Clinical effectiveness of two different pit and fissure sealants
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical effectiveness of Clinpro and e pit and fissure sealant using Modified Simonsen criteria at 6 month and 12 month follow up
研究概览
简要总结
To evaluate the clinical performance of two different pit and fissure sealants (Clinpro and e-pit and fissure sealant) in terms of retention and caries prevention using Modified Simonsen’s criteria. This study would be single-blinded,split mouth randomized clinical trial with 2 groups reported according to the CONSORT (Consolidated Standards of Reporting Trials) statement. Modified Randomization in Split Mouth trial will be performed in terms of the allocation of each quadrant to one of the sealing materials. The study population includes children in the age group of 6-10 years having first permanent molars with deep pits and fissures. The participant will be blinded during the study by masking the name of the sealant (Identified as A or B which the researcher only would be aware of) and the mode of delivery would be similar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •A healthy child with no significant medical history.
- •Child aged 6-10 years with fully erupted permanent molars.
- •Two permanent molars in 2 different quadrants of the mouth that are either clinically sound or have incipient enamel caries (ICDAS codes 0, 1 and 2).
- •Exhibiting minimal or no disruptive behavior (positive or positive on the Frankel behavior rating scale) Children whose parents or caregivers gave consent.
排除标准
- •Permanent molars that had dental caries (ICDAS codes 3, 4, 5 and 6).
- •Previously placed sealants or restorations on molar teeth Uncooperative children (negative or definitely negative on the Frankel behavior rating scale).
结局指标
主要结局
Clinical effectiveness of Clinpro and e pit and fissure sealant using Modified Simonsen criteria at 6 month and 12 month follow up
时间窗: 6 months and 1 year
次要结局
未报告次要终点
研究者
Sona Rose Jaison
CHRISTIAN DENTAL COLLEGE