| CTRI Number |
CTRI/2024/02/063291 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Screening of undiagnosed diabetes mellitus and pre-diabetes by assessing sugar (HbA1c) level in patients with periodontitis of central Maharashtra. |
|
Scientific Title of Study
|
Screening of undiagnosed diabetes mellitus and pre diabetes by assessing HbA1c level in patients with periodontitis of central Maharashtra - 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 Disha Dhannawat |
| Designation |
PG Student |
| Affiliation |
Dr HSRSM Dental college and Hospital , Hingoli |
| Address |
Department of Periodontics, Dr HSRSM Dental college and hospital, Akola bypass, Hingoli. 431513
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9028368731 |
| Fax |
|
| Email |
drdishaperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subodh Gaikwad |
| Designation |
Associate Professor |
| Affiliation |
Dr HSRSM Dental college and Hospital , Hingoli |
| Address |
Department of Periodontics Dr HSRSM Dental college and hospital, Akola bypass, Hingoli. 431513
Hingoli
MAHARASHTRA
431513
India |
| Phone |
7709063683 |
| Fax |
|
| Email |
drsubodhgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Dhannawat |
| Designation |
PG Student |
| Affiliation |
Dr HSRSM Dental college and Hospital , Hingoli |
| Address |
Department of Periodontics Dr HSRSM Dental college and hospital, Akola bypass, Hingoli. 431513
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9028368731 |
| Fax |
|
| Email |
drdishaperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr HSRSM Dental college and hospital, Hingoli |
|
|
Primary Sponsor
|
| Name |
Dr Disha Dhannawat |
| Address |
PG Hostel Dr HSRSM Dental college and hospital,Akola bypass, Hingoli431513 |
| 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 Disha Dhannawat |
Dr HSRSM Dental college and Hospital , Hingoli |
Department of Periodontics,Dr. HSRSM Dental college and hospital , Akola bypass, Hingoli.431513
Hingoli
MAHARASHTRA |
9028368731
drdishaperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. HSRSM Dental college and hospital ethics committee , Hingoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z728||Other problems related to lifestyle, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with periodontitis.
|
|
| ExclusionCriteria |
| Details |
Known patient of diabetes.
Systemic disease affecting immunological health.
Pregnant and lactating patients.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c level |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diabetes mellitus or prediabetes |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
10/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim : Screening of undiagnosed diabetes mellitus and pre diabetes by assessing HbA1c level in patients with periodontitis of Central Maharashtra.Material methodology: It is an in-vivo cross sectional study with sample size of 160 patients between the age group of 25-65 years suffering from periodontitis (according to 2017 classification of periodontitis).Known patients of diabetes and with systemic disease affecting immunological health will be excluded from the study. Also pregnant and lactating female patients will be excluded from the study.
Expected outcome: Patients suffering from periodontitis can be either prediabetic or undiagnosed diabetic ( with increased HbA1c level) as there is a proven two way relation between diabetes and periodontitis.
Conclusion: patients can be made aware of the pre diabetic or undiagnosed diabetic condition those who are suffering from periodontitis.
|