| CTRI Number |
CTRI/2026/01/101010 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Using a Dental Game Relaxation Exercises and showing what to do to Help Children Feel Less Anxious at the Dental visit. |
|
Scientific Title of Study
|
Comparison between Dental Simulation Game, Jacobsons Progressive Relaxation
Muscle Technique and Tell-show- Do Technique in Reducing Dental Anxiety in Children During Dental Visit: A Randomized Clinical Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samiksha Umredkar |
| Designation |
Intern |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pedodontics and Pediatric Dentistry, 3rd Floor, Sharad Pawar Dental College Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834387129 |
| Fax |
|
| Email |
samikshau491@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pedodontics and Pediatric Dentistry, 3rd Floor, Sharad Pawar Dental College Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9421163632 |
| Fax |
|
| Email |
drnilimathosar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pedodontics and Pediatric Dentistry, 3rd Floor, Sharad Pawar Dental College Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9421163632 |
| Fax |
|
| Email |
drnilimathosar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nilima Thosar |
Sharad Pawar Dental College |
Dept. of Pedodontics and Pediatric Dentistry, 3rd Floor, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9422163632
drnilimathosar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of dental stimulation game before, during, after dental procedure. |
Use of dental stimulation game before, during, after dental procedure for the child patients. |
| Intervention |
Use of Jacobson muscle relaxation technique before, during, after dental procedure |
Use of Jacobson muscle relaxation technique before, during, after dental procedure for child patients. |
| Intervention |
Use of Tell Show Do Technique before, during, after dental procedure |
Use of Tell Show Do Technique before, during, after dental procedure for child patients. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Children are categorized as definitely positive or
positive ratings, according to Frankel’s behaviour rating scale.
2. Children who are familiar with smartphone games.
|
|
| ExclusionCriteria |
| Details |
1.Children having allergy to local anaesthesia or systemic condition that contraindicates dental extraction.
2. Parental refusal of participation.
3.Mentally ill or mentally retarded children.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental stimulation games, Jacobson’s progressive muscle relaxation technique and tell show do technique will be able to reduce children’s anxiety effectively during dental procedures. |
Assessment will be done at 1 hour of each patient visit. Overall assessment will be done at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A successful paediatric dental practice requires a positive psychological environment for each child. The dental visit will be fearful as well as disturbing for the child. Previous poor medical or dental events can also trigger dental anxiety in children. This may influence the cooperation of children with the required frequency of dental appointments in future. This study will be a randomized control trial study to compare the effectiveness of a dental stimulation game and Jacobson relaxation technique on reducing pain and anxiety during dental visit compared with tell show do technique in paediatric patient with age group 6-13 years.
|