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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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