SEALANT-DK: Longevity and Efficacy of 6 Resin Sealants Used for Sealing Permanent Teeth in Children and Adolescents
试验速览
- 阶段
- 不适用
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Efficacy of 6 resin fissure sealants assessed by defined radiological scoring system
研究概览
简要总结
Background: Occlusal caries is the main reason for restorative therapy in the young permanent dentition, but restorations have limited survival time and may also weaken the tooth. An intact fissure sealing is an effective preventive treatment of occlusal caries lesions and may be used therapeutically to arrest the caries progression. However, the major challenge with fissure sealants is the frequent need for re-treatments, mostly due to inadequate retention.
Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used prophylactically and therapeutically in permanent molar teeth.
Study design: The study is carried out as a prospective, clinically controlled study with split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in Denmark uses 2 of the 6 sealants. The treatments are examined clinically and radiologically after 1, 2, 3, and 5 years.
详细描述
The choice of the two materials is randomized and carried out so that all materials are used equally frequent and with an even distribution between dentists and dental hygienists.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents 5-14 years of age
- •Children with 2, 4, 6 or 8 molars assessed to be in need of prophylactic or therapeutic sealing
- •The radiographic penetration of the occlusal caries lesion must be limited halfway through the dentin
排除标准
- •In case the occlusal surface is restored with communication between the restoration and the included lesion
- •Subjects with chronic diseases that could affect their caries pattern
- •Pain in teeth
结局指标
主要结局
Efficacy of 6 resin fissure sealants assessed by defined radiological scoring system
时间窗: 5 years
Radiographic scoring system: 1:Regression in depth of lesion (success), 2: Unchanged depth of lesion (success); 3: Progression in depth of lesion (failure)
Longevity of 6 resin fissure sealants assessed by defined scoring system
时间窗: 5 years
Clinical scoring system: 1: Intact sealing (success), 2: Partly loss of sealant (failure); 3: Total loss of sealant (failure)
次要结局
未报告次要终点
研究者
Azam Bakhshandeh
Associate professor
University of Copenhagen