| CTRI Number |
CTRI/2017/03/008190 [Registered on: 23/03/2017] Trial Registered Prospectively |
| Last Modified On: |
23/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
oral health of orphan children |
|
Scientific Title of Study
|
Evaluation of oral health related quality of life among institutionalized orphan children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KL Girish Babu |
| Designation |
Professor and Head |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Department of Dentistry, Room no 193,SC Hospital, Hassan Institute of Medical Sciences
Hassan- 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KL Girish Babu |
| Designation |
Professor and Head |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Department of Dentistry, Room no 193,SC Hospital, Hassan Institute of Medical Sciences
Hassan- 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KL Girish Babu |
| Designation |
Professor and Head |
| Affiliation |
Hassan Institute of Medical Sciences |
| Address |
Department of Dentistry, Room no 193,SC Hospital, Hassan Institute of Medical Sciences
Hassan- 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9845340753 |
| Fax |
|
| Email |
docgirish77@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr KL Girish Babu |
| Address |
Department of Dentistry, Room no 193,SC Hospital, Hassan Institute of Medical Sciences
Hassan- 573201,Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr KL Girish Babu |
Hassan Institute of Medical Sciences |
Department of Dentistry, Room no 193,SC Hospital, Hassan Institute of Medical Sciences
Hassan- 573201
Hassan
KARNATAKA |
9845340753
docgirish77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
 Normal, healthy, co-operative children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal, healthy, co-operative children
2. Children aged 6-14 years
3. Children residing in orphanages from the age of 6 years
|
|
| ExclusionCriteria |
| Details |
1. Children who are not willing to participate.
2. Medically compromised children.
3. Children with physical disability.
4. Children with mental disability.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study will help us to know the oral health related quality of life and dental caries status among institutionalized orphan children. |
The outcome will be assessed within the sixth month of the study duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
20/04/2017 |
| 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="5"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non-yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Written permission
will be taken from the authorities of orphanages to conduct the study. Procedure of the study will be explained to
all children. One hundred children
willing to voluntarily participate in the study will be included. Written
informed consent will be taken from selected children.
Data
on oral health related quality of life will be collected by personal interviews
by a single investigator. The oral health related quality of life will be
assessed according to Jokovic et al.
On
the day of oral examination, prior to examination, each child will be asked to
rinse the mouth thoroughly with plain water. Following, each child will be made
to sit upright on an ordinary chair. Oral examination will be done in an
adequate natural light with the help of mouth mirror and CPI probe. Dental
caries status will be assessed using WHO criteria. A
single investigator, who will be trained and calibrated in the department of
Dentistry, Hasssan Institute
of Medical Sciences, will conduct the clinical examination of each
child and record the dental caries status.
The data obtained
will be tabulated and subjected to statistical analysis.
|