In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.: Effectiveness, Security and Impact on Quality of Life Related to Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of color change
研究概览
简要总结
To evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.
详细描述
The aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. It will be a randomized, parallel and single blind. Participants are divided into three groups (n = 30) according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 = Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth will be evaluated in seven different times, using the color scale Vita Master Classic 3D and spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. The impact of bleaching quality of life will be assessed using the Brazilian version of the oral impact on daily performance (OIDP). The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tooth color ranging from A3 or darker, teeth with no stains and restorations without whitening experience
排除标准
- •participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.
研究组 & 干预措施
Group 1 - HP 6%
Group 1: Experimental: Office; hydrogen peroxide 6%,
干预措施: hydrogen peroxide 6% (Drug)
Group 2 - HP 15%
Group 2: Experimental: Office; hydrogen peroxide 15%,
干预措施: hydrogen peroxide 15% (Drug)
Group 3 - CP 10%
Group 3: Control: Homemade; Carbamide Peroxide 10%,
干预措施: Carbamide Peroxide 10% (Drug)
结局指标
主要结局
Evaluation of color change
时间窗: T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months ;T6:After 12 months
Visual evaluation using color scale Vita Classical 3D Master (Vita Zahnfabrik, Germany); (B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4) Quantitative evaluation using a spectrophotometer Easy Shade Advance ® (Wilcos Brazil). System CIE L \* a \* b \* - L represents the value (lightness or darkness), the value of a \* is a measure red (positive a \*) or green (negative a \*); the value of b \* is a yellow extent (b \* positive) or blue (b \* negative) and the color difference between the color coordinate is calculated as ΔE \* = \[(ΔL \*) 2 + (Δa \*) 2 + (Δb \*) 2\] 1/2.
次要结局
- Tooth sensitivity assessment(T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;)
- Impact assessment on quality of life(T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;)
- Evaluation of gingival irritation(T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;)
研究者
Cláudia Silami de Magalhães
Associate Professor IV, Department of Restorative Dentistry at the Federal University of Minas Gerais
Federal University of Minas Gerais