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临床试验/CTRI/2024/10/075134
CTRI/2024/10/075134尚未招募不适用

The effect of dental loupes on caries excavation and quality of restoration during restorative procedure among 6-12 year old children - A randomized clinical trial

self1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
quality of restoration and caries excavation

研究概览

简要总结

Background: The principles of minimally invasive dentistry have gained prominence, emphasizing the importance of magnification tools such as dental loupes in enhancing treatment quality and precision. However, limited research exists on their efficacy in pediatric dentistry.

Objective: This study aims to evaluate the effects of dental loupes on caries excavation efficiency and the quality of restorations in children aged 6 to 12 years.

Methods: A randomized, split-mouth design will be employed, involving 30 children with class 1 dental caries in primary and permanent first molars. Participants will be divided into two groups: Group A will receive rotary and hand caries excavation with dental loupes, while Group B will undergo the same procedures without loupes. Caries removal will be assessed using visual-tactile criteria by Bjorndal et al., and the quality of restorations will be evaluated using modified USPHS criteria. Statistical analysis will include frequency percentages and chi-square tests to compare outcomes between the two groups.

Results: The study anticipates that the use of dental loupes will significantly improve caries removal efficiency and restoration quality compared to procedures performed without loupes.

Conclusion: This research aims to provide valuable insights into the role of dental loupes in pediatric restorative dentistry, potentially influencing clinical practices and promoting the adoption of magnification tools to enhance treatment outcomes for young patients.

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
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children of 6-12 years of age b.
  • Children with class 1 dental caries in primary and permanent 1st molar c.
  • No history of pain, swelling.

排除标准

  • Patient with no consent b.
  • Medically compromised children.

结局指标

主要结局

quality of restoration and caries excavation

时间窗: baseline, 1day, 3months

次要结局

未报告次要终点

研究者

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

MArumathi

tagore dental college and hospital

研究点 (1)

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