| CTRI Number |
CTRI/2025/03/082598 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Co- relating MMP-8 values and periodontal inflamed surface area in patients with periodontitis before and after scaling and root planing |
|
Scientific Title of Study
|
Estimation of salivary matrix metalloproteinases- 8 (MMP-8) and its correlation to periodontal inflamed surface(PISA) before and after non- surgical periodontal therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Kumari |
| Designation |
Post graduate student |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department of Periodontics, Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08073231684 |
| Fax |
|
| Email |
dr.shalini115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Menaka K B |
| Designation |
Professor and Head of the department |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department of Periodontics, Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08073231684 |
| Fax |
|
| Email |
menakakaralwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Kumari |
| Designation |
Post graduate student |
| Affiliation |
KLE Academy of Higher Education and Research |
| Address |
Department of Periodontics, Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08073231684 |
| Fax |
|
| Email |
dr.shalini115@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, Department no- 9,Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar |
|
|
Primary Sponsor
|
| Name |
Shalini Kumari |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, Nehru nagar, Belagavi, Karnataka |
| 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 |
| Shalini Kumari |
KAHERs KLE VK Institute of Dental Science |
Department of Periodontics, Dept no-9, Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar
Belgaum
KARNATAKA |
08073231684
dr.shalini115@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Chronic periodontitis patients will undergo full mouth ultrasonic scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a minimum of 20 teeth.
Patients with no history of periodontal therapy in the last 6 months.
Subjects with no history of any kind of systemic diseases. |
|
| ExclusionCriteria |
| Details |
Patients with history of smoking and tobacco chewing
Pregnant or lactating women.
Patients on any kind of medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to estimate salivary MMP-8 to PISA in individuals with healthy periodontium and
periodontitis before and after non-surgical periodontal therapy |
salivary MMP-8 and PISA values will be calculated at baseline and non surgical periodontal therapy will be carried out at baseline. After 3 months salivary MMP-8 and PISA will be calculated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2025 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is an interventional study where salivary MMP-8 and PISA values will be estimated in individuals with healthy periodontium and in periodontitis before and after 3 months of non-surgical periodontal therapy. |