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CTRI Number  CTRI/2021/09/036120 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 10/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of anxiety for dental treatment with the IQ levels of children aged between 6-9 years 
Scientific Title of Study   Correlation of dental anxiety measured by Children Drawing: Hospital scale and SEM scale with the Intelligence Quotient levels measured by Binet Kamat Test among children aged 6-9 years 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apurva Mahale 
Designation  Post Graduate Student in Pediatric Dentistry 
Affiliation  Pacific Dental college and Hospital 
Address  Pacific Dental College and Hospital Debari Udaipur Rajasthan

Udaipur
RAJASTHAN
313024
India 
Phone  9049513399  
Fax    
Email  almahale13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Rao 
Designation  Professor and Head  
Affiliation  Pacific Dental college and Hospital 
Address  Department of Pediatric and Preventive Dentistry Pacific Dental College and Hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Apurva Mahale 
Designation  Post Graduate Student in Pediatric Dentistry 
Affiliation  Pacific Dental college and Hospital 
Address  Pacific Dental College and Hospital Debari Udaipur Rajasthan

Udaipur
RAJASTHAN
313024
India 
Phone  9049513399  
Fax    
Email  almahale13@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Pacific Dental College and Hospital, Department of Pediatric and preventive dentistry 
 
Primary Sponsor  
Name  Dr Apurva Mahale 
Address  Pacific Dental College and hospital Debari Udaipur 313024 
Type of Sponsor  Other [SELF] 
 
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 
Apurva Mahale  Pacific Dental College and Hospital  Room No. 9, Department of Pediatric and Preventive Dentistry
Udaipur
RAJASTHAN 		 9049513399

almahale13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pacific Dental college and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children without any compromised physical and mental health history 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Children without previous dental treatment experience
2. Children with carious primary teeth which required pulp therapy and restorative treatment
3. Parents and children who give written informed and verbal informed consent respectively for their participation in the study
4. Children who accept to draw a picture.
 
 
ExclusionCriteria 
Details  1. Children with a compromised physical and mental health history
2. Children who already received dental treatments
3. Children who only needed preventive treatments
4. Children who reject to draw a picture
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
There should be a correlation between Dental Anxiety and Intelligence Quotient.  Immediately after the collection of results from the psychologist 
 
Secondary Outcome  
Outcome  TimePoints 
comparision of Sound Eye Motor Test with Childrens drawing :Hospital Scale  Immediately after Collection of the data 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   02/09/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [almahale13@gmail.com].

  6. For how long will this data be available start date provided 26-06-2021 and end date provided 26-03-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
Introduction:
Dental anxiety is one of the major problems faced by pediatric dentists all over the world. The aim of this study is to correlate Intelligence Quotient measured by Binet Kamat Test and Dental Anxiety measured by Children’s Drawing Hospital Scale and Sound Eye Motor Test in the children aged 6-9 years.

Methodology:
       Intelligence quotient of the patient will be measured after the treatment allotment. Then the Pulp therapy will be done as per intra oral Diagnosis. The child will be given drawing material and asked to draw a picture of a person in Dental Clinic. The Frankel Behavior and Sound Eye Motor test will be assessed during the treatment. The child’s drawing will be assessed by a pediatric dentist who’s blind to the score of Sound Eye Motor test and Frankel Behavior and Intelligent Quotient. The drawing will be again assessed by a psychologist who’s blind to all the scores. Correlation between Intelligent Quotient and Dental Anxiety will be assessed after collection of data.

 Conclusion:


Statistical significant positive correlation was found when IQ was correlated with Dental anxiety when calculated by psychologist, which shows Intelligence Quotient could be related to Dental anxiety

 
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