| CTRI Number |
CTRI/2025/03/083126 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral cancer awareness survey |
|
Scientific Title of Study
|
Oral cancer awareness in geriatric population: knowledge and
perception survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Kapoor |
| Designation |
student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department number 1, Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal, Madhav Nagar, 576104, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9910533391 |
| Fax |
|
| Email |
radhikakapoor2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vathsala |
| Designation |
reader |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
department number 1, Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal, Madhav Nagar, 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9742160484 |
| Fax |
|
| Email |
vathsala.mcods@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vathsala |
| Designation |
reader |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
department number 1, Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal, Madhav Nagar,576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9742160484 |
| Fax |
|
| Email |
vathsala.mcods@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal, Madhav Nagar, 576104, Karnataka |
|
|
Primary Sponsor
|
| Name |
Radhika Kapoor |
| Address |
Room no. 308, NIH-A block, MAHE hostels, Manipal, Madhav Nagar, 576104, 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 Vathsala |
Department number 1, Oral Medicine and Radiology |
Manipal College of Dental Sciences, Manipal, Madhav Nagar, Karnataka
Udupi
KARNATAKA |
97421 60484
vathsala.mcods@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients who give consent to participate in the study and patients who are 60 years and above visiting the Department of Oral Medicine and Radiology. |
|
| ExclusionCriteria |
| Details |
patients below 60 years of age.
patients who do not give consent to participate. |
|
|
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 understand the knowledge and perception
about oral cancer amongst the geriatric population. Studying and evaluation of all these factors
will help to plan out awareness sessions to these population. |
baseline-cross-sectional |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
indirect benefits will be obtained via which evaluation & deep understanding of the
situation of the geriatric population’s knowledge & perception can be understood & further
improvement of the quality of the oral cancer care units & awareness can take place. |
baseline-cross-sectional |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/04/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The survey will be conducted in the Oral Medicine and Radiology department of MCODS, Manipal. Patients who are 60 years or above will be considered in this study, after their consent. The patient’s data will be recorded by the PI, including the patient’s demographic details like name, age, sex. Patients demographic details, oral hygiene practices, dental status and their knowledge and perception about oral cancer will be assessed and evaluated via a questionnaire. |