跳至主要内容
临床试验/CTRI/2025/07/090402
CTRI/2025/07/090402尚未招募4 期

Comparing and evaluating the behavioral changes and anxiety in sensory adapted dental environment (SADE) and regular dental environment (RDE) on 6-8 years aged children: a randomized control cross over study.

Ranjeet Deshmukh Dental College and research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.To evaluate and compare behavioral changes of 6-8 years aged children in sensory adapted dental environment and regular dental environment via Venham’s behavioral rating scale.

研究概览

简要总结

The purpose of the present study is to evaluate and compare behavioral and physiological effect in a sensory adapted dental environment and regular dental environment on children’s dental anxiety during restorations.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • children having Frankel behavior rating score 2,3,4 requiring two setting for restoration of teeth with ICDSA score 3,4 and 5.

排除标准

  • Children with severe caries that may involve the pulp and Children with hearing loss, vision loss and olfactory disorders.

结局指标

主要结局

1.To evaluate and compare behavioral changes of 6-8 years aged children in sensory adapted dental environment and regular dental environment via Venham’s behavioral rating scale.

时间窗: 3 weeks

2.To evaluate and compare anxiety of 6-8 years aged children in sensory adapted dental environment and regular dental environment via Venham’s clinical anxiety scale.

时间窗: 3 weeks

次要结局

  • To evaluate the acceptance of Sensory adapted dental environment in children aged 6-8 years.(After the 2nd treatment visit)

研究者

发起方
Ranjeet Deshmukh Dental College and research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Neha Tapdiya

Ranjeet Deshmukh Dental college and research centre

研究点 (1)

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