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临床试验/CTRI/2024/10/074940
CTRI/2024/10/074940尚未招募3 期

Retention and caries preventive effect of glass ionomer and resin based sealants among 7-10 years old schoolchildren: An 18 month randomized controlled trial.

Anil neerukonda institue of dental sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Retention rates

研究概览

简要总结

Aim of the study is to compare the retention and caries preventive effect of conventional glass ionomer fissure sealants and resin based fissure sealants among 7-10 years age school  children in govt.schools of Bheemunipatnam mandal. A randomized controlled clinical trial using a split-mouth technique will be carried out among 7-10 yrs aged school children in governmentschools of Bheemunipatnam mandal. Prior permission will be taken from the principals of schools.Written informed consent will be sent to the parents/guardians of children who were willing to participate,  explaining the benefits and risks involved.The principal investigator will perform the clinical examination of every participant and the contralateral first permanent mandibular molar tooth will be sealed with two different types of sealants.On one side of the mouth, Glass ionomer sealant and on another side resin based sealant  will be applied according to the manufacturer’s instructions. Retention of both the conventional and resin based sealants will be evaluated and compared by the examiner at 3,6, 12 and 18 months interval.

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
7.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children parents who had given consent.
  • Children whose first permanent molars consists of deep fissures with 0 & 1 scores,according to ICDAS classification contralaterally.

排除标准

  • )Children with special needs and uncooperative children.
  • Children with developmental anomalies like enamel hypoplasia , dental fluorosis 3)Children with bruxism or para functional habits.
  • Malocclusion with spacing, rotations and crowding.
  • Children whose teeth have insufficient isolation and thus cannot be treated with the specified application technique.

结局指标

主要结局

Retention rates

时间窗: 3 months, 6 months, 18 months

次要结局

  • caries preventive effect(3 months, 6 months, 18 months)

研究者

发起方
Anil neerukonda institue of dental sciences
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

KONATHAM REENA EVANGELINE

Anil neerukonda institute of dental sciences

研究点 (1)

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