study was to conduct a randomized double-blind clinical trial to examine the efficacy of an in-office bleaching regimen with varied activation modes on color stability, surface roughness, tooth sensitivity, and patient satisfaction.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Tooth discoloration is a common esthetic concern that can negatively impact patients' self-confidence and quality of life. Contemporary restorative dentistry increasingly emphasizes minimally invasive approaches, with vital tooth bleaching emerging as a widely accepted, conservative treatment for managing extrinsic and intrinsic discoloration. The effectiveness of bleaching procedures primarily depends on the oxidative degradation of chromogenic compounds within dental hard tissues, leading to improved tooth color.

In-office bleaching techniques often incorporate various activation modes intended to enhance the efficacy of bleaching agents, accelerate treatment time, and improve clinical outcomes. These activation methods may include light-emitting diode (LED) systems, laser activation, or purely chemical activation without external energy sources. Despite their widespread use, the actual benefit of these activation modalities remains controversial, with conflicting evidence regarding their influence on bleaching effectiveness and associated adverse effects.

Study Type

Interventional

Enrollment (Estimated)

45

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 Locations

  • Egypt
    • Tanta
      • Tanta, Tanta, Egypt, 31527
        • Restorative Department, Faculty of Dentistry, Tanta University

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 20-35 years
  • Individuals seeking esthetic improvement through tooth bleaching
  • Good general and oral health, with no active periodontal disease
  • Normal vital teeth (confirmed by clinical examination)

Exclusion Criteria:

  • Teeth with caries, cracks, hypersensitivity, restorations, veneers, or crowns in the anterior region
  • Pregnant or lactating women
  • Smoking or use of tobacco products

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser-Activated In-Office Bleaching
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a dental laser system.
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation
Application of a 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) to the labial tooth surfaces, followed by activation using a dental laser according to the manufacturer's recommended parameters. The bleaching procedure is performed in a single clinical session under standardized conditions
Experimental: Light-Activated In-Office Bleaching
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a visible light source
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation
Application of a 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) followed by activation using a dental light-curing unit or LED-based bleaching system, according to manufacturer instructions.
Active Comparator: Chemically Activated In-Office Bleaching (Control)
Participants receive in-office bleaching using 35% hydrogen peroxide without any external activation.
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only
Application of 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) without the use of external energy sources, allowing the material to act chemically according to manufacturer instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color Change (ΔE)
Time Frame: Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment
Assessment of tooth color change using a digital spectrophotometer (VITA Easyshade® V, Vita Zahnfabrik, Germany). Color measurements will be recorded in the CIE L*a*b* color space, and the overall color difference (ΔE) will be calculated between baseline and subsequent time points.
Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel Surface Roughness (Ra, µm)
Time Frame: Baseline and immediately after bleaching procedure
Evaluation of changes in enamel surface roughness following bleaching procedures. A profilometer used to record average surface roughness (Ra) values in micrometers (µm)
Baseline and immediately after bleaching procedure
Tooth Sensitivity
Time Frame: Immediately after bleaching, 24 hours post-treatment, and up to 7 days post-treatment
Assessment of patient-reported tooth sensitivity associated with bleaching procedures. Visual Analog Scale (VAS) ranging from 0 (no sensitivity) to 10 (maximum unbearable sensitivity)
Immediately after bleaching, 24 hours post-treatment, and up to 7 days post-treatment
Patient Satisfaction
Time Frame: Immediately after treatment and at 3-month follow-up
Evaluation of patient satisfaction regarding esthetic outcomes and overall treatment experience. Validated questionnaire using a Likert scale (e.g., 1 = very dissatisfied to 5 = very satisfied), covering aspects such as perceived color improvement, comfort, and willingness to undergo the procedure again
Immediately after treatment and at 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2026

Primary Completion (Estimated)

April 2, 2026

Study Completion (Estimated)

April 3, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dental Bleaching

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

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.

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