| CTRI Number |
CTRI/2019/07/020090 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find the relationship between childhood obesity and dental cavities in children aged 5-12 years. |
|
Scientific Title of Study
|
The association between childhood obesity and dental caries in children aged 5-12 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
C Lalchhandami |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education. |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9077343592 |
| Fax |
|
| Email |
clalchhandami1338@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namratha N Pai |
| Designation |
Asst. Professor |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education. |
| Address |
Department of Dietetics and Applied Nutrition, WGSHA, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9945305773 |
| Fax |
|
| Email |
Namratha.npai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Meghna Sunil Tiwatia |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education. |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9326479470 |
| Fax |
|
| Email |
mtiwatia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
C Lalchhandami Meghna Sunil Tiwatia Sheethal S K |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal- 576104 |
| 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 |
| C Lalchhandami |
Manipal College of Dental Sciences |
Department of Pedodontics and
Preventive Dentistry, MCODS, Manipal-576104
Udupi
KARNATAKA |
9077343592
clalchhandami1338@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All children aged between 5–12 years whose parents/guardians are willing to get their child’s nutritional status assessed are included in the study.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children aged between 5–12 years whose parents/guardians are willing to get their child’s nutritional status assessed are included in the study. Children of all socio-economic status and all genders are
included in the study.
|
|
| ExclusionCriteria |
| Details |
All children who have chronic illness and are on medications are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us to conclude if there is an association between childhood obesity and dental caries. |
Single visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
30/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is done to find the association between childhood obesity and dental caries in children aged 5-12 years using preformed questionnaire. The study will be conducted at Manipal, India. Each participant will be given an education tool regarding obesity and dental caries. Outcome measures of this study is that it will help us to conclude if there is an association between childhood obesity and dental caries. |