FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103886 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare three additional treatments (platelet concentrate injection, laser therapy, and hyaluronic acid gel) to improve healing and gum health in patients with chronic gum disease. 
Scientific Title of Study   Comparative evaluation of the adjunctive effect of injectable platelet rich fibrin (i-PRF), 970 nm diode laser and hyaluronic acid on post operative healing and clinical parameters for the treatment of chronic periodontitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PERIO/01/232471/IEC  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Pandey 
Designation  MDS student 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department Number 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareli Road, Utrathia, Chaudhary Vihar

Lucknow
UTTAR PRADESH
226029
India 
Phone  9319015379  
Fax    
Email  dr.aditi.perio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Srivastava 
Designation  Professor 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department Number 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareli Road, Utrathia, Chaudhary Vihar

Lucknow
UTTAR PRADESH
226029
India 
Phone  9936859555  
Fax    
Email  drviveksrivastav89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Srivastava 
Designation  Professor 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department Number 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareli Road, Utrathia, Chaudhary Vihar

Lucknow
UTTAR PRADESH
226029
India 
Phone  9936859555  
Fax    
Email  drviveksrivastav89@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Aditi Pandey 
Address  23 B, Skylark Apartments, DDA, SFS Flats, Site II, Ghazipur, Delhi - 110096. 
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 Aditi Pandey  Sardar Patel Post Graduate Institute of Dental and Medical Sciences  Department Number 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareli Road, Utrathia, Chaudhary Vihar
Lucknow
UTTAR PRADESH 		 9319015379

dr.aditi.perio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CHRONIC PERIODONTITIS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diode laser and OFD  970 nm diode laser used as an adjunct to OFD 
Comparator Agent  Hyaluronic acid and OFD  0.8 percent hyaluronic acid used as an adjunct with OFD 
Comparator Agent  i-PRF and OFD  Injectable Platelet Rich Fibrin (platelet concentrate) made from patients own venous blood used as an adjunct to OFD 
Intervention  OFD  Open Flap Debridement 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Medically healthy patients. Patient who have persistent PPD equal to or more than 5 mm and CAL equal to or more than 4 mm. Patients who want to participate in the study. Patients who are capable of maintaining proper dental hygiene.
 
 
ExclusionCriteria 
Details  Patients who have uncontrolled systemic diseases. Patients who had flap surgery during the last six months. Patients who require extensive osseous manipulation. Patients who are on antibiotic and long term steroids. Tobacco chewers and smokers. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level.  Baseline and 1 month & 3 months post-surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain.  24 hours, 3rd day and 7th day post-surgery. 
Post operative healing.   24 hours, 3rd day and 7th day post-surgery. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   01/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
    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 - Any purpose.

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

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The present clinical trial describes a split-mouth design to evaluate the the possible clinical effects and regenerative potential of three different adjunctive agents as compared to open flap debridement for surgical periodontal therapy. A total of 10 patients ( 40 quadrants) who fulfilled the inclusion criteria were taken into the study and were randomly divided into 4 groups. 
Close