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临床试验/CTRI/2022/08/044891
CTRI/2022/08/044891尚未招募4 期

Comparative evaluation of retention and caries incidence of three different pit and fissure sealants using “CCC†evaluation system- A Double Blinded Randomized Controlled Clinical Trials

Dr Hariprasath Nagarajan3 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2023年2月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
246
试验地点
3
主要终点
CCC evaluation system -

研究概览

简要总结

The dental council of India National Oral Health Survey from 2002-2003 revealed the prevalence of dental caries is 49.8% with a mean decayed, missing and filled teeth (DMFT) index of 2.5 among 12 years old individuals and 3.4 among the 15 years old individuals. With this picture in mind, the public health dentist has a moral obligation to spread awareness on oral diseases and to promote oral health ultimately leading to a better quality of life. In alignment with the principle of “prevention is better than cureâ€, in depth research on pit and fissure sealants can prove to be a valuable tool in reduction of mean DMFT rate in a community. In consequence, a double blinded randomized controlled clinical trial will be done using three different pit and fissure sealant among 12 to 15 year old young adolescents in rural Tamil Nadu with the follow up of 1 year where the evaluation will be done every 3 months interval. A total of 246 participants were randomly allocated to three groups (n=82).

VOCO twinky star flow (Compomer) , Ionoseal (Flowable GIC), and Ultraseal XT hydro (Hydrophilic sealant) are the three different types of sealants that will be used in the trial.. A single operator will perform the sealant application in the allocated tooth during the single visit.

The followup examination and evaluation of the pit and fissure sealant will be performed by the primary investigator who was blinded to interventional groups. At 3, 6, 9 and 12 month intervals, the sealants will be evaluated using the CCC evaluation system.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Children aged 12-15 years old who were apparently healthy without any known history of systemic illness, whose parents consented for their participation and teeth with ICDAS scoring 0,1 and 2 are the inclusion of the study.

排除标准

  • Children with suspected caries, enamel hypoplasia, or dental fluorosis and children who were uncooperative or refused dental treatment.
  • Children who developed any complications during the study period were excluded from the study.

结局指标

主要结局

CCC evaluation system -

时间窗: 3rd,6th,9th and 12th month

Discolouration, retention rate and coverage

时间窗: 3rd,6th,9th and 12th month

次要结局

  • color change in the dental sealant, coverage of the sealant and secondaries caries at 3rd, 6th, 9th and 12th month(1 year)

研究者

发起方
Dr Hariprasath Nagarajan
申办方类型
Other [self]

研究点 (3)

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