| CTRI Number |
CTRI/2024/11/076808 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Advertency and Cognizance about Diabetes and Periodontal Disease Association – A Cross-Sectional Study in Chhattisgarh |
|
Scientific Title of Study
|
Assessment of Awareness toward the Relationship between Diabetes and Periodontitis in the General Population of Chhattisgarh: 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 Shashank Agrawal |
| Designation |
MDS 2nd year student |
| Affiliation |
Government Dental College |
| Address |
Room no 12
Department of Periodontics
Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
7898867987 |
| Fax |
|
| Email |
shashanka202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Gupta |
| Designation |
Prof and Head og Department |
| Affiliation |
Government Dental College |
| Address |
Room no 12
Department of Periodontics
Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9131144870 |
| Fax |
|
| Email |
vinleo76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Agrawal |
| Designation |
MDS 2nd year student |
| Affiliation |
Government Dental College |
| Address |
Room no 12
Department of Periodontics
Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
7898867987 |
| Fax |
|
| Email |
shashanka202@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Raipur Chhattisgarh India 492001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [No Sponcers] |
|
|
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 Shashank Agrawal |
Government Dental College |
Room no 12 Deparment of Periodontics Government Dental College Raipur chhattisgarh
Raipur
CHHATTISGARH |
07898867987
shashanka202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee Government Dental College Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not Applicable |
not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
Patient knows English and Hindi |
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic disease other than diabetes
Patients who cannot read and understand either english and Hindi |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study expects to find that a significant proportion of the population has low awareness of this relationship, indicating a knowledge gap in understanding how diabetes can influence periodontal health and vice versa. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to assess the general awareness of oral hygiene practices among diabetic patients in Chhattisgarh. The study may find that patients with diabetes are either unaware of the importance of periodontal care or do not follow adequate oral health routines, which could exacerbate periodontal disease. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
As Chhattisgarh is relatively undeveloped and the population has a high prevalence of poor oral hygiene practices, smoking, alcohol consumption and diabetes, the risk of periodontitis may be increased. There is a need for a related study on the population of Chhattisgarh as there is less awareness among the people about the interrelationship between diabetes and periodontitis. Hence, the present study aimed to assess the levels of awareness about the relationship between diabetes and periodontitis among the general population of Raipur. In addition, the attitude of general physicians in suggesting that diabetic patients visit a dentist will also be assessed |