| CTRI Number |
CTRI/2024/11/076232 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Main outcome of this study is to check the severity of malocclusion and assess its associated factors in the primary dentition of pre school children in vadodara city |
|
Scientific Title of Study
|
Prevalence Of Malocclusion And Assessment Of Its Associated Factors In The Primary Dentition Of Pre-School Children In Vadodara City- A Cross-Sectional Study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KIRTI SHUKLA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
K.M. Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
K.M. Shah Dental College and Hospital
Sumandeep Vidyapeeth
Vadodara
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8556901771 |
| Fax |
|
| Email |
drkirtishukla23nov@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAVNA DAVE |
| Designation |
PG GUIDE |
| Affiliation |
K.M. Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
K.M. Shah Dental College and Hospital
Sumandeep Vidyapeeth
Vadodara
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KIRTI SHUKLA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
K.M. Shah Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
K.M. Shah Dental College and Hospital
Sumandeep Vidyapeeth
Vadodara
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8556901771 |
| Fax |
|
| Email |
drkirtishukla23nov@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and Preventive Dentistry
K.M. Shah Dental College and Hospital
Sumandeep Vidyapeeth
vadodaraa
Gujarat
PIN. 391760 |
|
|
Primary Sponsor
|
| Name |
DR KIRTI SHUKLA |
| Address |
Department of Pediatric and Preventive Dentistry
K.M. Shah Dental College and Hospital
Sumandeep Vidyapeeth |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kirti Shukla |
pre primary schools |
west zone vadodara city
Vadodara
GUJARAT |
08556901771
drkirtishukla23nov@gmail.com |
| dr Kirti Shukla |
pre primary schools |
east zone vadodara city
Vadodara
GUJARAT |
08556901771
drkirtishukla23nov@gmail.com |
| dr Kirti Shukla |
pre primary schools |
north zone vadodara city
Vadodara
GUJARAT |
08556901771
drkirtishukla23nov@gmail.com |
| dr Kirti Shukla |
pre primary schools |
south zone vadodara city
Vadodara
GUJARAT |
08556901771
drkirtishukla23nov@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children 3 to 5 years old without any caries and without any syndromic condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group 3-5 years.
2. Children present in school on the day of
examination.
3. Children whose parents will give the
permission for the examination.
|
|
| ExclusionCriteria |
| Details |
1. Children with any missing teeth or having
any proximal caries.
2. Syndromic and special children.
3. History of orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the prevalence of malocclusion in pre-school children aged 3-5 years.
2. To assess gender variation in malocclusion during primary dentition.
3. To assess intra group variation between 3-4 and 4-5 year old children.
4. To assess the correlation of mother’s education and working status on oral health status of the child.
|
outcome assessed 1 week after study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check correlation between malocclusion and physiological spacing, midline discrepancy, Over-jet, over-bite, open-bite, cross-bite and scissors-bite.
2. To check correlation between second deciduous molar terminal plane, cuspid relation, arch form and malocclusion.
3. To check correlation between malocclusion and associated factors like tongue rest posture, breathing pattern, harmful oral habit(s) if any.
4 . To provide a database for implementing a preventive program at an early age.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
Final Enrollment numbers achieved (Total)= "1100"
Final Enrollment numbers achieved (India)="1100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/11/2024 |
| Date of Study Completion (India) |
09/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It’s a cross sectional study which requires 1100 participants of pre-primary school children from Vadodara city. This study will increase the awareness of importance of deciduous dentition and early intervention to prevent malocclusion, to reduce the ill effects of harmful oral habit(s) in permanent dentition and to provide the baseline data for prevalence of malocclusion and its associated factors in pre-schoolers. |