Evaluation of retention of pit and fissure sealants placed with and without Enamel Deproteinization pre-treatment among adolescents- A Split mouth Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1. RETENTION
研究概览
简要总结
TITLE- Evaluation of retention of pit and fissure sealants placed with and without Enamel Deproteinization pre-treatment among adolescents- A Split mouth Randomized Controlled Trial.
RESEARCH QUESTION Is there any difference in the six months retention rate of Resin based, light cure pit and fissure sealant when pre-treated with enamel deproteinization as compared to that when applied without any pre-treatment among adolescents aged 15-18 years?
The question is given in the PICOT format as follows:
P (POPULATION): 15-18years old adolescents.
I (INTERVENTION): Pit and fissure sealant application with enamel deproteinization
C (COMPARISON): Pit and fissure sealant application without enamel deproteinization
O (OUTCOME): Retention rate
T (TIME): Six Months
(S- STUDY DESIGN): Randomized controlled clinical trial- a split mouth technique
AIM: To compare the six months retention rate of Resin based, light cure pit and fissure sealant applied with and without Enamel Deproteinization pretreatment among 15-18 years old adolescents.
OBJECTIVES:
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To evaluate retention rate of Resin based, light cure pit and fissure sealant applied with Enamel Deproteinization pre-treatment at one week, one month, three months and six months.
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To evaluate retention rate of Resin based, light cure pit and fissure sealant applied without Enamel Deproteinization pre-treatment at one week, one month, three months and six months.
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To compare retention rate of Resin based, light cure pit and fissure sealant applied with and without Enamel Deproteinization pre-treatment at one week, one month, three months and six months.
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To compare application time of Resin based, light cure pit and fissure sealants with and without Enamel Deproteinization pre-treatment at first visit only. 5. To evaluate and compare the pain/ discomfort tolerance using a Visual Analogue Scale (VAS) during the application procedure at first visit only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient related criteria: 1) Cooperative adolescents aged from 15-18 years old.
- •Healthy adolescents with no history of previous systematic diseases that can affect their oral health.
- •Adolescents with Dean Fluorosis index of 0,1 and 2 Tooth related criteria: 1) Both mandibular second permanent molars which are fully erupted and having deep narrow central fissures and supplemental grooves.
- •Second permanent molars’ occlusal surfaces with scores of 0, 1, or 2 according to the International Caries Detection and Assessment System II (ICDAS II) 3) Teeth selected is in contact with the antagonist tooth 4) Teeth reported as sensitive to any type of stimulus were also excluded.
排除标准
- •Adolescents with known allergy to any of the resins used, 2) Adolescents having proximal caries, clinically detectable caries, developmental defects or hypoplastic teeth.
- •Any professionally applied caries preventive measures carried out in the last two years.
- •Adolescents with bruxism or malocclusion 5) Adolescents with mental and/or physical disorders 6) Adolescents with residence outside of the city of Faridabad, insufficient address for follow-up, or unwillingness to return for follow-up.
结局指标
主要结局
1. RETENTION
时间窗: 1 WEEK | 1 MONTH | 3 MONTHS | 6 MONTHS
2. SEALANT EVALUATION
时间窗: 1 WEEK | 1 MONTH | 3 MONTHS | 6 MONTHS
3. SEALANT EVALUATION TIME
时间窗: 1 WEEK | 1 MONTH | 3 MONTHS | 6 MONTHS
次要结局
- Acceptance of both the procedures by the same patient will be recorded using(VAS after sealant application)