Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
研究概览
简要总结
Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth
排除标准
- •Patients with special needs;
- •Patients using orthodontic appliances;
- •systemic diseases;
- •Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
- •teeth with spontaneous painful symptomatology.
结局指标
主要结局
PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
时间窗: Every 6 months up to 24 months
Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as: * Present progression: Change in radiolucidity area of the Lesion * Absent progression: No change in the area of radiolucidity of the lesion.
次要结局
- Number of surfaces with NEW CARIES LESIONS(Up to 24 months)
- COST-EFFICACY of each protocol(up to 24 months)
- Children self-reported discomfort(baseline (Immediately after procedure))
研究者
Tamara Kerber Tedesco
PhD, Senior Lecturer
Universidade Ibirapuera