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
|
|
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
|
|
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. |