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临床试验/CTRI/2025/06/088848
CTRI/2025/06/088848尚未招募Phase 3 4

Comparative evaluation of class 1 cavity preparation using magnified mouth mirror, loupes and conventional mouth mirror: A Randomized Clinical Trial

Dr Shaik Sameera1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年6月24日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Caries removal without any residual caries remained with help of different interventions

研究概览

简要总结

Over the past few decades, technological advances in endodontics have been quantum leaps from direct vision to magnification. Despite the growing body of evidence suggesting that the of magnification improves visual acuity, the dentist’s posture and the quality of dental procedures. In dentistry, loupes and operating microscopes have become part of the normal equipment of many dentists. They improve near visual acuity and help to compensate for visual deficiencies. The prime treatment objective for carious teeth requiring operative intervention is complete removal of infected dentin followed by placement of a well-sealed, long-lasting restoration. Tactile and visual criteria are normally used to render a cavity caries-free, and the idea of a diagnostic aid that would differentiate infected dentin was considered desirable.  Hence the present study intends to evaluate the magnified mouth mirror, magnification loupes in removal of carious dentin in class I cavity preparation.

 Aim: This study aimed to assess the impact of magnified mouth mirror and magnification loupes on vision and quality of cavity preparation on primary molars.

Objective: To evaluate the quality of class 1 cavity preparation in children aged between 7 to 12 years using magnification loupes, magnified mouth mirror and conventional mouth mirror.

The randomized clinical trial was carried out in the Department of Paediatric and Preventive Dentistry,

Narayana Dental College and hospital, Nellore. The informed consent was obtained from the parents of the children who participated in the study.

A sample of 45 healthy children aged 7-12 years with 45 primary molar teeth showing dentinal caries requiring class I restoration will be selected and divided into three groups (15 in each group) using simple randomization. Group 1 : Caries removed using magnification loupes; Group 2: Caries removed using magnified mouth mirror; Group 3: Caries removes using conventional mouth mirror. X-ray will be taken to fulfil all inclusion criteria and to exclude caries in proximal surfaces. After caries excavation using a handpiece and hand instruments, The cavity preparation was considered as caries-free when a hard cavity floor was felt upon gentle pressure with a dental explorer that did not stick in the dentin. The dye was applied for 10 seconds and was rinsed off with sterile saline. The efficacy was graded from 0 to 5 by the co-investigator using the criteria proposed by Ericson et al. pictures of the tooth stained by residual caries will be taken using macro lens attached to android mobile phone. Finally, the data will be analyzed statistically to determine the variations between the three group.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
7.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children aged between 7-12 years of age 2.Caries involving occlusal surface of primary molars 3.Caries involving buccal and lingual surfaces of primary molars.

排除标准

  • 1.Children less than 7 years of age 2.Caries involving proximal surface of primary molars 3.Caries involving pulp 4.Children with special health care needs.

结局指标

主要结局

Caries removal without any residual caries remained with help of different interventions

时间窗: 1

次要结局

  • comparison of which intervention is better helpful in removing caries(1)

研究者

发起方
Dr Shaik Sameera
申办方类型
Other [Self sponsor]
责任方
Principal Investigator
主要研究者

Shaik Sameera

Narayana Dental College and Hospital

研究点 (1)

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