Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching: a Randomized, Placebo-controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- dental color assessment
研究概览
简要总结
This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on pain sensitivity control and color change after home tooth whitening. It also evaluated the influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of patient satisfaction after bleaching treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals aged 18 to 29 years of both sexes with chroma greater than A2 in the upper incisors and canines, in the Vita Classical color scale;
- •absence of active caries lesions
- •patients who had never undergone bleaching therapy;
- •good oral hygiene and no hypersensitivity to tactile and evaporative stimuli through the Visual Analog Pain Scale;
排除标准
- •patients undergoing fixed orthodontic treatment;
- •patients with darkened non-vital teeth and/or with extensive restorations in molars;
- •presence of cracks or fractures;
- •patients allergic to the product, with the presence of gastroesophageal disorders and with dentinal exposure in anterior and/or posterior teeth.
研究组 & 干预措施
Group G1
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel
干预措施: Carbamide Peroxide (PC) 22%) + placebo gel (Other)
Group G2
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel
干预措施: Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5% (Other)
结局指标
主要结局
dental color assessment
时间窗: 21 days and 1 month after the bleaching treatment
Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L\*a\*b\* system.
dentin sensitivity
时间窗: 21 days after the start of the whitening treatment
evaluation of dentinal sensitivity during treatment through a daily questionnaire, using a visual analogue scale with values from 0 to 10, with higher values indicating a worse level of pain.
次要结局
未报告次要终点
研究者
Cecy Martins Silva
clinical professor
Universidade Federal do Para