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临床试验/CTRI/2025/08/093216
CTRI/2025/08/093216尚未招募4 期

Clinical evaluation of Titanium Nitride coated preformed crowns versus Stainless steel crowns in primary teeth: A split mouth, Randomized controlled trial

Shreya Bhat1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月1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
Primary outcome to be measured is Wear on opposing tooth of primary molars

研究概览

简要总结

The aim of this study is to evaluate the wear on the opposing tooth and gingival health of primary molars restored with Titanium nitride coated preformed crowns The study follows a split mouth design wherein one side of the mouth will receive a titanium nitride coated preformed crown and the contralateral tooth will receive a stainless-steel crown Primary outcome to be measured is Wear on opposing tooth of primary molars with titanium nitride coated preformed crown and stainless-steel crown using Smith and Knight wear index 1984 Secondary outcome to be measured is gingival health of primary molars with titanium coated preformed crowns and stainless-steel crown using Gingival index given by Loe and Silness 1963 Patients will be required to report for follow ups at 6th month and 12th month

研究设计

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

入排标准

年龄范围
4.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Patients 4 to 7 years of age Patients with Frankl behavior rating 3 and 4 Primary molar in functional occlusion with opposing tooth Primary molar with carious lesion involving two or more surfaces • Primary molars with at least two third root remaining • Primary molars treated with pulpectomy and pulpotomy.

排除标准

  • Patients with Frankl behavior rating 1 and 2 Primary molars not in functional occlusion with opposing tooth Primary molars with complete loss of crown structure Primary molars with less than two third root remaining Primary molars with mobility Patients with nickel allergy.

结局指标

主要结局

Primary outcome to be measured is Wear on opposing tooth of primary molars

时间窗: 6 months and 1 year

with titanium nitride coated preformed crown and stainless-steel crown using Smith and Knight wear

时间窗: 6 months and 1 year

index (1984)

时间窗: 6 months and 1 year

次要结局

  • Secondary outcome to be measured is gingival health of primary molars with titanium coated preformed(crowns and stainless-steel crown using Gingival index given by Loe and Silness (1963))

研究者

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

Shreya Bhat

Manipal college of Dental Sciences, Manipal

研究点 (1)

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