跳至主要内容
临床试验/CTRI/2025/05/087760
CTRI/2025/05/087760招募中不适用

Evaluation of the effectiveness of using a play-based distraction in reducing the gag reflex while taking intraoral Periapical radiographs in pediatric patients

Karuna YM1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
The severity of gagging during radiographic procedures will be visually evaluated by two examiners, and scoring will be done by consensus using the gagging severity (GS) criteria [13], which rates gagging severity from 0 (no or mild gagging) to 3 (worst gagging, radiograph cannot be taken).

研究概览

简要总结

Theincreased gag reflex is frequently seen in children and presents problemsduring various dental procedures including intra-oral radiography. The gaggingsensation prevents the child from cooperating while taking radiographs,subsequently necessitating repeat radiographs and more radiation exposures. Thus,if it is possible by any means to distract a child while taking radiographs, itwill reduce the gagging reflex, thereby helping the pediatric dentist obtain anaccurate radiograph with the least faults and less radiation exposure.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
6.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • •The study will include children aged 6-13 years, whose parents agreed to give written consent, children with a minimum requirement of two intra-oral periapical radiographs either in the maxillary or mandibular molar region (both radiographic requirements in the same arch) for diagnosis or treatment planning, or as a part of the treatment, children with moderate to very severe gag reflex according to the Classification of Gagging Problem (CGP) index, and children with Frankl’s definitely positive or positive behavior ratings.

排除标准

  • •Uncooperative children, those who have special health care needs, are undertaking any kind of systemic medications during the study period, with emergency dental treatment needs, and if the patient has a minimum of two intra-oral periapical radiographic requirements, but both are not on the same arch, will be excluded.

结局指标

主要结局

The severity of gagging during radiographic procedures will be visually evaluated by two examiners, and scoring will be done by consensus using the gagging severity (GS) criteria [13], which rates gagging severity from 0 (no or mild gagging) to 3 (worst gagging, radiograph cannot be taken).

时间窗: The severity of gagging will be evaluated at base line (single point assessment)

次要结局

  • Correlation between dental anxiety & gag reflex of the child patient will also be assessed.(At baseline only (single point assessment))

研究者

发起方
Karuna YM
申办方类型
Other [Self funded]

研究点 (1)

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