| CTRI Number |
CTRI/2021/12/038618 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
12/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Self-reported Oral Health measures among adults in Udupi city |
|
Scientific Title of Study
|
Validation of Self-reported Oral Health in population of Udupi district |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyana Chakravarthy Pentapati |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room number 8, department of Public Health Dentistry, Manipal College of Dental Sciences, Madhav Nagar, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9916036303 |
| Fax |
|
| Email |
drkalyan81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalyana Chakravarthy Pentapati |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room number 8, department of Public Health Dentistry, Manipal College of Dental Sciences, Madhav Nagar, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
9916036303 |
| Fax |
|
| Email |
drkalyan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soniya Gupta |
| Designation |
Intern |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room number 8, department of Public Health Dentistry, Manipal College of Dental Sciences, Madhav Nagar, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9575855784 |
| Fax |
|
| Email |
soniyagupta2627@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Madhav Nagar, Manipal - 576104, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
P Kalyana Chakravarthy |
| Address |
Room number 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal |
| 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 |
| P Kalyana Chakravarthy |
Manipal College of Dental Sciences |
Room number 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9916036303
drkalyan81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Apparently healthy patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Dental out-patients who are willing to participate in the study and who can read and write Kannada will be included |
|
| ExclusionCriteria |
| Details |
Patients who are having urgent oral conditions (pain, abscess or swelling) and patients who are unable to comprehend in Kannada will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity of the questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Validity of the questionnaire with respect to demographic characterstics |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/12/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission to conduct the study will be obtained from institutional review board and ethics committee. Informed consent would be obtained from all the participants who are willing to participate. Participants will be given a self-administered questionnaire in Kannada. Clinical oral examination would be done by trained and calibrated examiner. |