| CTRI Number |
CTRI/2024/08/071918 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Animated Pictures and Tell Show Do Affect Childrens Behavior at the Dentist |
|
Scientific Title of Study
|
Effect of Digitalized Previsit Imagery v/s Tell Show Do on behaviour of children in dental operatory |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithula Raj |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajasekar Gunasekaran |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
rajasekarg.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithula Raj |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college and hospitals |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| 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 Mithula Raj |
Saveetha dental college and hospitals |
Clinic 28
Department of pediatric and preventive dentistry
Chennai
TAMIL NADU |
9539655505
mithularaj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digitalized previsit imagery |
a sequence of personalized, animated drawings that introduce child to dental operatory
The child was shown animated images and videos about the dental procedures before the treatment in the waiting room, and after 1 hour, their anxiety was assessed using the Venhams Picture Scale. The respective procedures were then performed. |
| Comparator Agent |
Tell Show Do |
The TELL phase involves an age appropriate explanation of the procedure. The SHOW phase is used to demonstrate a procedure up to the point where the instrument is performed. The DO phase is then initiated and the treatment is performed.The child was explained and demonstrated the dental procedures before the treatment in the waiting room. After 1 hour, their anxiety was assessed using the Venhams Picture Scale, and the respective procedures were then performed. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children who haven’t visited the dental clinic before
Children who need only non invasive procedures like restorations,scaling,sealants |
|
| ExclusionCriteria |
| Details |
Medically compromised children
Children who had visited clinic more than one time
Children in need of invasive procedures like extraction,pulpectomy |
|
|
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 |
| Assessment of anxiety |
Baseline
After 1 hour of behaviour modification |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for procedures
Cooperation during treatment
|
Baseline
After 1 hour of behaviour modification |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
29/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Background Children experience dental anxiety which make dental appointments more difficult.Traditionally this fear was managed by tell show do technique. Recently digitalized solutions like pre visit images,movies helps in reducing anixiety Purpose The purpose of this trial is to evaluate how well tell show do and digitalized pre visit imagery improve behaviour of young dental patients |