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CTRI Number  CTRI/2023/06/053895 [Registered on: 14/06/2023] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   checking the effect of scaling in patients with gum diseases having Diabetes by measuring Maresin ( marker for tissue injury due to infection ) in saliva 
Scientific Title of Study   Effect of Nonsurgical periodontal therapy on the Salivary levels of Maresin as an inflammatory indicator in Periodontitis patients with or without type II Diabetes mellitus - A clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DIVYA M 
Designation  PG student 
Affiliation  K.S.R. Institute of Dental Science and Research  
Address  3, Department of Periodontics KSR Institute of Dental Science and Research KSR Kalvi nagar Thookavadi Tiruchengode

Namakkal
TAMIL NADU
637215
India 
Phone  9514728537  
Fax  4288274745  
Email  divi7812@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr H Esther Nalini 
Designation  Professor & HOD  
Affiliation  K.S.R. Institute of Dental Science and Research  
Address  3, Department of Periodontics KSR Institute of Dental Science and Research KSR Kalvi nagar Thookavadi Tiruchengode

Namakkal
TAMIL NADU
637215
India 
Phone  9486274005  
Fax  4288274745  
Email  hesthernalini78@ksridsr.edu.in  
 
Details of Contact Person
Public Query  
Name  DIVYA M 
Designation  PG student  
Affiliation  K.S.R. Institute of Dental Science and Research  
Address  3, Department of Periodontics KSR Institute of Dental Science and Research KSR Kalvi nagar Thookavadi Tiruchengode

Namakkal
TAMIL NADU
637215
India 
Phone  9514728537  
Fax  4288274745  
Email  divi7812@gmail.com  
 
Source of Monetary or Material Support  
K.S.R. INSTITUTE OF DENTAL SCIENCE AND RESEARCH 
 
Primary Sponsor  
Name  DIVYA M 
Address  Postgraduate student, Department of Periodontics, KSR Institute of Dental Science and Research KSR Kalvi nagar Thookavadi Tiruchengode Namkkal - 637215 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DIVYA M  K.S.R. Institute of Dental Science & Research  Room no : 3 Department of Periodontics ksr kalvi nagar thookavadi - 637215
Namakkal
TAMIL NADU 		 9514728537

divi7812@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KSRIDSR INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator - Not applicable  Comparator - Not applicable 
Intervention  Nonsurgical periodontal therapy (scaling)  Baseline - screening & Saliva collection 3 months post intervention - saliva collection 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  GROUP 1 : Periodontitis without diabetes mellitus
GROUP 2 : Periodontitis with type II diabetes mellitus 
 
ExclusionCriteria 
Details  Systemic disease other than type 2 diabetes mellitus
Antibiotics / Anti- inflammatory drugs for the past 6 months
Smokers
Pregnant women
Lactating mothers
Treatment for periodontal disease within the last 6 months
Involvement in another clinical study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Maresin salivary levels   Baseline and
3 months - post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Probing pocket depth
Clinical attachment level 		 Baseline and
3 months - post intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2023 
Date of Study Completion (India) 08/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [divi7812@gmail.com].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 31-03-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This is a pilot clinical trial. The trial included 22 periodontitis patients and 21 periodontitis patients associated with type 2 diabetes mellitus. I got written informed consent from all the participants. I recorded the clinical parameters and performed scaling and root planing for all patients. I collected 5ml salivary samples before treatment and 1 month after treatment for evaluation of salivary Maresin level. The participants were recalled after 1 month for review. 6 patients from group 1 and 10 patients from group 2 were dropped out due to not showing up for the recall visit. I performed ELISA processing to evaluate the salivary Maresin level before and after treatment.  The results show, decreased salivary maresin levels in both groups before the treatment, indicating the chronicity of both the diseases. whereas, after treatment, the salivary maresin levels were increased which depicts tissue return back to homeostasis and accelerates wound healing. This Maresin biomarker can be used as a chairside diagnostic and prognostic test and also it can be used as a novel host-modulating agent. But further larger clinical trials will ensure the results. 
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