| CTRI Number |
CTRI/2024/04/065686 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the relation between insulin resistance and periodontitis in non-diabetic patients with periodontal disease. |
|
Scientific Title of Study
|
Determination of insulin sensitivity and its correlation to Periodontal Inflamed Surface Area (PISA) and Tumor Necrosis Factor-α (TNF-α) in patients with Periodontitis. |
| 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 Menaka KB |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences. |
| Address |
Department of Periodontics, No.9, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, BELAGAVI, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
09448268812 |
| Fax |
|
| Email |
menakakaralwad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Menaka KB |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences. |
| Address |
Department of Periodontics, No.9, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, BELAGAVI, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
09448268812 |
| Fax |
|
| Email |
menakakaralwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Menaka KB |
| Designation |
Professor |
| Affiliation |
KAHER KLE VK Institute of Dental Sciences. |
| Address |
Department of Periodontics, No.9, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, BELAGAVI, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
09448268812 |
| Fax |
|
| Email |
menakakaralwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE VK Institute of Dental Sciences and KLEs Dr Prabhakar Kore Hospital and Research center |
|
|
Primary Sponsor
|
| Name |
Dr Menaka K B |
| Address |
Department of Periodontics, No.9, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, BELAGAVI 590010,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 Menaka K B |
KLE VK Institute of Dental sciences |
Department of Periodontics, No.9, KAHER KLE VK Institute of Dental Sciences, Nehru Nagar, BELAGAVI 590010,Karnataka
Belgaum
KARNATAKA |
9448268812
menakakaralwad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research & Ethics committee of KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with healthy periodontium
2. Patients diagnosed with periodontitis
3. Patients with no history of any kind of systemic diseases.
|
|
| ExclusionCriteria |
| Details |
1. No previous periodontal treatment.
2. Patients with history of smoking and tobacco chewing
3. Pregnant or lactating women.
4. Patients diagnosed with bleeding disorders.
5. Patients on any kind of medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Homeostasis model assessment of insulin resistance (HOMA-IR)
2. Periodontal Inflamed Surface Area (PISA)
|
Baseline - Sample analyzed at a single point in time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary levels of Tumor Necrosis Factor-α (TNF-α) |
Baseline - sample analyzed at one point in time |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This will be a Observational cross-sectional study conducted in the department of periodontics KLE VKIDS which will enroll a total of 60 patients into 2 groups. Periodontitis will be assessed using PISA and insulin sensitivity will be checked with HOMA-IR index. PISA quantifies the surface of bleeding pocket epithelium and estimates the inflammatory burden as periodontitis causes systemic inflammatory burden through release of inflammatory mediators. the bi-directional link between periodontitis and Diabetes Mellitus is well established, however, studies assessing the link of periodontitis to insulin sensitivity are limited. TNF-alpha is linked to the pathogenesis of Insulin sensitivity and is one of the inflammatory mediators released during periodontitis. Therefore, the present study intends to determine the insulin sensitivity in patients with periodontitis and correlate salivary levels of TNF-alpha. |