| CTRI Number |
CTRI/2025/02/081297 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cartoon attire on dental anxiety in pediatric dentistry. |
|
Scientific Title of Study
|
Cartoons to the rescue: A Novel method of driving away dental anxiety. |
| 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 Sonal Mali |
| Designation |
Post graduate student |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
D.Y. Patil university School of Dentistry, sector 7, nerul, Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9969950552 |
| Fax |
|
| Email |
dr.sonalmali97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
Basement, D.Y. Patil university School of Dentistry, sector 7, nerul, Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
D.Y. Patil university School of Dentistry, sector 7, nerul, Navimumbai
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D Y Patil University school of dentistry, Sector 7, Nerul, Navimumbai, Maharashtra, India 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil University school of dentistry Navimumbai |
| Address |
D.Y.Patil University school of dentistry, sector 7, Nerul, Navimumbai, Maharashtra, India 400706 |
| 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 Shilpa S Naik |
D.Y. Patil University School of Dentistry |
Department of Pediatric and Preventive Dentistry, Basement, D Y Patil University school of dentistry, sector 7, nerul Navimumbai
Thane
MAHARASHTRA |
9769600440
shilpa.naik@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional research and ethical board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z012||Encounter for dental examination and cleaning, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cartoon attire |
pediatric dentist wearing cartoon attire while treating children for 20 minutes |
| Comparator Agent |
white clinical apron |
pediatric dentist wearing white coat while treating children |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 Classification.
Children of 4-8 years of age needing oral prophylaxis and restorations.
Children of those parents willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Children whose parents did not give consent.
Children with Frankl behaviour rating 1
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the use of child friendly attire on the dental anxiety of the child in the operatory. |
baseline, during treatment, after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the use of child friendly attire on the behaviour of the child in the operatory. |
baseline, during treatment, |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/03/2025 |
| 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="0"
Months="1"
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
|
Aim: Assess the use of child friendly attire on the dental anxiety and behaviour of the child in the operatory. Materials & Methodology: 60 children 4-8 years of age fulfilling the inclusion criteria will be randomly allocated to either group. Prior to the start of the study, a written consent will be obtained from the parents or guardians after explaining them about the study procedure. Group A (control group) A pediatric dentist dressed in regular medical scrubs will greet the child and escort the child to the chair. Facial image scale (FIS) will be used to assess dental anxiety followed by recording of pulse rate at baseline. Treatment will be started and pulse rate during the procedure will be recorded. Frankl’s Behaviour Rating Scale will also be used to assess the behaviour of the child during treatment. Pulse rate will then be recorded after completion of procedure. Group B (test group) A cartoon costume donned pediatric dentist will greet the child and escort the child to the dental chair. Facial image scale (FIS) will used to assess dental anxiety followed by recording of pulse rate at baseline. Treatment will be started and pulse rate during the procedure will be recorded. Frankl’s Behaviour Rating Scale will also be used to assess the behaviour of the child during treatment. Pulse rate will then be recorded after completion of procedure. |