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临床试验/CTRI/2025/06/088724
CTRI/2025/06/088724已完成不适用

Evaluation of Childs Behavior and Anxiety level during application of Optra Dam and Rubber Dam Isolation in Children: A Randomized Control trial.

Maulana Azad Institute of Dental Sciences Self1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
1.Child’s Behaviour before application and after removal of Optra Dam and Rubber Dam isolation at First visit.

研究概览

简要总结

The Rubber Dam system not only offers isolation but also has several additional advantages, such as protection from aspiration, provision of good access/visibility, protection of the soft tissue, and minimization of aerosol-related cross-infections. It can also alleviate the fear of intrusion, as while the rubber dam is in place, child patients perceive that the treatment is taking place outside of their mouth. However, the application of this system is difficult in younger children and may induce anxiety. Nonetheless, Optra Dam is the latest addition to the rubber dam family. It is even more flexible and enables the operator to position it easily and appropriately into the oral cavity of the patient. This may reduce the anxiety associated with the placement of Optra Dam. Hence, this study is planned to evaluate the benefits of New Isolation system in younger children.

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
3.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children of age 3 to 5 years Children with First dental visit.
  • Children with Frankl III and IV rating Children with at least two teeth with Class I caries in primary dentition.
  • Apparently healthy children without any systemic disease.

排除标准

  • Children with Frankl I and II rating Children having dentoalveolar abscess or dental trauma.

结局指标

主要结局

1.Child’s Behaviour before application and after removal of Optra Dam and Rubber Dam isolation at First visit.

时间窗: At Baseline , and at 1 week

2.Child’s Behaviour before application and after removal of Optra Dam and Rubber Dam isolation at 1 week interval.

时间窗: At Baseline , and at 1 week

3.Child’s Anxiety level before application and after removal of Optra Dam and Rubber Dam isolation at First visit.

时间窗: At Baseline , and at 1 week

4.Child’s Anxiety level before application and after removal of Optra Dam and Rubber Dam isolation at 1 week interval

时间窗: At Baseline , and at 1 week

次要结局

  • Maternal Anxiety level(Maternal Anxiety level)

研究者

发起方
Maulana Azad Institute of Dental Sciences Self
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Farheen Sultan

Maulana Azad Institute of Dental Sciences

研究点 (1)

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