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CTRI Number  CTRI/2025/08/093827 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Evaluating the Benefits of i-PRF in Gum Disease Treatment for Smokers and Non-Smokers 
Scientific Title of Study   Comparative evaluation of the efficacy of subgingival application of i-PRF as adjunctive therapy to SRP in treatment of smoker versus non-smoker patients with Periodontitis: A split-mouth, randomized controlled clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Singh 
Designation  Postgraduate student 
Affiliation  Sudha Rustagi College of Dental science and research 
Address  Dept of Periodontology and Oral Implantology Sudha Rustagi College of Dental Science and Research Faridabad

Faridabad
HARYANA
121002
India 
Phone  08447926820  
Fax    
Email  nehadrsingh3093@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenu Taneja Bhasin 
Designation  Professor 
Affiliation  Sudha Rustagi College of Dental science and research 
Address  Dept of Periodontology and Oral Implantology Sudha Rustagi College of Dental Science and Research Faridabad

Faridabad
HARYANA
121002
India 
Phone  9871044433  
Fax    
Email  drmeenu2005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Singh 
Designation  Postgraduate student 
Affiliation  Sudha Rustagi College of Dental science and research 
Address  Dept of Periodontology and Oral Implantology Sudha Rustagi College of Dental Science and Research Faridabad

Faridabad
HARYANA
121002
India 
Phone  08447926820  
Fax    
Email  nehadrsingh3093@gmail.com  
 
Source of Monetary or Material Support  
Sudha Rustagi college of dental science and research Faridabad Haryana India 121002 
 
Primary Sponsor  
Name  Dr. Neha Singh 
Address  Dept of Periodontology and Oral Implantology Sudha Rustagi College of Dental Science and Research Faridabad 
Type of Sponsor  Other [Self Funded] 
 
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 Neha Singh  Sudha Rustagi College of Dental science and research  Dept of Periodontology and Oral Implantology Room number 8 Sudha Rustagi College of Dental Science and Research
Faridabad
HARYANA 		 08447926820

nehadrsingh3093@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRCDSR/IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stage II–III, Grade A or B Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injectable Platelet Rich Fibrin (i-PRF)  i-PRF was prepared by centrifuging 10 ml of venous blood at 700 rpm for 3 minutes without anticoagulant.  
Comparator Agent  Placebo  Distilled water 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria included greater than or equal to 20 teeth, greater than or equal to contralateral sites with probing depth 5 to 6 mm and CAL less than or equal to 5 mm, and absence of plaque-retentive factors.  
 
ExclusionCriteria 
Details  Exclusion criteria included systemic disease, recent periodontal therapy or antibiotics, pregnancy or lactation, or need for periodontal surgery. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in probing pocket depth (PPD)
Gain in clinical attachment level (CAL) 
Baseline (prior to intervention)

1 month

3 months

6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in Plaque Index (Silness and Löe, 1964), Gingival Index (Löe and Silness, 1963), and Gingival Bleeding Index (Ainamo & Bay, 1975) in smokers and non-smokers with periodontitis.  Baseline (prior to intervention)

1 month

3 months

6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/09/2025 
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)   Open to Recruitment 
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 - NO
Brief Summary   Periodontitis is a chronic inflammatory disease that can lead to progressive destruction of periodontal tissues. Smoking is a major risk factor that negatively influences the outcome of periodontal therapy. Injectable platelet-rich fibrin (i-PRF), a second-generation platelet concentrate, has shown potential in promoting periodontal healing and regeneration.
This randomized, split-mouth clinical trial aims to compare the efficacy of subgingival application of i-PRF as an adjunctive therapy to scaling and root planing (SRP) in smoker and non-smoker patients with periodontitis. Clinical parameters including probing pocket depth, clinical attachment level, and bleeding on probing will be evaluated as primary outcomes, while plaque index, gingival index, and gingival bleeding index will be assessed as secondary outcomes over a follow-up period of 3 months. 
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