| CTRI Number |
CTRI/2025/09/094164 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Scaling and Root Planing Improves Key Inflammatory Markers in Patients with Metabolic Syndrome and Periodontitis |
|
Scientific Title of Study
|
Efficacy of scaling and root planing on salivary leptin and interleukin 6 levels in patients with metabolic syndrome and periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sohail Ahmed |
| Designation |
Post Graduate |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
| Address |
3-6-164, Flat 307, Block C, Laxminarayana Apartments, Himayathnagar street number 17, Hyderabad
Hyderabad
TELANGANA
500029
India |
| Phone |
9121793913 |
| Fax |
|
| Email |
drsohailahmed@myyahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. P. Veerendranath Reddy |
| Designation |
Professor |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
| Address |
Room no. 101, Dept of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and research centre, Road no. 5, Kamala nagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9866199902 |
| Fax |
|
| Email |
veerureddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sohail Ahmed |
| Designation |
Post Graduate |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
| Address |
3-6-164, Flat 307, Block C, Laxminarayana Apartments, Himayathnagar street number 17, Hyderabad
TELANGANA
500029
India |
| Phone |
9121793913 |
| Fax |
|
| Email |
drsohailahmed@myyahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sohail Ahmed |
| Address |
3-6-164, FLat 307, Block C, Laxminarayana apartments, hIMAYATHNAGAR STREET 17, HYDERABAD 500029 |
| 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 |
| Sohail Ahmed |
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre |
Room 101, Dept of Periodontics, road no 5, Kamalanagar, Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA |
09121793913
drsohailahmed@myyahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Scaling and root planing in patients with metabolic syndrome |
Scaling and root planing of the patients with metabolic syndome will be done. Baseline salivary samples and samples after 3 months will be taken into consideration. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Patients aged between 35-60 years.
•Patients with chronic periodontitis only (bleeding on probing present).
•Probing pocket depth more than 5 mm.
•Clinical attachment loss more than 3 mm.
•Periodontitis patients with metabolic syndrome as per the criteria of the International Diabetes Federation (IDF).
IDF criteria for metabolic syndrome:
The International Diabetes Federation (IDF) defines metabolic syndrome as the presence of central obesity and at least two of the following four factors:
1. Triglycerides: Raised levels of triglycerides, defined as at least 150 mg/dL
2. HDL cholesterol: Reduced levels of HDL cholesterol, defined as less than 40 mg dL for men and less than 50 mg dL for women
3. Blood pressure: Raised blood pressure, defined as at least 130/85 mm Hg
4. Fasting plasma glucose: Raised levels of fasting plasma glucose, defined as at least 100 mg/dL
|
|
| ExclusionCriteria |
| Details |
•Pregnancy or lactation.
•Use of antibiotics or anti-inflammatory drugs in the last 3 months.
•Smokers or alcohol consumers with known addiction.
•Any systemic inflammatory or autoimmune diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will the salivary leptin and interleukin-6 (IL-6) levels will be decreased three months after scaling and root planning? |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters- Plaque index, Probing pocket depth and Clinical attachment levels will be assessed using Williams Probe at baseline and three months after scaling and root planing. |
baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/03/2026 |
| 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 and Objectives
The principal aim is to assess whether scaling and root planing can beneficially impact salivary leptin and IL-6 levels in affected patients. Objectives include evaluating improvements in biochemical markers and clinical periodontal parameters (plaque index, probing pocket depth, clinical attachment loss).
Methods
A parallel arm interventional study will be conducted on 40 patients aged 35–60 years, divided into two groups: one with periodontitis only, and one with both periodontitis and metabolic syndrome. Salivary samples will be collected using the passive drool method and analyzed for leptin and IL-6 levels by ELISA at baseline and three months post-intervention.
Expected Outcomes
The study expects decreased salivary leptin and IL-6 levels three months after scaling and root planing, along with improvements in periodontal health measures. These outcomes will clarify the systemic benefits of periodontal therapy and support integrated care for patients with chronic inflammatory conditions. |