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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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