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Enrolling by Invitation

NCT Number: NCT07493941

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

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.

Enrolling by Invitation

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Key information

Conditions

Bleaching; Satisfactory Bleaching Efficacy Bleaching Sensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation

Other

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

35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation

Other

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.

35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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