| CTRI Number |
CTRI/2025/08/093728 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
The Impact of Gum Treatment on Healing Molecules in Saliva |
|
Scientific Title of Study
|
EFFECT OF NON-SURGICAL PERIODONTAL THERAPY ON SALIVARY LEVELS OF MARESIN AND PROTECTIN IN PATIENTS WITH STAGE 2 GRADE B PERIODONTITIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| drsmithashetty@nitte.edu.in |
ClinicalTrials.gov |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi Shukla |
| Designation |
PG Student |
| Affiliation |
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES |
| Address |
Dept. of Periodontology , ABSMIDS, derlakatte, managlore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9871142101 |
| Fax |
|
| Email |
khushishukla0598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Smitha Shetty |
| Designation |
READER |
| Affiliation |
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES |
| Address |
Dept. of Periodontology , ABSMIDS, derlakatte, managlore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845765583 |
| Fax |
|
| Email |
drsmithashetty@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Shukla |
| Designation |
PG Student |
| Affiliation |
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES |
| Address |
Dept. of Periodontology , ABSMIDS, derlakatte, managlore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9871142101 |
| Fax |
|
| Email |
khushishukla0598@gmail.com |
|
|
Source of Monetary or Material Support
|
| A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES A constituent college of NITTE (Deemed to be University) Derlakatte, Mangalore - 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Khushi Shukla |
| Address |
A B Shetty memorial institute of dental sciences , Mnagalore |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Khushi Shukla |
A B SHETTY DENTAL HOSPITAL |
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES MANAGLORE . Department of periodontology, 4th floor
Dakshina Kannada
KARNATAKA |
9871142101
khushishukla0598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES ETHICAL 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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
systemically healthy patients with more than 20 natural teeth present
Pateints with stage 2 grade b periodontitis |
|
| ExclusionCriteria |
| Details |
Patient wth any systemic disease, or with history or drug intake in past 6 months that can affect inflmmatory response
pregnancy or lactating patients
history of smoking
patients with less than 20 natural teeth present |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Salivary levels of Protectin
2. Salivary levels of Maresin |
0- baseline, end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation with clinical parameters , like bleeding on probing , and reduction in pocket probing depth , after non surgical periodontal therapy |
baseline to end of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [khushishukla0598@gmail.com].
- For how long will this data be available start date provided 30-08-2025 and end date provided 27-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
37 study participants reporting to the Department of periodontitcs, A B shetty memorial institutde of dental Sciences, will be recruited for this study. The patients should have stage 2 grade B periodontonitits as per 2017 world worksop classification of periodontal diseases . the pateints hsould be systemically healthy , and not under any medications that can alter the state of inflmmation since 6 months . after obtaing written an doral consent Saliva samples will be collected in a vacutainer from the patients post which will under go routine professional oral prophylaxis and recalled after 4 weeks for evalutation. At the time of evaluation the saliva sample will be collected again. The saliva samples will be immediatedly centrifuged at 3000 rpm, the supernatant is stored at - 60 degree celcius. after 4 months ELISA tests , of these specific markers i.e Protectin and Maresin will be run. Salivary levels will be estimated and analaysed |