Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Tooth Shade evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Inclusion criteria: Females and males (least 18 years old), good oral and general health, no periodontal disease, no caries, and teeth colored A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany).
Eligibility Criteria
- Ages
- 21 Years to 28 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
- •Tooth fracture.
Arms & Interventions
HP18
Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite
Intervention: Bleaching treatment (Other)
HP25
Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite
Intervention: Bleaching treatment (Other)
HP40
Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite
Intervention: Bleaching treatment (Other)
Outcomes
Primary Outcomes
Tooth Shade evaluation
Time Frame: 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 Outcomes
- Tooth sensitivity evaluation(baseline, immediately after the first bleaching session, two hours later, and 7 days later.)
Investigators
Hanife ALTINIŞIK
Associate Professor
Gazi University