| CTRI Number |
CTRI/2025/10/096325 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Making Dental Visits Easier for Kids: 3D Pop-Up Books or Virtual Games? |
|
Scientific Title of Study
|
Comparison Of 3D Pop-Up Treatment Book Vs Virtual Educational Games In Reduction Of Pediatric Dental Anxiety During Restorative Procedures: A Randomized
Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALAPATI SAI LAKSHMI SUSMITHA |
| Designation |
Post Graduate |
| Affiliation |
MNR Dental college and Hospital |
| Address |
Room no :08,Department of Pedodontics and Preventive dentistry, MNR Nagar, Fasalwadi,Sangareddy,Telangana -502294
Medak
TELANGANA
502294
India |
| Phone |
8247023372 |
| Fax |
|
| Email |
alapatislsusmitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIDHAR MUKTINENI |
| Designation |
Professor and HOD |
| Affiliation |
MNR Dental college |
| Address |
Room no :08,Department of Pedodontics and Preventive dentistry,MNR Nagar, Fasalwadi,Sangareddy,Telangana,
502294
Medak
TELANGANA
502294
India |
| Phone |
9393812081 |
| Fax |
|
| Email |
sridharneni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naseemoon shaik |
| Designation |
Associate Professor |
| Affiliation |
MNR Dental College and Hospital |
| Address |
Room no :08,Department of Pedodontics and Preventive dentistry,MNR Nagar, Fasalwadi, Sangareddy,Telangana -502294
Medak
TELANGANA
502294
India |
| Phone |
8105935678 |
| Fax |
|
| Email |
dr.naseemoonshaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR Dental College and hospital,Room no :08, Department of Pedodontics and Preventive dentistry,MNR Nagar, Fasalwadi, Sangareddy,
Telangana,India -502294 |
|
|
Primary Sponsor
|
| Name |
MNR Dental college and hospital |
| Address |
MNR Nagar, Fasalwadi,Sangareedy, Telangana,502294 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research ICMR under Department of Health Research DHRGrantsupport |
1st floor,IRCS building, 1,Red Cross Rd..,New Delhi-110001. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ALAPATI SAI LAKSHMI SUSMITHA |
MNR Dental college and Hospital |
Room no :08,Department of Pedodontics and Preventive dentistry,MNR Nagar, Fasalwadi, Sangareddy, Telangana, 502294
Medak
TELANGANA |
8247023372
alapatislsusmitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized 3D pop up treatment book |
The 3D pop-up book behavioural intervention will be administered immediately before the dental procedure. Each session will last approximately 10 minutes, during which the operator will engage the child with guided storytelling, interactive page handling, and simple explanations of the treatment steps. An additional 2–3 minutes will be allotted for baseline and post-intervention assessments, including pulse oximeter readings and behavioural scoring. The total duration of the intervention per participant will be approximately 12–15 minutes, with a maximum of 20 minutes for children requiring additional familiarization. |
| Comparator Agent |
Dental simulation games-Baby Panda :Dental care game |
Children will engage with an interactive dental care game:Baby Panda for 8–10 minutes, followed by 2–3 minutes for anxiety assessment and 1–2 minutes for transition to the procedure. The total duration will be 12–15 minutes, with a maximum of 20 minutes if needed. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
First dental visit of the patient
Systemically healthy children.
Children with Frankel’s rating scale 2 or 3. |
|
| ExclusionCriteria |
| Details |
Teeth with abscess, swelling or fistula at the site of injection.
Extensively damaged teeth.
Carious teeth with pre shedding mobility.
Teeth with lesions involving the pulp or extending below the gingiva.
Frankel’s rating scale 1 and 4.
Medically compromised and special needs children. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behavioural response assessed using Frankl Behaviour Rating Scale |
T1 before start of dental procedure baseline, T2 immediately after completion of restorative procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological response heart rate & oxygen saturation using pulse oximeter & Anxiety level Facial Image Scale assessed |
T1 before start of dental procedure baseline, T2 immediately after completion of restorative procedure
|
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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 Applicable |
| 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
|
This randomized interventional clinical trial aims to evaluate the effectiveness of a customized 3D pop-up treatment book and a mobile-based dental care game in reducing dental anxiety and improving cooperative behaviour among children aged 4–6 years during their first dental visit. A total of 128 participants will be randomly allocated into two equal groups, each receiving one of the behavioural modification techniques before a restorative dental procedure. Anxiety levels will be assessed using Frankl Behaviour Rating Scale, Facial Image Scale, and physiological measures (heart rate and oxygen saturation) at four key intervals. The study will compare behavioural outcomes, treatment acceptance, need for additional behavioural interventions, and parental satisfaction between the two groups. The trial is supported by a research grant from Indian Council of Medical Research under Department of Health Research. |