| CTRI Number |
CTRI/2025/08/092886 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between non-insulin based insulin resistance indices, weight-adjusted waist index and inflammation in periodontal disease and hypertension |
|
Scientific Title of Study
|
Association between non-Insulin based Insulin resistance indices, Weight-Adjusted Waist index (WWI), systemic inflammation, periodontitis and hypertension- An observational 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 Aparna Rajesh |
| Designation |
Post graduate student |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College,
10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068
Bangalore KARNATAKA 560068 India |
| Phone |
8660025773 |
| Fax |
|
| Email |
aparnatrajesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashish S Nichani |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College,
10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068
Bangalore KARNATAKA 560068 India |
| Phone |
9845252203 |
| Fax |
|
| Email |
nichaniashish@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashish S Nichani |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College,
10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068
Bangalore KARNATAKA 560068 India |
| Phone |
9845252203 |
| Fax |
|
| Email |
nichaniashish@hotmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Department of Periodontology, room number-03, 10th
milestone, Bommanahalli, Hosur road, Bangalore- 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Rajesh |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College,
10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Aparna Rajesh |
The Oxford Dental College, Bangalore |
Department of
Periodontology, Room
no.3, The Oxford
Dental College, 10th
milestone, Hosur Rd,
Bommanahalli,
Bengaluru - 560068 Bangalore KARNATAKA |
8660025773
aparnatrajesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee The Oxford Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have not received any periodontal treatment in previous six months.
2. Patients with a diagnosis of generalized periodontitis as per World Workshop Classification criteria (2017)
3. Patients who are otherwise systemically healthy (no other systemic conditions as per medical history assessment / interview) |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases including diabetes mellitus, hypertension, cardiovascular diseases, rheumatoid arthritis, tumours, autoimmune diseases and renal diseases.
2. Pregnant and lactating females.
3. Any other systemic disease which can alter the course of periodontal disease.
4. Patients on medications including anti-inflammatory drugs, antibiotics and anti-epileptic drugs in the past 6 months.
5. Post-menopausal women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the association between periodontitis, hypertension and insulin resistance at baseline. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the role of non-insulin-based insulin resistance indices, weight-adjusted waist index and systemic inflammation in periodontitis and hypertension at baseline. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
15/09/2025 |
| 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="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
|
Periodontitis is a common
inflammatory disease caused by a dysbiotic biofilm and affects the soft and
hard tissues around teeth. Inflammation is considered an important driver of
vascular dysfunction and is implicated in the development and progression of
hypertension. Recent evidence suggests a possible causal link between
periodontitis and hypertension. In patients with periodontitis, microbial
dysbiosis from increased bacteria in periodontal pockets is related to
metabolic dysfunction and inflammation-induced Insulin resistance (IR). Hyperinsulinemia closely related
to IR activates the renin-angiotensin-aldosterone system, promotes renal sodium
retention and ultimately leads to hypertension. The non-Insulin bases IR indices, including
the Triglyceride index (TyG), Triglyceride to high-density lipoprotein
cholesterol ratio (TG/HDL-C) and metabolic score for insulin resistance index (METS-IR)
have been identified as useful markers for assessing insulin resistance. A
significant association is also present between periodontitis and non-Insulin
based IR indices. The TyG index is acknowledged as the preferred method for
assessing IR in hypertensive individuals; TG/HDL-C ratio and METS-IR are also associated
with a higher prevalence of hypertension. The weight-adjusted waist index (WWI)
provides a more detailed evaluation of central obesity compared to traditional
measures like body mass index (BMI) & waist circumference (WC). Central
obesity, characterized by excess visceral fat, is particularly concerning due
to its strong link to metabolic issues and IR. A direct link has also been
postulated between WWI and the risk of developing hypertension. In periodontitis, bacterial
components or locally produced pro-inflammatory cytokines may enter the
circulation and cause systemic inflammation. Recent evidence implicates oral
microorganisms in the nitrate-nitrite-nitric oxide (NO) pathway and the
pathogenesis of hypertension. The serum inflammatory biomarkers, high
sensitivity C-reactive protein (hs-CRP) and white blood cells (WBCs), can act
as a proxy of systemic inflammation associated with both these diseases. Recent evidence suggests periodontitis, hypertension and IR are closely linked but limited data is available on the nature of the
association. Hence in this cross-sectional study we seek to examine the
correlation between these diseases & to investigate the role of non-insulin-based
IR indices, WWI, and systemic inflammation in otherwise healthy participants
with or without generalised periodontitis and hypertension. |