Caries Associated With Restorations or Sialants Cognition and Identification in Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Change from baseline in number of surfaces restored requiring new intervention
研究概览
简要总结
This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.
详细描述
The study will consist of a randomised controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the FDI criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). And the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - conservative group). Patient evaluations will be performed yearly after 12 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, clinical operators responsible for dental treatment, and the examiner who will assess the outcomes will be blind to the allocation group of the participants.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients seeking dental treatment at the School of Dentistry;
- •Age between 18 and 60 years;
- •Patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth.
排除标准
- •Patients who refuse to participate in the research;
- •Patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service;
- •Patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the Faculty of Dentistry;
- •Patients who reside in other locations and who can not return for periodic follow-up of the interventions.
结局指标
主要结局
Change from baseline in number of surfaces restored requiring new intervention
时间窗: 12 months, 24 months
The primary endpoint will be the number of surfaces restored requiring intervention, which is composed of the sum of components with different levels of severity: number of surfaces with new caries lesions, number of surfaces restored in need of repair, replacement, teeth with episodes of pain, teeth requiring endodontic treatment or extraction.
次要结局
- Cost-effectiveness measured by a scale(12 months, 24 months)
- Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14)(12 months, 24 months)
研究者
Maximiliano Sergio Cenci
PhD
Federal University of Pelotas