| CTRI Number |
CTRI/2018/05/014205 [Registered on: 29/05/2018] Trial Registered Prospectively |
| Last Modified On: |
23/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relation between food and tooth decay in disabled children in Coorg .Karnataka. |
|
Scientific Title of Study
|
Dental caries status and diet analysis in differently abled children of Coorg Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAJNA K P |
| Designation |
Post graduate student |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of pedodontics and preventive dentistry
Coorg institute of dental sciences
kk campus
Maggula village
Virajpet Coorg
Sajnas
Pookkayil post
Naduvilangadi
Tirur
Malappuram-Kerala
Kodagu
KARNATAKA
571218
India |
| Phone |
8296780070 |
| Fax |
|
| Email |
sajnahassan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bobby Wilson |
| Designation |
Reader |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of pedodontics and preventive dentistry
Coorg institute of dental sciences
KK campus
Maggula village ,
Virajpet
Kodagu
KARNATAKA
571218
India |
| Phone |
9740637549 |
| Fax |
|
| Email |
bobbykandathil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bobby Wilson |
| Designation |
Reader |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Department of pedodontics and preventive dentistry
Coorg institite of dental sciences
kk campus
Maggula village
Virajpet
Coorg
Kodagu
KARNATAKA
571218
India |
| Phone |
9740637549 |
| Fax |
|
| Email |
bobbykandathil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences,kk campus,Maggula village, Virajpet, Coorg Karnataka |
|
|
Primary Sponsor
|
| Name |
SAJNA KP |
| Address |
Coorg institute of dental sciences
KK campus
Maggula village
Virajpet
|
| Type of Sponsor |
Other [Self financing] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Prabha |
Cheshire homes |
po box no 93
Polibetta-571215
south Kodagu
Kodagu
KARNATAKA |
08274-251876
cheshirehomesindiacoorg@gmail.com |
| MrsMeena Cariappa |
Kodagu Vidyalaya -opportunity school |
Siddapur road
Madikeri-571201
Kodagu
KARNATAKA |
08272-225920
coovidya@yahoo.com |
| Mrs Ganga Changappa |
Swastha center for Special education and rehabilitation |
po box no 39
Madapur road
Suntikoppa 571237
Kodagu
KARNATAKA |
08276262502
swastha@tatacoffee.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CHESIREHOME |
Approved |
| institutional review board |
Approved |
| KODAGUVIDYALAYA |
Approved |
| SWASTHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
DIFFERENTLY ABLED CHILDREN WITHIN THE AGE OF 3- 20 YRS , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Subjects attending the special schools in Coorg
Subjects who are differently abled
Subjects under the age group of 3-20 yrs.
|
|
| ExclusionCriteria |
| Details |
Subject who is not cooperative.
Subjects who are above the age of 20 years and below 3 years.
Subjects who are not differently abled
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DENTAL CARIES STATUS |
SINGLE POINT-FIRST VISIT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/06/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children with disabilities may have marked oral pathologies either because of their actual disability or for other medical, economic or social reasons or even because their parents find it difficult to carry out proper oral hygiene. Although numerous studies have documented the oral health status of children with special oral health care needs, in a developing country like India further research in this field is required. This study is therefore intended to determine the dental caries status and the nutritional status among differently abled children attending the special schools in Coorg in Karnataka state. AIMS AND OBJECTIVES OF THE STUDY • To evaluate dental caries status of special children in Coorg, district. • To analyze the dietary habit of special children in Coorg, district. SOURCE OF DATA Special children who are attending the school for special need in Coorg district METHOD OF COLLECTION OF DATA Special children aged between 3 to 20 years who are attending the school of special needs in Coorg except those in the exclusion criteria. – First phase of sampling Permission from the concerned school management will be taken prior to the study. Informed consent will be obtained individually from the care giver or the parent of the child . All subjects will be examined by a single clinical examiner, at the special schools under natural light, with
participants in sitting position. For each subject, the following data will be collected: name, age, sex, height, weight, medical history .Dental caries examination will be carried out using a mouth mirror and CPITN probe. The total number of decayed, missing and filled primary and permanent teeth (dmft, DMFT) will be recorded for each patient. A 7 day diet assessment chart will be obtained from each participant with the help of their care taker, which will be assessed by a dietician.
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