| 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
|
|
|
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
|
|
|
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.
|