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CTRI Number  CTRI/2024/03/064337 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Local Application of Flax Seed Gel for treatment of gum disease. 
Scientific Title of Study   Evaluation Of Clinical Periodontal Parameters And Pro-Resolvin Mediators Eicosapentanoic Acid (Epa) And Docosahexaenoic Acid (Dha) In Gingival Crevicular Fluid (Gcf) With Flax Seed Extract Gel As Local Drug Delivery In Treatment Of Stage 2 And Stage 3 Periodontitis Patients: A Randomised Controlled Trial 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jisha S Raj 
Designation  Post Graduate Student 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore - 560078

Bangalore
KARNATAKA
560078
India 
Phone  8951512022  
Fax    
Email  jishasheelaraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Savita A. M 
Designation  Professor and Head 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore - 560078

Bangalore
KARNATAKA
560078
India 
Phone  9845433660  
Fax    
Email  savitaam@dscds.edu.in  
 
Details of Contact Person
Public Query  
Name  Jisha S Raj 
Designation  Post Graduate Student 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore - 560078

Bangalore
KARNATAKA
560078
India 
Phone  8951512022  
Fax    
Email  jishasheelaraj@gmail.com  
 
Source of Monetary or Material Support  
Jisha S Raj Dayananda Sagar College of Dental Sciences Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru - 560078  
 
Primary Sponsor  
Name  Jisha S Raj 
Address  Dayananda Sagar College of Dental Sciences Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru - 560078 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research  Indian Council of Medical Research, Ansari Nagar, New Delhi - 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jisha S Raj  Dayananda Sagar College of Dental Sciences  Room 402, Department of Periodontics, Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru - 560078
Bangalore
KARNATAKA 		 8951512022

jishasheelaraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Dayananda Sagar College of Dental Sciences  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 
Intervention  Local drug delivery of Flax seed extract gel  A single application of approximately 2 mg of Flax seed extract gel will be delivered into periodontal pockets of Maxillary teeth following Scaling and Root Planing (SRP) at baseline. The frequency of application is only once and total duration of procedure (SRP) and gel application is approximately 45 minutes. 
Comparator Agent  Scaling and Root Planing (SRP) only  Standard therapy of Scaling and Root Planing (SRP) shall only be performed. The frequency is only once at baseline and total duration of procedure is approximately 45 minutes. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Stage 2 and Stage 3 periodontitis in the age group of 25-60 years with a minimum of a total of 24 natural teeth.
2. Sites having pocket probing depth (PPD) of ≥5 mm and clinical attachment loss (CAL) of ≥3mm in the maxillary teeth.
 
 
ExclusionCriteria 
Details  1. Patients suffering from any form of systemic diseases.
2. Patients currently on antibiotic/anti-inflammatory therapy, steroids or hormonal therapy within the past 6 months.
3. Patients with history of any dental therapy in the past 14 days.
4. History of allergy in using any oral hygiene products.
5. Patients with oral abusive habits such as smoking , consumption of alcohol or tobacco or parafunctional habits (like bruxism and grinding of teeth)
6. Pregnant and lactating patients
7. Patients on a diet rich in omega fatty acids.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index score (PI), Gingival index score(GI), Probing pocket depth(PPD) and Clinical attachment level (CAL) and levels of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA)   Baseline, 1 month and 3 months for all the parameters 
 
Secondary Outcome  
Outcome  TimePoints 
Allergic reactions, if any  Baseline 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   Phase 3 
Date of First Enrollment (India)   28/03/2024 
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="0"
Months="3"
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 - 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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [jishasheelaraj@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomised controlled parallel group trial done to assess the pro-resolvin efficacy of indigenously formulated flax seed extract in the form of biodegradable gel when administered as a local drug delivery (LDD) agent in the treatment of stage 2 and stage 3 periodontitis by measuring the resolvins, EPA and DHA. The study will be conducted on out patients reporting to the Department of Periodontics, Dayananda Sagar College of Dental Sciences, Bengaluru. The primary outcome measures will be Plaque Index (PI), Gingival Index (GI), Probing pocket depth (PPD) and Clinical attachment level (CAL) and levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The total sample size will be 26 with each group containing 13 subjects. The time period required for the study will be 3 months. 
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