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CTRI Number  CTRI/2023/09/057992 [Registered on: 25/09/2023] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Reasons for Children Frequent Attendance At The Dental Clinic In Andhra Pradesh West Godavari District 
Scientific Title of Study   Impact Of Various Factors Affecting Childrens Regular Attendance To Dental Hospital In West Godavari District Andhra Pradesh  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amaradri Sravya 
Designation  Student 
Affiliation  Vishnu Dental College 
Address  Department Of Pedodontics, Vishnu Dental College, Bhimavaram, West Godavari district.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  8008686092  
Fax    
Email  amaradrisravya9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinay Chandrappa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department Of Pedodontics, Vishnu Dental College, Bhimavaram, West Godavari district.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9666404455  
Fax    
Email  vinaychandrappa@vdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  Vinay Chandrappa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department Of Pedodontics, Vishnu Dental College, Bhimavaram, West Godavari district.


ANDHRA PRADESH
534202
India 
Phone  9666404455  
Fax    
Email  vinaychandrappa@vdc.edu.in  
 
Source of Monetary or Material Support  
Department of pedodontics ,Vishnu Dental College, vishnupur, bhimavaram, 534202 
 
Primary Sponsor  
Name  sravya amaradri 
Address  II MDS,DEPARTMENT OF PEDODONTICS, room number 5, VISHNU DENTAL COLLEGE,BHIMAVARAM,WEST GODAVARI DISTRICT,ANDHRAPRADESH,PIN CODE:534202 
Type of Sponsor  Other [Self funding] 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SRAVYA AMARADRI  vishnu dental college  Department of pedodontics,Room No 5 Vishnu dental college, Vishnupur, Bhimavaram 534202
West Godavari
ANDHRA PRADESH 
8008686092

amaradrisravya9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,VISHNU DENTAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1Children whose parents are willing to give the consent.
2Co-operative children
 
 
ExclusionCriteria 
Details  Children participating in other studies.
Children with systemic illness and special health care needs
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Facilitators and barriers in regular dental attendance
 
at 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="1274"
Sample Size from India="1274" 
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)   16/10/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM: To investigate various factors affecting regular attendance of the children to dental hospital in West Godavari district, Andhra Pradesh.

OBJECTIVES : To assess various facilitators and barriers affecting children’s regular attendance to dental hospital.

 METHODOLOGY: Children aged 3–12 years old who visit the Vishnu Dental College Outpatient Department of Pedodontics and Preventive Dentistry and whose parents have signed the consent form will be included in the study. A validated self-administrated questionnaire written in English and local language (Telugu) will be given to parents to obtain information. The questionnaire includes general questions such as the child’s age, gender, and frequency of dental visits in the previous 12 months. It is further categorised into five domains like sociodemographic factors (socioeconomic status of parent, proximity of dental clinic), child factors (child’s past dental experience, fear and anxiety of child when visiting dentist), parent factors (attitude of parent towards dental treatment, knowledge of parent about child oral health),self-supported oral health care and behaviour factors (oral hygiene aids, consumption of sugary foods) and other factors that include time factor, financial factor, reason for visit, need for dental visit). Prior to the obtaining of information, a brief view of the reason for conducting the questionnaire is explained to the parent.

 
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