| CTRI Number |
CTRI/2023/12/060923 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of oral health status of Preschool children and its impact on oral health related quality of life |
|
Scientific Title of Study
|
"A study to assess the oral health status of preschool children and its impact on oral health related quality of life (OHRQoL) in tertiary care hospital, AIIMS Bhubaneswar." |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swaraj Suman |
| Designation |
MSc. Nursing Student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department: College of Nursing,
Room No 109
AIIMS Bhubaneswar,
Sijua, Patrapada, PO- Dumduma, Odisha
Khordha
ORISSA
751019
India |
| Phone |
8709926825 |
| Fax |
|
| Email |
swarajsumanbgp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha P Shetty |
| Designation |
Professor-Cum-Principal |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department: College of Nursing,
Room No 109
AIIMS Bhubaneswar,
Sijua, Patrapada, PO- Dumduma, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9448770302 |
| Fax |
|
| Email |
nurs_asha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha P Shetty |
| Designation |
Professor-Cum-Principal |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department: College of Nursing,
Room No 109
AIIMS Bhubaneswar,
Sijua, Patrapada, PO- Dumduma, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9448770302 |
| Fax |
|
| Email |
nurs_asha@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha,751019 |
| Type of Sponsor |
Government medical college |
|
|
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 ASHOK Kumar Jena |
PEDIATRIC OPD and Immunization Clinic, AIIMS Bhubaneswar |
PEDIATRIC OPD and Immunization Clinic, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha, 751019
Khordha
ORISSA |
9438884077
dent_ashok@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preschool children age 3-5 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with age group between 3 to 5 years.
Parents and caregiver who signed the informed consent. |
|
| ExclusionCriteria |
| Details |
1.Children with Mental retardation.
2.Children with Neurological Problems
3.Children with major systemic illness.
4.Children with syndromes
5.Children with orofacial cleft.
6.Children with lack of manual dexterity.
7.Children with congenital dental malformations.
8.Children with Calcium and Phosphate metabolism disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral health of preschool children. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral health related quality of life of preschool children & family. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
10/01/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is cross-sectional study design to assess the oral health
status of preschool children and its impact on oral health related quality of
life in tertiary care hospital, AIIMS Bhubaneswar.
This study will be conducted in Paediatric OPD and immunization Clinic
of AIIMS Bhubaneswar.
The Objectives is to assess oral health of preschool children and oral
health related quality of Life.
Clinical oral examination of children will be performed by trained
dentist in Dental OPD, AIIMS Bhubaneswar and Questionnaire Survey will be done
related to oral health, habits, and ECOHIS scale assessment.
Prior Permission will be taken from Principal, College of Nursing,
Medical Superintendent, And HOD/Unit, AIIMS Bhubaneswar.
Informed Consent will be taken from parents and confidentiality will be
maintained. |