跳至主要内容
临床试验/CTRI/2025/07/091578
CTRI/2025/07/091578招募中不适用

TO ANALYZE THE IMPACT OF A SENSORY ADAPTED DENTAL ENVIRONMENT ON ANXIETY LEVEL OF PEDIATRIC PATIENTS

Rehan Modi1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
56
试验地点
1
主要终点
Reducing the anxiety of pediatric patients under going dental procedure

研究概览

简要总结

This study will be performed in patients visiting Department of Pediatric and Preventive Dentistry, NPDCH, Visnagar.

44 children will be included in the study according to selection criteria.

Ethical clearance for carrying out the study will be obtained prior from the Institutional Ethics Committee (IEC) before starting the study. Study will be carried out only after written informed consent from each patient and parents.

Each participant will be randomized to a sequence of two dental sitting on a 1 week recall schedule, one with a regular dental environment (RDE) and one with SADE.

After selecting the patient, Intraoral Radiograph will be taken and then evaluate it with inclusion criteria.

Caries will be removed using high speed airoter and burs.

Cavity preparation will be done and restoration of prepared cavity will be done with Glass Ionomer Cement.

Biomedical feedbacks such as Systolic, Diastolic blood pressure and Pulse rate will be monitored at baseline of treatment, interval of 5 min of treatment and at the end of the treatment in both the groups.

Subjective assessment of Dental anxiety will be performed by WBFPRS (Wong-Baker Faces Pain Rating Scale)

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 5 and 9 years Patients with class 1 caries bilaterally present Patient who exhibit uncooperative behaviour.

排除标准

  • Children with special health care conditions Patient with unrestorable tooth indicated for extraction Patient with grossly decayed tooth structure.

结局指标

主要结局

Reducing the anxiety of pediatric patients under going dental procedure

时间窗: 2 months

次要结局

未报告次要终点

研究者

发起方
Rehan Modi
申办方类型
Other [By Own]
责任方
Principal Investigator
主要研究者

Rehan Ahmed Modi

Narsinhbhai Patel Dental College and Hospital

研究点 (1)

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