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临床试验/CTRI/2026/03/105706
CTRI/2026/03/105706尚未招募3 期

A COMPARATIVE EVALUATION OF STAINLESS STEEL CROWNS AND COMPOSITE ONLAYS ON PERMANENT FIRST MOLARS AFTER ROOT CANAL TREATMENT IN PATIENTS WITH MOLAR INCISOR HYPOMINERALIZATION: AN IN-VIVO STUDY.

Brinda BK1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月20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
30
试验地点
1

研究概览

简要总结

This in-vivo randomized controlled trial evaluates the clinical performance of stainless steel crowns and composite onlays in permanent first molars affected by molar incisor hypomineralization after root canal treatment. Thirty children aged 8–13 years will be randomly allocated into two groups (n=15 each): Group A receiving stainless steel crowns and Group B receiving composite onlays. Sample size was calculated using comparison of two proportions formula with 80% power and 95% confidence level. Outcomes including retention, marginal adaptation, aesthetics, wear resistance (Modified USPHS criteria) and gingival health (Gingival Index) will be assessed at baseline, 6 months, and 1 year and statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
8.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Children who require root canal treatment on permanent first molars with severe hypomineralisation.

排除标准

  • Children under mild stages of hypomineralisation on permanent first molars not involving the pulp.
  • Children with signs of fluorosis, tetracycline staining, amelogenesis imperfecta, and generalised enamel hypoplasia.
  • Children who are allergic to metals.

研究者

发起方
Brinda BK
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Brinda BK

Al Azhar Dental College

研究点 (1)

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