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临床试验/CTRI/2025/09/095244
CTRI/2025/09/095244尚未招募不适用

Comparative Evaluation of Clinical Performance of Universal versus Conventional Composite Resin Restoration in Primary Molars-A Split mouth Randomized Controlled Trial

Dr Koya Naga Venkata Siva Kumari1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年10月6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
43
试验地点
1
主要终点
Clinical Performance of Restorative Material using USPHS criteria.

研究概览

简要总结

A-split Mouth design to evaluate the clinical performance of Universal Composite and Conventional Composite resin Restoration in occlusal carious primary molars among 4-9 yr old children. Children coming to out patient block in Department of Pedodontics and Preventive Dentistry will be recruited and screened. Based on inclusion and exclusion criteria ,4-9 years old children (n=43), with occlusal caries in primary molars. Written informed consent will be obtained from parents. using computer generated sequence random allocation of teeth will be done and divided into 2 groups .Group-1 Omnichroma n=(43) and Grop-2 Tetric-N-Ceram  n =(43). Caries excavation will be done using  high speed airotor handpiece and BR-45 round bur. Isolation will be done using cotton rolls and high volume suction device .Acid Etching for 15 seconds will be carried out with 37 % phosphoric acid  then rinsed with water for a minute and dried. Application of bonding agent will be done and light cured for 20 seconds. The cavity will be restored with composite material and light cured for 20 seconds. Post operative occlusal evaluation will be done using articulating paper. Fine adjustments will be made if required using finishing bur. Clinical performance of restoration will be evaluated at 6 and 12 months using modified USPHS criteria and scored as alpha, bravo ,Charlie for the following parameters  which include Color stability, Marginal adaptation ,Secondary caries ,Post operative sensitivity ,Retention, Anatomical form.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

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.Primary molars with occlusal caries in 4-9 years old children.
  • 2.Co-operative children.
  • 3.Children who are willing to be a part of the study.

排除标准

  • 1.Medically compromised patient.
  • 2.Teeth with development defects.
  • 3.Teeth that are unrestorable.
  • 4.Teeth with signs and symptoms of pain or swelling.

结局指标

主要结局

Clinical Performance of Restorative Material using USPHS criteria.

时间窗: 6 and 12 months

次要结局

未报告次要终点

研究者

发起方
Dr Koya Naga Venkata Siva Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Koya Naga Venkata Siva Kumari

Vishnu Dental College

研究点 (1)

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