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CTRI Number  CTRI/2022/04/042092 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of platelet concentrate in non surgical treatment of periodontitis 
Scientific Title of Study   Evaluation of the effectiveness of adjunctive intra pocket delivery of injectable platelet concentrate (iPRF) in non surgical periodontal therapy-A randomized controlled split mouth 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 Baiju R M 
Designation  Additional professor 
Affiliation  Government Dental College 
Address  Department Of Periodontics Government Dental College Gandhinagar P O Kottayam

Kottayam
KERALA
686008
India 
Phone  9447279605  
Fax    
Email  baijurm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Baiju R M 
Designation  Additional professor 
Affiliation  Government Dental College 
Address  Department Of Periodontics Government Dental College Gandhinagar P O Kottayam

Kottayam
KERALA
686008
India 
Phone  9447279605  
Fax    
Email  baijurm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Baiju R M 
Designation  Additional professor 
Affiliation  Government Dental College 
Address  Department Of Periodontics Government Dental College Gandhinagar P O Kottayam

Kottayam
KERALA
686008
India 
Phone  9447279605  
Fax    
Email  baijurm@gmail.com  
 
Source of Monetary or Material Support  
State Board Of Medical Reasearch 
 
Primary Sponsor  
Name  State Board Of Medical Research 
Address  Government Medical College Kottayam 
Type of Sponsor  Government medical college 
 
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 Baiju R M  Government Dental College Kottayam  Department Of Periodontics Room no:801 Gandhinagar PO Kottayam Pin:686008
Kottayam
KERALA 		 9447279605

baijurm@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 intra pocket delivery of iPRF in non surgical periodontal therapy in patients with moderate to severe periodontitis  In addition to the procedures undertaken for control group ,test group will receive adjunctive intra pocket delivery of iPRF once after non surgical periodontal therapy followed by evaluation at baseline,3rd month and 6th month. 
Comparator Agent  Standard non surgical therapy(scaling and root planing)  The control group will receive standard non surgical periodontal therapy under local anesthesia in not more than two sittings within a span of 48hrs followed by 0.9 % normal saline irrigation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  (a) subjects with age more than 18
(b) systemically healthy subjects
(c) Patients with at least two sites with probing pocket depth (PPD) ≥ 5 mm on contralateral side either in maxilla or mandible
 
 
ExclusionCriteria 
Details  1) Subjects with habit of Smoking and tobacco chewing
3) Subjects taking Medications affecting the periodontium
4) Pregnancy or lactation
5) Subjects received probiotic or antimicrobial therapy in the past 6 months
6) Subjects underwent periodontal therapy in the past 6 months
 
 
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 
Probing pocket depth  Final outcome assessed at 6th month after nonsurgical periodontal therapy 
 
Secondary Outcome  
Outcome  TimePoints 
1) clinical attatchment level
2) Gingival recession 		 Final outcome assessed at 6th month after nonsurgical periodontal therapy 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) 19/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/12/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 manuscript prepared and sent for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Periodontal disease is the sixth most prevalent health condition that affects humans. It is one of the important reasons for tooth loss, impacts the quality of life of individuals. Emerging evidence links it to several systemic life threatening conditions like cardiovascular disease and diabetes making it an important public health problem. The objective of the prospective intervention trial is to assess the effectiveness of intrapocket delivery of injectable platelet rich fibrin in the non surgical management of moderate to severe periodontitis when compared to conventional scaling root planing. These autologous platelet concentrate are suspensions of growth factors and when applied locally ,they can induce soft and hard tissue regeneration. Since the standard PRF is not entirely appropriate for injection ,a new injectable formulation of PRF(termed i-PRF)enables easier use of platelet concentrate in liquid state. Otherwise healthy adults with moderate to severe periodontitis who satisfies the inclusion criteria are included in the study.Eligible individuals are randomized into test and control groups by split mouth design. Conclusions will be drawn based on the results. Treatment of periodontal disease is complicated and expensive. Many patients require invasive procedures including regenerative therapy. Adjunctive approaches to conventional non surgical therapy has page  been investigated widely to avoid invasive surgical interventions. This study is such an attempt, where by an  adjuvant like autologous platelet concentrate is added to conventional nonsurgical therapy in order to assess whether there is any improvement in clinical outcomes when compared to non surgical therapy alone. although PPD reduction is considered as the primary outcome, pocket closure would be considered as a clinically relevant outcome. If found beneficial it would be highly encouraging for the resource poor Indian health system. 
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