SEAL-DK: Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition in Children and Adolescents. RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 521
- 主要终点
- Effectiveness of fissure sealants
研究概览
简要总结
The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment strategies: non-invasive fissure sealing and invasive restorative treatment of manifest occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the project is to promote the understanding of the possibilities of non-invasive treatment of occlusal caries lesions in the permanent dentition, and to increase the present knowledge about the optimal threshold for sealing or restoration, respectively, when treating such lesions.
The project is carried out as a randomized study of the two treatment strategies: non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is emphasized that no treatment shall be carried out, if conflicting the participating dentists' perception of clinically proper caries treatment, and that the results shall have a high reliability and consistency.
The hypothesis is that caries progression can be stopped by non-invasive fissure sealing changing the threshold and postponing the time for invasive restoration.
详细描述
Background: The first restoration is fatal for the prognosis of the tooth. Studies have shown that caries progression can be stopped with a tight sealing which may even lead to re-mineralization of lesions.
Aim: To investigate the possibility of treating manifest occlusal caries with non-invasive sealing instead of conventional resin restoration.
Study design: the study is carried out as a prospective, randomized clinical study (RCT). Primary, occlusal caries lesions in 521 patients, aged 6-17 years old were treated by non-invasive resin based sealing (n= 368) or resin based restoration (n=153). The dentists or patients were not free to choose the treatment type. Randomization between sealing and restoration (2:1) was made by computer for each practitioner at the University of Copenhagen and kept at the clinics in sealed envelopes. The treatments are examined clinically and radiographically after 1, 2, 3, 5, 7 and 10 years. The treatments are performed and controlled by 68 general practitioners from Public Dental Health Care Service in 9 Danish municipalities.
Sealing: The dentists use material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
Restoration: The dentists use preparation design and material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •each patient should have one manifest occlusal caries lesion in need of restorative treatment
- •the radiographic depth of the lesion should be limited to half through the dentin
- •written informed consent from children and parents should be obtained before treatment
排除标准
- •when the occlusal lesion had communication with an approximal caries lesion or occlusal/approximal restoration
- •the tooth was hypomineralized
- •in case of serious chronic diseases affecting the caries experience and activity
结局指标
主要结局
Effectiveness of fissure sealants
时间窗: 10 years
Radiographical scoring system: 1) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
Longevity of fissure sealants
时间窗: 10 years
Clinical scoring system: 1) Intact sealing without caries progression (success) 2: Loss of sealant with or without caries progression (failure)
次要结局
- Effectiveness of resin based restoration(10 years)
- Longevity of resin based restoration(10)
研究者
Azam Bakhshandeh
Associate professor
University of Copenhagen