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临床试验/CTRI/2024/06/068687
CTRI/2024/06/068687尚未招募4 期

Evaluation of clinical success and parental satisfaction following stainless steel versus hybrid resin polymer crowns of mandibular primary molars in 4-9 years old children: a split mouth randomized trial

Dr. Divya1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月30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
20
试验地点
1
主要终点
To compare clinical outcomes and parental satisfaction (gingival health,plaque accumulation,marginal adaptation,retention TMJ problems wear of opposing teeth,shape size colour durability and overall satisfaction)

研究概览

简要总结

Recently introduced, Hybrid resin polymer crowns are flexible, adaptable and  durable in oral cavity. They are available as preformed crowns that offer properties of both SSC and  zirconia crowns. These crowns are biocompatible, flexible and with a snug fit on the tooth. There is a  scarcity of literature available on Hybrid resin polymer crowns comparing to the crowns traditionally  available. Therefore, the aim of this study is to clinically evaluate and compare SSC crowns and Hybrid  resin polymer crowns in primary molars.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Child with bilateral carious primary molars of same type in mandibular arch (first primary molars of both side or second primary molars of both side) indicated for crown.
  • Firm tooth with adequate support.
  • Each primary molar of the pair must have an antagonist tooth.
  • Primary teeth with at least two-thirds of the root length remaining.
  • Patient with behavioral rating of definitely positive or positive according to Frankl behavior.

排除标准

  • Patient with allergy to local anaesthesia, nickel or chromium.
  • Radiographic evidence of teeth with internal resorption and inter-radicular bone loss.
  • Children with bruxism or deep bite.
  • Children with special health care needs.
  • Severely decayed primary molars making retention and the sealing of the restoration difficult.
  • Primary molars in infra occlusion.

结局指标

主要结局

To compare clinical outcomes and parental satisfaction (gingival health,plaque accumulation,marginal adaptation,retention TMJ problems wear of opposing teeth,shape size colour durability and overall satisfaction)

时间窗: Over a period of 1,3,6,9 and 12 months

次要结局

  • To compare clinical outcomes like gingival health, plaque accumulation, retention & parental satisfaction for size, shape, colour in stainless steel versus hybrid resin polymer crowns(Over a period of 1,3,6,9 & 12 months)

研究者

发起方
Dr. Divya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Divya

University College of Medical Sciences and GTB Hospital

研究点 (1)

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