Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide

Not Applicable

Completed

• Conditions: Tooth Discoloration

• Registration Number: NCT06700434
• Lead Sponsor: Gazi University

Brief Summary

Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.

Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Primary Completion: 2023-10-15
• Status Verified: 2024-03
• Study Completion: 2024-03-15
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Women and men (at least 18 years old)
• People with good oral and general health
• People without periodontal disease
• Teeth without caries
• Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)

Exclusion Criteria

• Having undergone teeth bleaching procedure in the last 2 years,
• People with tooth sensitivity,
• Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
• People with gingival recession,
• Discoloration due to parafunction, tetracycline or fluorosis,
• Smokers,
• Tooth fracture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tooth Shade evaluation	baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session	Tooth color was objectively evaluated using VitaTM Easy Shade V spectrophotometer (VITA Zanhnfabrik, BadSckingrn, Germany). The assesment was performed with daylight (10 a.m.to 2 p.m.) considering a 6 mm area situated in the middle section of the labial surface of the upper central incisors. In order to ensure consistency, alginate impressions were taken of the upper dental arches of each participant and stone molds were created. The custom trays were fabricated by using a 2mm Essix plate (Essix C; Dentsply, FL, USA) in a vacuum press machine (Ministar, Scheu, Iserlohn, Nordrhein-Westfalen Germany). 6 mm wide holes were drilled in the middle third of the buccal face of the central incisors on this trays to serve as a guide for using Easyshade V.

Secondary Outcome Measures

Name	Time	Method
Tooth sensitivity evaluation	baseline, immediately after the first bleaching session, two hours later, and 7 days later.	To measure tooth sensitivity, participants indicated their discomfort level using a Visual Analog Scale (VAS).23 This scale is represented by a horizontal line measuring 10 centimeters in length. The endpoint of the line labeled "no pain" represents the absence of discomfort, while the opposite endpoint labeled "worst pain" represents the highest level of discomfort.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey