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临床试验/CTRI/2024/05/066705
CTRI/2024/05/066705已完成4 期

Comparative evaluation of effectiveness of ceramic burs, polymer burs with carbide burs for caries excavation in primary molars among children aged 4-8 years- A randomized clinical trial

Dr Aishwarya Arunkumar Patil1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Time taken for caries excavation using ceramic burs, polymer burs and carbide burs

研究概览

简要总结

The Principal Investigator will perform the procedure under Standard Operating Protocols. The procedure will be carried out in 45 min for each patient in all the three groups. Patients allocated to Group I will be treated using Ceramic Bur, Group II using Polymer Bur and Group III will be treated using Carbide Bur. The selected child will be made to sit comfortably on the dental chair, the procedure will be completely explained to the parent as well as the child by the Principal Investigator (PI). A case history will be recorded for the present study so as to have a systematic and methodological recording of all the observations and information. After recording the preliminary information, clinical examination will be carried out on a dental chair under standard operating protocol. The Principal Investigator (PI) will assess the time taken by the caries excavating burs for caries removal. A trained pediatric dentist will assess caries removal efficacy of the burs using caries detecting dye and caries removal scoring criteria. If caries is detected by the dye on the prepared cavity, the caries will be excavated. Additional time taken by the bur for caries excavation will be noted if caries is detected after the application of caries detecting dye. Post caries excavation cavity will be restored using Glass Ionomer restorative material.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and 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.
  • Mandibular primary molars which require class I restorations.
  • Caries involving dentin clinically and radiographically.
  • Carious tooth without any history of spontaneous pain.

排除标准

  • Presence of any clinical/radiographic sign and symptom of pulpal and soft tissue pathology.
  • Grossly decayed teeth.
  • Children with negative (-) and definitely negative (--) behavior according to Frankl’s behavior rating scale.
  • Presence of developmental defects in primary molar.
  • Children with systemic conditions or special health care needs.
  • Children and/or Parents who are unwilling to participate in the study.

结局指标

主要结局

Time taken for caries excavation using ceramic burs, polymer burs and carbide burs

时间窗: Baseline and Post caries excavation

次要结局

  • Caries removal efficacy score for caries excavation using ceramic burs, polymer burs & carbide burs(Baseline & Post caries excavation)

研究者

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

Dr Aishwarya Arunkumar Patil

KLE VK Institute of Dental Sciences

研究点 (1)

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