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临床试验/CTRI/2022/06/043411
CTRI/2022/06/043411已完成不适用

Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars.

SGT University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars.

研究概览

简要总结

The hall technique is minimally invasive type of caries management technique for treating occluso-proximal carious primary molars. The hall technique has biological principle as it can arrest caries and protect the tooth until it sheds. The essential layer in the biofilm responsible for caries progression (superficial plaque layer), is left and sealed along with the caries. As a response the composition of the plaque biofilm will be altered to a less cariogenic flora.  Using hall technique, the crown is cemented without local anaesthesia, caries removal or tooth preparation. As occlusal reduction is not done in standard hall technique, there will be discrepancy in the occlusion and occlusal vertical dimension. In modified hall technique the occlusion might settle faster as compared to standard halls technique due to minimal occlusal reduction done prior to the placement of Preformed Stainless Steel Crown (PMC). In intraoperative stage, patient acceptance regarding pain and anxiety can be recorded using self-reported Wong Baker Faces Pain Rating Scale. Children have to select from six faces which represent closely to how they felt at the time of assessmentand Frankl scores can also be evaluated. This study aims to assess the occlusion after placement of preformed stainless-steel crown in occluso–proximally carious primary molars by modified versus standard hall technique over period of  12months and also to assess the child’s intraoperative behaviour acceptance after placement of preformed stainless-steel crown.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

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

入选标准

  • 1.A case of Occluso-proximal dentinal caries in primary molar 2.The lesion ICDAS should not be less than 4 and more than
  • 3.Radiographic examination should not show caries involvement more than half of dentinal shadow.
  • 4.The occlusal surface should not be involved more than half of total dimension (occlusal table).

排除标准

  • 1.Sign and Symptoms of irreversible pulpitis.
  • 2.Peri apical/ inter radicular Radiographic changes due to caries.
  • 4.Pre-treated, restorative treatment done on the tooth.

结局指标

主要结局

Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars.

时间窗: Clinical evaluation immediately, at1 week,1month,2month, 3month, and 6month for all the cases.

次要结局

  • To evaluate clinical success and effectiveness on occurrence of new caries.(Clinical evaluation and patient acceptance at 6months and 12months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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