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临床试验/CTRI/2025/02/080519
CTRI/2025/02/080519尚未招募不适用

Comparative evaluation of Hydrophilic and Hydrophobic Dental Sealants in preventing dental caries among 6–12-year-old school children: A split mouth randomized controlled trial

Dr Bhavna Sabbarwal1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
retention of pit and fissure sealants more than 50 percent fissure coverage

研究概览

简要总结

Background: Pit and fissure caries are challenging to deal with as the area is neither self cleaning nor accessible to conventional methods of tooth cleaning. Hence we need a good preventive measure to avoid the onset of caries in first place. Pit and fissure sealants are one such option.

Rationale: Conventional pit and fissure sealants are hydrophobic and cannot be applied where there are problems of moisture control. So isolation is mandatory for them. Hence hydrophilic sealants provide a hope to overcome the limitation.

Objectives: To assess the effectiveness of hydrophilic vs hydrophobic dentals in preventing dental caries.

Methods: It will be a split mouth randomized controlled trial among 6-14 year school children. One group will receive hydrophilic sealant and the other will receive hydrophobic one. Follow up will be done at 1, 6 and 18 months. Suitable descriptive and inferential statistics will be applied.

Expected outcome: We are expecting better retention with hydrophilic sealant material compared to hydrobhobic but no difference in cariostatic effect and discoloration. So that hydrophilic material can be recommended for newly erupted teeth that were left unsealed due to problem of moisture control among children.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Completely erupted first permanent molars with deep pits and fissures which are either caries free or exhibiting incipient non cavitated enamel lesion in the pit & fissure system and without any restoration on any of the tooth surface will be included in the study.

排除标准

  • Children with hypoplastic first permanent molars or developmental anomalies will be excluded from the study.

结局指标

主要结局

retention of pit and fissure sealants more than 50 percent fissure coverage

时间窗: at 1 month and 6 months

次要结局

  • Assessment of caries risk through AAPD criteria(at 1 month and 6 months)

研究者

发起方
Dr Bhavna Sabbarwal
申办方类型
Other [Primary investigator]
责任方
Principal Investigator
主要研究者

Dr Bhavna Sabbarwal

Post graduate Institute of Dental Sciences, Pt BD Sharma University

研究点 (1)

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