Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Color Change (ΔE)
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Teeth with caries, cracks, hypersensitivity, restorations, veneers, or crowns in the anterior region
- •Pregnant or lactating women
- •Smoking or use of tobacco products
研究组 & 干预措施
Laser-Activated In-Office Bleaching
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a dental laser system.
干预措施: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation (Other)
Chemically Activated In-Office Bleaching (Control)
Participants receive in-office bleaching using 35% hydrogen peroxide without any external activation.
干预措施: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only (Other)
Light-Activated In-Office Bleaching
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a visible light source
干预措施: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation (Other)
结局指标
主要结局
Color Change (ΔE)
时间窗: 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.
次要结局
- 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)
研究者
Mohammed Abd El Ghany Mohammed
Principal Investigator
Tanta University