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临床试验/CTRI/2024/03/064790
CTRI/2024/03/064790尚未招募4 期

Comparison of full-coronal restorations using strip crowns and CAD CAM crowns in primary maxillary incisors- A randomized clinical trial

Dr Deepthi L1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月5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
40
试验地点
1
主要终点
To evaluate and compare clinical performance of esthetic full-coronal restorations in children as follows

研究概览

简要总结

This study is a randomized clinical trial comparing full coronal restorations using strip crowns and CAD CAM crowns in primary maxillary incisors in 40 sample of children aged between 3 to 5 years with early childhood caries. Each child will be examined and those who fulfil the inclusion criteria will be selected and will be randomly distributed into 2 groups with 20 samples each.  Appropriate anaesthesia will be administered. Rubber dam isolation followed by caries removal will be done. Tooth preparation will be done accordingly and strip crowns or CAD CAM crowns will be placed. All the above samples will be assessed for color match, marginal discoloration, marginal integrity, surface texture ,post operative sensitivity, secondary caries and fracture, immediately after crown placement ,at 3 months, at 6 months and 12 months follow up.  The data will be subjected for statistical analysis.

研究设计

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

入排标准

年龄范围
3.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Healthy children of 3-5 years of age from either gender. Children with ECC.
  • Carious primary maxillary incisors with involvement of minimum two surfaces, out of which one must be palatal surface and at least 2/3rd clinical crown remains after caries removal. Children with behavior scale 3 and 4 (Wright’s modification of Frankl’s rating). Adequate root support with no mobility.

排除标准

  • Primary maxillary incisors requiring pulp therapy or already pulp treated.
  • Presence of single surface caries.
  • Children with traumatic injuries.
  • Children with special health care needs.
  • Children with parafunctional habits, e.g.: bruxism.
  • Children with developmental anomalies.

结局指标

主要结局

To evaluate and compare clinical performance of esthetic full-coronal restorations in children as follows

时间窗: crowns will be assessed at baseline, at 3 months, at 6 months and 12 months follow up

1.Primary maxillary incisors restored with strip crowns (celluloid crown form with composite resin).

时间窗: crowns will be assessed at baseline, at 3 months, at 6 months and 12 months follow up

2.Primary maxillary incisors restored with custom made CADCAM composite crowns.

时间窗: crowns will be assessed at baseline, at 3 months, at 6 months and 12 months follow up

次要结局

未报告次要终点

研究者

发起方
Dr Deepthi L
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

DR DEEPTHI L

Rajarajeswari Dental College and Hospital

研究点 (1)

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