| CTRI Number |
CTRI/2025/02/081431 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dental behavior prediction of children |
|
Scientific Title of Study
|
Prediction and Profiling of behavior in 4-10 year old children during their first dental visit- A cross sectional 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 |
K Fathima Jumana |
| Designation |
Postgraduate |
| Affiliation |
KSR Institute of dental science and research |
| Address |
No. 5, Department of pediatric and preventive dentistry, KSR Institute of dental science and research Tiruchengode
Namakkal
Namakkal TAMIL NADU 637215 India |
| Phone |
7092797199 |
| Fax |
|
| Email |
jumanakaja98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharath Asokan |
| Designation |
Professor |
| Affiliation |
KSR Institute of dental science and research |
| Address |
No 5, Department of pediatric and preventive dentistry, KSR Institute of dental science and research Tiruchengode
Namakkal
Namakkal TAMIL NADU 637215 India |
| Phone |
|
| Fax |
|
| Email |
asokansharath@ksridsr.edu.in |
|
Details of Contact Person Public Query
|
| Name |
K Fathima Jumana |
| Designation |
Postgraduate |
| Affiliation |
KSR Institute of dental science and research |
| Address |
No 5, Department of pediatric and preventive dentistry, KSR Institute of dental science and research Tiruchengode
Namakkal
Namakkal TAMIL NADU 637215 India |
| Phone |
7092797199 |
| Fax |
|
| Email |
jumanakaja98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Varinder Goyal, Hon. Secretary General, Indian Society of Pedodontics & Preventive Dentistry
Head office -Department of Paediatric & Preventive Dentistry
Guru Nanak Dev Dental College & Research Institute
Sunam-148028, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Indian society of pedodontics and preventive dentistry |
| Address |
A-68, Exotica Villas, Near Asaram Bapu Tiraha, Airport Road, Bhopal- 462036, Madhya Pradesh |
| Type of Sponsor |
Other [Indian society of pedodontics and preventive dentistry] |
|
|
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 Fathima Jumana K |
K.S.R. Institute of Dental Science and Research |
No. 5, Department of pediatric and preventive dentistry, KSR Educational Institutions,
KSR Kalvi Nagar, Kuchipalayam PO, Tiruchengode – 637215 Namakkal TAMIL NADU |
7092797199
jumanakaja98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
First dental visit
Parental consent to take part in the study
Parent who can understand and complete the questionnaire
|
|
| ExclusionCriteria |
| Details |
Children with special health care needs
Incompletely filled questionnaire
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict expected behavior and compare them with actual exhibited behavior |
Before the start of procedure, during and after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare dental fear & anxiety & behavior management problems |
After the procedure from video recording |
|
|
Target Sample Size
|
Total Sample Size="136" Sample Size from India="136"
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)
|
10/03/2025 |
| 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="2" 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: To predict, characterize and compare children’s behavior during their first dental visit at different treatment conditions.Objectives: To predict the behavior of children using behavior prediction scale. To assess the behavior using Frankl, Holst, North Carolina behavior rating scale before, during, after the procedure To compare the assessed and predicted behavior To compare the anxiety of children and behavior management problems exhibited by children
Methodology: 1. Child anxiety is determined using CFSS-DS by parent in the waiting hall 2. Behavior prediction before the procedure: Primary investigator predicts the behavior using Sharath’s behavior prediction scale at the waiting hall. The expected behavior is predicted by the parent using a set of questions after briefing the treatment plan. 3. Procedure is videotaped. Behavior before, during and after the treatment is rated using Frankl, Holst and North Carolina scale by the secondary investigator 4. Child rates the treatment using modified facial image scale after the procedure
Outcome: To predict expected behavior and compare them with actual exhibited behavior. The three most important factors involved in a successful pediatric treatment is: The dentist, the patient and parent/care-taker. So, we aim to factor all these three elements while predicting the dental behavior of the children and profile them.
Clinical Relevance: The quality of treatment is correlated with the child behavior which can be effectively managed if behavior prediction is accurate |