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CTRI Number  CTRI/2025/08/092801 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Apelin and Adiponectin levels in patients with periodontal disease and hypertension and its relation to cognition before and after ultrasonic scaling. 
Scientific Title of Study   Apelin and Adiponectin and their relation to periodontal disease, hypertension and cognition before and after scaling and root planning - 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 Chatragadda Swathi 
Designation  Post graduate student 
Affiliation  The Oxford Dental college 
Address  Department of Periodontology, Room No. 3, The Oxford Dental College, 10th milestone, Bommanahalli, Hosur Road, Bengaluru 560068 Karnataka.

Bangalore
KARNATAKA
560068
India 
Phone  9491038581  
Fax    
Email  rachel.swathi@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 Karnataka.

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 Karnataka.

Bangalore
KARNATAKA
560068
India 
Phone  9845252203  
Fax    
Email  nichaniashish@hotmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Room no.3, The Oxford Dental College, 10th milestone, Hosur Rd, Bommanahalli, Bengaluru 560095, Karnataka. India  
 
Primary Sponsor  
Name  Dr Chatragadda Swathi 
Address  Department of Periodontology, Room no.3, The Oxford Dental College, 10th milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka 
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 Chatragadda Swathi  The Oxford Dental college  Department of Periodontology, Room no.3, 10th milestone, Hosur Rd, Bommanahalli, Bengaluru - 560068, Karnataka. India Bangalore KARNATAKA
Bangalore
KARNATAKA 
9491038581

rachel.swathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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 
Comparator Agent  None  None 
Intervention  Scaling and root planing   Salivary and serum Apelin and Adiponectin levels, neuropsychological assessment and clinical parameters will be assessed at baseline and four weeks post scaling and root planing.  
 
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 the previous six months.
2.Patients with a diagnosis of generalized periodontitis as per World Workshop Classification criteria (2017)
3.Patients diagnosed with Hypertension as per the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines (2017).
 
 
ExclusionCriteria 
Details  1.Smokers and alcoholics.
2.Patients with systemic diseases like diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, tumors, autoimmune diseases and renal diseases.
3.Pregnant and lactating females.
4.Any other systemic disease which can alter the course of periodontal disease.
5.Patients on medications like anti-inflammatory drugs, antibiotics and anti-epileptic drugs in the past 6 months.
6.Postmenopausal women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate levels of salivary & serum Apelin and Adiponectin in
individuals with generalised periodontitis and Hypertension. 
At baseline and four weeks
after scaling and root planing 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of scaling and root planing on
periodontal health, hypertension and cognition. 
At baseline and four weeks
after scaling and root planing 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2 
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, a highly prevalent chronic, immune-mediated, inflammatory, infectious disease characterized by hard and soft periodontal tissue destruction, increases the risk of cognitive decline in the elderly. Similarly, periodontitis has been associated with hypertension and the systemic pro-inflammatory state posed by it could partially contribute to a rise in blood pressure (BP). Obesity and related metabolic disturbances including hypertension predict future cognitive decline. Periodontitis promotes inflammation of adipose tissue. Obese patients are in a generalized state of inflammation caused by actions of inflammatory cytokines and adipokines such as adipocytokines.  

Apelin (APLN), an adipocytokine secreted by visceral adipose tissue, is encoded by APLN gene, a preprotein of 77 amino acids. It is expressed in various organs including the brain and low serum levels of apelin have been observed in the mild cognitive impairment (MCI). Apelin is a potent effector that modulates vascular homeostasis and has effects on regulation of blood pressure by direct action on the vascular wall via paracrine effects or by affecting endothelial function. Serum and salivary concentrations of apelin are elevated in periodontitis.

Adiponectin, a 28-kDa protein adipocytokine, is mainly produced and secreted into the circulation by lean adipocytes. Adiponectin crosses the blood–brain barrier and acts as a neuroprotective molecule, with beneficial effects on hippocampal neurogenesis and cognitive function. Adiponectin lowers blood pressure by decreasing renal sympathetic nervous system activity. Serum adiponectin levels and expression of adiponectin receptors in periodontal tissues are decreased in patients with periodontitis. 

Scaling and root planing (SRP) reduces systemic inflammation and exposure to Porphyromonas gingivalis, reduces or delays the development of cognitive decline and causes significant reduction of systolic and diastolic BP. We therefore hypothesized that periodontitis, if positively associated with hypertension & cognition, SRP could lead to improvement in cognition and influence Apelin and Adiponectin levels. Till date, the role of apelin and adiponectin in the pathologic processes linking periodontal disease, hypertension and cognition is unclear. Hence the aim of the study is to correlate levels of salivary and serum apelin and adiponectin in individuals with generalized periodontitis and hypertension and to evaluate the effect of SRP on periodontal health, hypertension and cognition.

 

 
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