| CTRI Number |
CTRI/2024/12/077932 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparison of cardiovascular biomarker in gingival fluid in diabetic and non-diabetic patients with gingival disease |
|
Scientific Title of Study
|
EFFECT OF PERIODONTAL INTERVENTION ON THE LEVELS OF N TERMINAL PRO BRAIN NATRIURETIC PEPTIDE IN GINGIVAL CREVICULAR FLUID IN DIABETIC AND NON-DIABETIC PATIENTS WITH PERIODONTITIS |
| Trial Acronym |
Effect of periodontal intervention on the levels of N Terminal Pro Brain Natriuretic Peptide in gingival crevicular fluid in diabetic and non-diabetic patients with Periodontitis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dakshina J |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital, Mysuru |
| Address |
D Block, Room No 531, JSS Womens Hostel, JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru - 570015
Mysore
KARNATAKA
570015
India |
| Phone |
7598179358 |
| Fax |
|
| Email |
dakshinajothi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha S |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital, Mysuru |
| Address |
Department of Periodontology, JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru - 570015
Mysore
KARNATAKA
570015
India |
| Phone |
09945376455 |
| Fax |
|
| Email |
dr.anitha.den@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dakshina J |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital, Mysuru |
| Address |
D Block, Room No 531, JSS Womens Hostel, JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru - 570015
Mysore
KARNATAKA
570015
India |
| Phone |
7598179358 |
| Fax |
|
| Email |
dakshinajothi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSSAHER Research grant in house funding
JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru, Karnataka, India - 570015 |
|
|
Primary Sponsor
|
| Name |
JSS Dental College and Hospital Mysuru |
| Address |
JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru, Karnataka, India - 570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dakshina J |
JSS Dental College and Hospital |
Department of Periodontology, JSS Dental College and Hospital, Shivarathreeswara nagara, Bannimantap, Mysuru, Karnataka, India - 570015
Mysore
KARNATAKA |
7598179358
dakshinajothi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital, Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
scaling and root planing and collection of gingival crevicular fluid |
collection of gingival crevicular fluid before scaling and root planing and 3 months post scaling and root planing |
| Comparator Agent |
scaling and root planing and collection of gingival crevicular fluid |
collection of gingival crevicular fluid before scaling and root planing and 3 months post scaling and root planing in diabetic and non-diabetic patients with periodontitis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients within the age 35-50 years
2. Duration of diabetic more than one year
3. Subjects with ≥ 18 completely erupted teeth
4. Subjects with presence of bleeding on probing
5. Probing pocket depth ≥ 5mm
6. Clinical attachment level ≥ 6mm
|
|
| ExclusionCriteria |
| Details |
1. No evidence of systemic diseases other than diabetes as a risk factor for periodontitis
2. Atherosclerotic vascular disease (i.e., CVD, stroke and peripheral artery disease)
3. Arthritis/osteoporosis
4. History of periodontal intervention within the last 6 months
5. Anti-inflammatory and non-steroidal anti-inflammatory therapy within 3 months prior to periodontal assessment
6. Pregnancy
7. Lactation
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between diabetes mellitus and cardiovascular disease as potential risk factors for periodontal disease |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical periodontal parameters, plaque index, gingival index, clinical attachment loss & probing pocket depth before & after scaling & root planing |
3 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
21/12/2024 |
| 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="3"
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
|
NT-ProBNP is a cardiovascular biomarker which is actively detected in periodontal diseases & SRP aids in the improvement in clinical parameters, which may be due to resolution of the inflammatory response and the cessation of periodontal destruction which makes a direct impact on this biomarker and reduces its potential pathogenicity and leads to their lowered concentrations in GCF and serum [1]. In addition diabetic patients have high cardiovascular morbidity and mortality. There are few studies aiming to clarify the role of this NT-ProBNP in diabetic patients. These have shown that in subjects with DM, NT-ProBNP is a direct predictor of adverse outcome and cardiovascular mortality [4]. In light of the above, this research aims to evaluate the role of NT-ProBNP in diabetic and non-diabetic patients with periodontitis before and after SRP [4].This is a comparative, interventional study on diabetic and non-diabetic subjects (satisfying the inclusion and exclusion criteria) visiting OPD in the Dept of Periodontology, JSS Dental College And Hospital, Mysuru, JSS Hospital. Blood investigation reports are obtained. Based on these reports, patients will be categorized into 2 groups: 1. Diabetic patients 2. Non-diabetic patients After complete oral examination, both the groups will be further categorized as periodontally compromised individuals. Details such as demographics, socio-economic, medical information and personal history will be recorded in a preformed case history proforma. Periodontal examination – 1. Plaque index 2. Gingival index 3. Clinical Attachment Loss (CAL) 4. Probing Pocket Depth (PPD) will be done using UNC-15 Probe. Particulars regarding the diabetic status i.e., HbA1C percentage will be collected from the blood investigation reports in diabetic patients.GCF will be collected using micropipettes and samples will be subjected to N Terminal Pro Brain Natriuretic Peptide (NT-ProBNP) test, which will be done in the Department of Biochemistry at JSS Medical College using ELISA kit. These samples will be collected both before SRP and after SRP i.e., after a follow-up period of 3 months. The data obtained will be analyzed.
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