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CTRI Number  CTRI/2022/11/047236 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Injectable autologus platelet concentrate as an adjunct to periodontal flap surgery in the management of periodontitis 
Scientific Title of Study   Injectable-platelet rich fibrin (i-prf) as an adjunct to open flap debridement (ofd) in the management of periodontal osseous defects not indicated for regenerative therapy :a randomized controlled 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  Dr Keerthana Varma KC 
Designation  Post Graduate Student 
Affiliation  Goverment Dental College , Kottayam 
Address  Department of Periodontics Goverment Dental College Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  7510448235  
Fax    
Email  keerthanavarma95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Baiju RM 
Designation  Additional Professor 
Affiliation  Goverment Dental College , Kottayam 
Address  Department of Periodontics Goverment Dental College Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  9447279605  
Fax    
Email  baijurm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Keerthana Varma KC 
Designation  Post Graduate Student 
Affiliation  Goverment Dental College , Kottayam 
Address  Department of Periodontics Goverment Dental College Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  7510448235  
Fax    
Email  keerthanavarma95@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics Government Dental College Kottayam 
 
Primary Sponsor  
Name  Dr Keerthana Varma KC 
Address  Department of Periodontics ,Government Dental College , Gandhinagar PO Kottayam ,686008 
Type of Sponsor  Other [self] 
 
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 
Dr Keerthana Varma KC  Government Dental College , Kottayam  Department of Periodontics Government Dental College , Gandhinagar PO Kottayam 686008
Kottayam
KERALA 		 7510448235

keerthanavarma95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Intervention  Adjunctive injectable platelet rich fibrin (i PRF ) application  In addition to the procedures undertaken for the control group , the test group will receive adjunctive i PRF application along with open flap debridement at the time of periodontal flap surgery.Periodontal parameters will be evaluated at the baseline and at 3 months and 6 months during patient revaluation. 
Comparator Agent  Open flap debridement  The control group will receive open flap debridement alone in the treatment of periodontal osseous defects not indicated for regenerative therapy.Periodontal parameters will be evaluated at the baseline and at 3 months and 6 months during patient revaluation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Adults above 18years diagnosed with periodontitis (according to AAP,2017 classification)
with residual probing pocket depth (PPD) ≥ 5 mm after step 1 and 2 therapy (non surgical
phase) in at least two adjacent interproximal sites in either of the jaws
2) Systemically healthy subjects
3) Deep pockets associated with horizontal bone defects that are not indicated for regenerative
therapy
4) Full Mouth Bleeding Score ≤ 30 % & Full Mouth Plaque Score ≤ 20%
 
 
ExclusionCriteria 
Details  1) Current tobacco users
2) Subjects taking medications affecting the periodontium (Bisphosphonates ,Calcium channel
blockers ,cyclosporine ,phenytoin, steroids)
3) Pregnancy or lactation
4) Antibiotic medication in the last 3 months
5) Grade II/III furcation involvement
6) Infra bony defects that are indicated for resective or regenerative therapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing pocket depth reduction  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)Clinical attachment gain
2)Gingival recession
3)Pocket closure 		 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/11/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Clinical Study Report

  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 [keerthanavarma95@gmail.com].

  6. For how long will this data be available start date provided 30-11-2024 and end date provided 30-11-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Periodontitis is a chronic inflammatory disease that causes destruction of the tooth-attachment apparatus. The aim of regenerative periodontal therapy is to restore the structure and function of the periodontium. The objective of this prospective intervention trial is to assess the effectiveness of adjunctive i PRF application along with open flap debridement in the treatment of periodontal osseous defects not indicated for regenerative therapy. Otherwise healthy adults with moderate to severe periodontitis who satisfy the  inclusion and exclusion criteria will be randomised to test and control group. Baseline clinical parameters will be compared with post treatment periodontal parameters 6months after the therapy. Conclusions will be drawn based on results. The aim of this interventional clinical trial is to assess the clinical effectiveness of i-PRF in improving healing outcomes in horizontal defects by comparing it with conventional open flap debridement. This study is such an attempt whereby an inexpensive material which do not cause any allergic reaction can be used for treatment of horizontal bone defects. 
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