跳至主要内容
临床试验/CTRI/2024/06/069666
CTRI/2024/06/069666尚未招募2/3 期

Comparative Evaluation Of Efficacy And Pain Perception Of Children During The Removal Of Carious Dentin Using Ceramic And Tungsten Carbide Burs: A Randomized Clinical Trial

Dr P Sravya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The primary outcome of the study is to determine the pain perception of children by using ceramic bur and tungsten carbide bur during the removal of carious dentin

研究概览

简要总结

Dentin caries can be divided into two layers. The superficial or outer layer (infected dentin) is contaminated with bacteria, which dissolves the mineralized tissue of dentin and damages the collagen matrix so that remineralization becomes impossible. The pervasive conception of “Minimal Invasive Dentistry” implies that irreversibly denatured infected carious dentin should be removed selectively and preserved as much as possible potentially sound mineralizable tooth structure.

Aim: To evaluate the effectiveness of ceramic and tungsten carbide burs in removal of carious dentin and pain perception in children aged 4-8 years

Objectives:

·        To assess the effectiveness of a ceramic bur in the removal of carious dentin and pain perception in children.

·         To assess the effectiveness of a tungsten carbide bur in the removal of carious dentin and     pain perception in children.

·         To compare the effectiveness of a ceramic bur and tungsten carbide bur in the removal of carious dentin and pain perception in children

Methodology:

The present study will be a randomized clinical trial using simple randomization. A sample of 20 healthy children aged 4-8 years with 40 primary molar teeth (bilateral) showing dentinal caries requiring Class I restoration will be selected and divided into two groups (20 in each group) using simple randomization. Group1: Caries removed using Ceramic bur on low-speed handpiece, group2: Caries removed using Tungsten carbide bur on low-speed hand piece. X-ray will be taken to fulfil all inclusion criteria and to exclude caries in proximal surfaces. The caries excavation will be terminated after hard dentin is detected. In both the groups, during the procedure by FLACC scale and after completion of procedure Wong baker faces pain rating scale will be recorded. The efficacy of caries removal will be checked using an explorer after caries excavation so it should not stick to dentin, and not giving a tug-back sensation.

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
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Healthy children of age 4-8 years attending the dental hospital Children with bilateral class I carious lesions on maxillary or mandibular either 1st or 2nd primary molars.
  • Teeth should be clinically free from any pathologic conditions other than dental caries.
  • Asymptomatic carious lesions with distinct dentin involvement verified by radiograph.

排除标准

  • Teeth showing clinical or radiographic signs of irreversible pulpitis and its sequelae.
  • Teeth with pathological conditions such as dental erosions or tooth developmental disorders carious lesions extending proximally excluded by the x-ray Children with systemic disorders.

结局指标

主要结局

The primary outcome of the study is to determine the pain perception of children by using ceramic bur and tungsten carbide bur during the removal of carious dentin

时间窗: During caries excavation | After caries excavation

次要结局

  • The secondary outcome of the study is to determine the effectiveness of ceramic bur and tungsten carbide bur in removing carious dentin(After caries excavation)

研究者

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

P Sravya

Narayana Dental College and Hospital

研究点 (1)

Loading locations...

相似试验

Reducing the pain during caries removal by using... | 临床试验