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

NCT07493941 | Enrolling By Invitation DMC

• 1 other identifier: Dental Bleaching
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleaching; Satisfactory; Bleaching Sensitivity; Bleaching Efficacy

Keywords

Bleaching; Color Stability; Tooth Sensitivity; Surface Roughness

Outcome Measures

Primary Outcomes (1)

• Color Change (ΔE)

  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 Outcomes (3)

• Enamel Surface Roughness (Ra, µm)

  Baseline and immediately after bleaching procedure

• Tooth Sensitivity

  Immediately after bleaching, 24 hours post-treatment, and up to 7 days post-treatment

• Patient Satisfaction

  Immediately after treatment and at 3-month follow-up

Study Arms (3)

Laser-Activated In-Office Bleaching

EXPERIMENTAL

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

Light-Activated In-Office Bleaching

EXPERIMENTAL

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

Chemically Activated In-Office Bleaching (Control)

ACTIVE COMPARATOR

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

Interventions

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.

Light-Activated In-Office Bleaching

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.

Chemically Activated In-Office Bleaching (Control)

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

Laser-Activated In-Office Bleaching

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, 31527, Egypt

Location

Related Publications (5)

• Pereira R, Silveira J, Dias S, Cardoso A, Mata A, Marques D. Bleaching efficacy and quality of life of different bleaching techniques - randomized controlled trial. Clin Oral Investig. 2022 Dec;26(12):7167-7177. doi: 10.1007/s00784-022-04678-5. Epub 2022 Aug 17.

  PMID: 35976497 RESULT

• Atay A, Canpolat D, Sismanoglu S, Usumez A. Comparative evaluation of different bleaching agents on the color stability, hardness and surface roughness of indirect esthetic restorative materials with different manufacturing methods. BMC Oral Health. 2025 Dec 4;26(1):36. doi: 10.1186/s12903-025-07355-7.

  PMID: 41340117 RESULT

• Alkhuzaie AI, Elawsya ME, Elkholany NR. Impact of Different Bleaching Methods on Surface Roughness, Microhardness, and Tooth-Restoration Interface of Ormocer- and Methacrylate-based Restorative Systems. J Clin Exp Dent. 2025 Apr 1;17(4):e422-e431. doi: 10.4317/jced.62614. eCollection 2025 Apr.

  PMID: 40375839 RESULT

• Jiang NW, Cheng YL, Huang HL, Zhong BJ, Bi W, Yu H. Correlation between patient satisfaction and color changes after tooth bleaching. J Esthet Restor Dent. 2024 Mar;36(3):437-444. doi: 10.1111/jerd.13200. Epub 2024 Feb 1.

  PMID: 38303586 RESULT

• Kurucu Karadeniz BK. Effects of different bleaching methods on the color stability, microhardness, and surface roughness of single-shade composites. BMC Oral Health. 2025 Dec 12;25(1):1895. doi: 10.1186/s12903-025-07147-z.

  PMID: 41387842 RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2026
• Primary Completion: July 2, 2026
• Study Completion: July 3, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)