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临床试验/CTRI/2026/03/106814
CTRI/2026/03/106814尚未招募Phase 3 4

Comparative Evaluation of Anxiety, Comfort and Time taken during Paediatric Dental Impression Techniques : Digital Scanning vs Conventional Method - A Crossover Randomised Controlled Trial.

Dr Charulekha Y1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月30日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The anxiety levels will be monitored with a pulse oximeter.

研究概览

简要总结

This study is a Randomised Controlled Trial conducted for 30 participants in a single institution. In the first appointment Group A – 15 children will undergo digital impressions using an intraoral scanner, while Group B – 15 children will undergo conventional impressions with alginate material. In the second appointment crossover is performed and the sequence is reversed.

To ensure consistency and eliminate operator bias, all procedures will be performed by the same clinician.

Patient comfort, and gag reflex will be recorded immediately after the procedure using a Visual Analog Scale (VAS) and closed question respectively. The anxiety levels will be monitored with a pulse oximeter. The total time taken for each impression is measured in seconds using a stopwatch.

All impressions and subsequent measurements will be performed by the principal investigator, while an independent reviewer will observe the procedures to ensure adherence to the study protocol and to validate the accuracy of the data collection. The data collected will be subjected to statistical analysis using appropriate tests.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Cooperative children in the 6–10 years age group.
  • Children not in treatment with fixed orthodontic appliance.
  • Parent/guardian consent obtained.

排除标准

  • Children with systemic illness Patients with syndromes or systemic diseases History of allergy to impression materials Extremely uncooperative patients.

结局指标

主要结局

The anxiety levels will be monitored with a pulse oximeter.

时间窗: Outcome will be assessed at baseline.

次要结局

  • Patient comfort & gag reflex will be recorded immediately after the procedure using a Visual Analog Scale (VAS) & closed question respectively. The total time taken for each impression is measured in seconds using a stopwatch.(Outcome will be assessed at the baseline)

研究者

发起方
Dr Charulekha Y
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

CHARULEKHA Y

Adhiparasakthi Dental College and Hopital

研究点 (1)

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