Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Tooth Shade evaluation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 21 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
HP18
Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite
干预措施: Bleaching treatment (Other)
HP25
Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite
干预措施: Bleaching treatment (Other)
HP40
Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite
干预措施: Bleaching treatment (Other)
结局指标
主要结局
Tooth Shade evaluation
时间窗: 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.
次要结局
- Tooth sensitivity evaluation(baseline, immediately after the first bleaching session, two hours later, and 7 days later.)
研究者
Hanife ALTINIŞIK
Associate Professor
Gazi University