| CTRI Number |
CTRI/2022/05/042709 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
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Public Title of Study
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TO FIND AN ASSOCIATION BETWEEN THE BODY MASS INDEX AND UNTREATED DENTAL CARIES PROGRESSION IN 5-15 YEARS OLD SCHOOL CHILDREN OF DAKSHINA KANNADA DISTRICT USING PUFA INDEX |
|
Scientific Title of Study
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CORRELATION OF BODY MASS INDEX TO SEVERITY OF UNTREATED DENTAL CARIES IN 5-15 YEARS OLD SCHOOL CHILDREN OF DAKSHINA KANNADA DISTRICT USING PUFA INDEX |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshni Mathew |
| Designation |
Postgraduate student |
| Affiliation |
AB Shetty memorial institute of dental sciences |
| Address |
AB Shetty Memorial Institute of Dental Sciences,4th Floor,
Department of Pediatric and Preventive Dentistry,
Nitte university, Derlakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8971471587 |
| Fax |
|
| Email |
roshnimathew96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Mathew |
| Designation |
Postgraduate student |
| Affiliation |
AB Shetty memorial institute of dental sciences |
| Address |
AB Shetty Memorial Institute of Dental Sciences,4th Floor,
Department of Pediatric and Preventive Dentistry,
Nitte university, Derlakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8971471587 |
| Fax |
|
| Email |
roshnimathew96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srikala Bhandary |
| Designation |
Professor |
| Affiliation |
AB Shetty memorial institute of dental sciences |
| Address |
AB Shetty Memorial Institute of Dental Sciences,4th Floor,
Department of Pediatric and Preventive Dentistry,
Nitte university, Derlakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9535620371 |
| Fax |
|
| Email |
drsrikalabhandary@nitte.edu.in |
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Source of Monetary or Material Support
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| AB Shetty Memorial Institute of Dental Sciences,4th Floor,
Department of Pediatric and Preventive Dentistry,
Nitte university, Derlakatte,Mangalore |
|
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Primary Sponsor
|
| Name |
AB Shetty Memorial Institute Of Dental Sciences |
| Address |
nitte university, derlakatte,mangalore |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr roshni mathew |
AB Shetty Memorial Institute of Dental Sciences |
4th Floor,
Department of Pediatric and Preventive Dentistry,
Nitte university, Derlakatte,Mangalore
Dakshina Kannada
KARNATAKA |
8971471587
roshnimathew96@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committe-nitte (deemed to be university) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
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Intervention / Comparator Agent
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Inclusion Criteria
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| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1) Children who are willing to participate in the study with parental consent.
2) Children with the presence of at least one pulpally involved/ulcerated/fistulated/abscessed tooth.
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| ExclusionCriteria |
| Details |
1) Caries free children.
2) Children with severe systemic illness or nutritional deficiency.
3) Children with special health care needs.
4) Children on long term medication.
5) Uncooperative children.
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
| There is increase in BMI with increase in severity of untreated dental caries (PUFA/pufa index) among 5-15 years old school children in Dakshina Kannada district. |
6 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| There is decrease in BMI with increase in severity of untreated dental caries (PUFA/pufa index) among 5-15 years old school children in Dakshina Kannada district. |
6 months |
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Target Sample Size
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Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
23/05/2022 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Numerous research has been conducted by various researchers assessing the effect of dental caries using DMFT index on BMI of children. The principle limitation of the deft/DMFT index is that it is unsuccessful in measuring the clinical sequelae of untreated dental carious lesions such as pulpal involvement and dental sepsis. Thus the PUFA/pufa index was developed by Monse B et al in Philippines National Oral Health Survey (2006) to address consequences of untreated carious lesions. Limited research has been conducted on effects of longstanding untreated dental caries on BMI of children. Hence the need for this study.
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