| CTRI Number |
CTRI/2025/10/095587 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Saliva and Blood Tests for Gum Disease: Before and After Treatment |
|
Scientific Title of Study
|
EVALUATION OF SALIVARY AND SERUM INTERLEUKIN -38 AND THROMBOMODULIN LEVELS IN PERIODONTITIS PATIENTS BEFORE AND AFTER NON-SURGICAL PERIODONTAL THERAPY: A CLINICAL AND BIOCHEMICAL 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 Supriti Brahma |
| Designation |
Post Graduate |
| Affiliation |
Department of Periodontology, Room no- 106, SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8638863297 |
| Fax |
|
| Email |
drsupritibrahma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A.V Saravanan |
| Designation |
Professor |
| Affiliation |
Department of Periodontology, Room no- 106, SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944361464 |
| Fax |
|
| Email |
saravana4@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriti Brahma |
| Designation |
Post Graduate |
| Affiliation |
Department of Periodontology, Room no.-106, SRM Kattankulathur Dental College |
| Address |
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8638863297 |
| Fax |
|
| Email |
drsupritibrahma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Supriti Brahma |
| Address |
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Supriti Brahma |
SRM Kattankulthaur Dental College and Hospital |
Department of Periodontology
Room no- 106
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
SRM Kattankulathur Dental College SRM Nagar, Kattankulathur Chengalpattu District Tamil Nadu-603203, India
Kancheepuram
TAMIL NADU |
08638863297
drsupritibrahma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE |
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 |
Non-Surgical Periodontal Therapy |
All participants will receive non-surgical periodontal therapy (scaling and root planing) with oral hygiene instructions. Saliva and blood samples will be collected at baseline and follow-up (1 months) to measure interleukin-38 and thrombomodulin using ELISA. Clinical periodontal parameters will also be recorded before and after therapy. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age- 21 to 60 years of age
Both males and females |
|
| ExclusionCriteria |
| Details |
1. Individuals with systemic illness
2. Pregnant & lactating women
3. History of medications such as antibiotics or anticoagulant therapy for past 6 months
4. Participants with previous periodontal treatment or periodontal surgery for past 6 months
5. Smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in IL-38 and thrombomodulin concentrations (saliva and serum) — measured by ELISA. |
Change in IL-38 and thrombomodulin concentrations (saliva and serum) — measured by ELISA.At baseline and 4 weeks after treatmnet |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical periodontal parameters (measured by calibrated examiner):
Mean probing depth (PD), mean clinical attachment level (CAL), and bleeding on probing (BOP %). |
Time points: Baseline (T0) and 3 months (T1). |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
15/10/2025 |
| 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="1"
Months="0"
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
|
Aim of the study is to evaluate the salivary and serum levels of Interleukin-38 (IL-38) and Thrombomodulin (TM) in patients with periodontitis before and after non-surgical periodontal therapy (NSPT). IL-38, a recently identified anti-inflammatory cytokine, and TM, an endothelial glycoprotein with anticoagulant activity, may play significant roles in periodontal inflammation and healing. By assessing 49 patients with Stage II periodontitis, clinical parameters such as plaque index, gingival bleeding index, probing depth, and attachment level, along with biochemical analysis of IL-38 and TM using ELISA, will be compared pre- and post-therapy. The study seeks to determine whether changes in these biomarkers reflect treatment outcomes, potentially establishing them as novel indicators for monitoring disease activity and therapeutic response in periodontitis. |