CTRI

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CTRI Number

CTRI/2025/05/087760 [Registered on: 28/05/2025] Trial Registered Prospectively

Last Modified On:

28/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Behavioral

Study Design

Randomized, Crossover Trial

Public Title of Study

Using play to ease dental X-rays: Reducing the gag reflex in kids with a fun distraction technique.

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Karuna YM
Designation	Associate Professor
Affiliation	Manipal College of Dental Sciences, Mangalore, Karnataka
Address	Associate Professor, Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	9964116229
Fax
Email	karuna.ym@manipal.edu

Details of Contact Person
Scientific Query

Name	Inder Preet Singh
Designation	Under graduate Student
Affiliation	Manipal College of Dental Sciences, Mangalore, Karnataka
Address	Manipal College of Dental Sciences, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	9964116229
Fax
Email	inder.saini01.as@gmail.com

Details of Contact Person
Public Query

Name	Karuna YM
Designation	Associate Professor
Affiliation	Manipal College of Dental Sciences, Mangalore, Karnataka
Address	Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	9964116229
Fax
Email	karuna.ym@manipal.edu

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Karuna YM
Address	Department of Pediatric and Preventive Dentistry, MCODS,Light House Hill Road, Mangalore, Karnataka, India 575001
Type of Sponsor	Other [Self funded]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Karuna YM	Manipal College of Dental Sciences, Mangalore	Room No.5, Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore Dakshina Kannada KARNATAKA	9964116229 karuna.ym@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K029\|\|Dental caries, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Control group	The digital intra-oral periapical radiographs will be taken by an experienced pediatric dentist using photo-stimulable phosphor (PSP) plates of size #2, depending upon the patient’s arch size, and the bisecting angle technique. The PAP plates will be exposed using an intraoral X-ray unit at 70 kvp, 8 mA, and an exposure time of 0.16 s. Radiation protection will be ensured by using protective lead aprons for the patient and the operator. For both control and play-based distraction groups, the procedures will be described to the patients, and they will be instructed to breathe deeply once and swallow before opening their mouths for film placement. The patients will be asked to perform deep breathing through the nose while taking the radiograph.
Intervention	The play-based distraction group (using acrylic thumb light)	The digital intra-oral periapical radiographs will be taken by an experienced pediatric dentist using photo-stimulable phosphor (PSP) plates of size #2, depending upon the patient’s arch size, and the bisecting angle technique. The PAP plates will be exposed using an intraoral X-ray unit at 70 kvp, 8 mA, and an exposure time of 0.16 s. Radiation protection will be ensured by using protective lead aprons for the patient and the operator. For both control and play-based distraction groups, the procedures will be described to the patients, and they will be instructed to breathe deeply once and swallow before opening their mouths for film placement. The patients will be asked to perform deep breathing through the nose while taking the radiograph. For the play-based distraction group, in addition to these basic instructions, the patients will shown how to use the acrylic thumb light (RS Magic tricks, Mumbai, India), which willbe placed on their thumb, and instructions will be given to play with it, during the radiographic technique. Once the children learn to use it, they will be asked to take a deep breath and open their mouths for film placement. The intra-oral radiographs will be taken, encouraging the patients to practice what has been instructed. The duration of the intervention is only 2-3 minutes and once.

Inclusion Criteria

Age From	6.00 Year(s)
Age To	13.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
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).	The severity of gagging will be evaluated at base line (single point assessment)

Secondary Outcome

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

Target Sample Size

Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25"

Phase of Trial

N/A

Date of First Enrollment (India)

12/06/2025

Date of Study Completion (India)

22/07/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The increased gag reflex is frequently seen in children and presents problems during various dental procedures including intra-oral radiography. The gagging sensation 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, it will reduce the gagging reflex, thereby helping the pediatric dentist obtain an accurate radiograph with the least faults and less radiation exposure.