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CTRI Number  CTRI/2023/05/053103 [Registered on: 24/05/2023] Trial Registered Prospectively
Last Modified On: 24/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of blood processed bandage on wound healing in mouth 
Scientific Title of Study   Effect Of T-PRF Bandage on Pain and Epithelial Wound Healing at Palatal Donor Site: An Examiner-Masked, 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  Satyaki Verma 
Designation  PG Student 
Affiliation  Institute Of Dental Sciences 
Address  Room no 228, Department of Periodontology and Implantology

Bareilly
UTTAR PRADESH
244001
India 
Phone  09897517095  
Fax    
Email  satyakiverma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rika Singh 
Designation  Reader 
Affiliation  Institute Of Dental Sciences 
Address  Department of Periodontology and implantology, Institute Of Dental Sciences, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9458411133  
Fax    
Email  rikasingh22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Satyaki Verma 
Designation  PG Student 
Affiliation  Institute Of Dental Sciences 
Address  Room no 228, Department of Periodontology and Implantology

Bareilly
UTTAR PRADESH
244001
India 
Phone  09897517095  
Fax    
Email  satyakiverma@gmail.com  
 
Source of Monetary or Material Support  
Institute of Dental Sciences, Bareilly 
 
Primary Sponsor  
Name  Satyaki Verma 
Address  Room no 224, Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly 
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 
Satyaki Verma  Institute of Dental Sciences  Room no 224, Department of Periodontology and Implantology
Bareilly
UTTAR PRADESH 
09897517095

satyakiverma@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 
Comparator Agent  lyophilized hydrolyzed collagen sponge  Placement of the lyophilized hydrolyzed collagen sponge over the palatal exposed site resulting from the extraction of Free Gingival Graft and healing that occurs after 21 days 
Intervention  Titanium prepared Platelet Rich Fibrin(TPRF)  Placement of the Titanium prepared Platelet Rich Fibrin(TPRF) over the palatal exposed site resulting from the extraction of Free Gingival Graft and healing that occurs after 21 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age more than 18 years.
Without systemic diseases,
No medical contraindications for periodontal surgery, and
Adequate level of plaque control (plaque index < 15%).
 
 
ExclusionCriteria 
Details  Systemically compromised patients e.g.-uncontrolled diabetes
Patients who are on medications that could interfere with wound healing.
Patients having to use removable partial denture for the upper arch.
Pregnant and lactating females.
Evidence of Malocclusion, or Crowding or any other local factors complicating the overall prognosis of the area.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The aim of this randomized controlled clinical trial is to assess the effect of Titanium prepared, platelet-rich fibrin (T-PRF) membranes on healing and re-epithelization of palatal wounds resulting from free gingival graft (FGG) harvesting.  Baseline,2 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the level of wound healing and epithelization by the use of TPRF on FGG extracted site during wound healing post-surgery in the test group.
To assess the level of wound healing and epithelization on the FGG extracted site during wound healing post-surgery in the control group.
To find out any possible difference between the two and the extent to which the TPRF influences the wound healing, epithelization and patient related outcomes.
 
Baseline,2 Months 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
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 2 
Date of First Enrollment (India)   08/06/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Free gingival graft (FGG) is a successful treatment for deficiency of keratinized soft tissue surrounding teeth and implants. In the conventional FGG procedure, the keratinized gingiva consisting of epithelium and a thin layer of underlying connective tissue from the donor site is transferred to the recipient site. It is suggested that 2 mm of keratinized tissue is adequate to maintain gingival and peri-implanter health. The keratinized gingiva surrounding the teeth and implants increases the resistance of the tissues to shrinkage and provides stability during prosthetic procedures. In cases where there is insufficient attached gingiva/peri-implant keratinized mucosa, it is necessary to increase the amount of attached soft tissue by using mucogingival surgical methods such as FGG procedures.7-11

A platelet-rich fibrin clot (PRF) is preferred for the stabilization and revascularization of hard and soft tissue grafts due to their growth factors and plays a decisive role in haemostasis with its coagulating factors. From the moment it is applied to the area, it turns into a kind of biological adhesive shield that can consolidate the first set of platelets, thereby creating a vascularized protective wall to decrease the risk of contamination by microorganisms. The acceleration of vascularization due to growth factors, absence of toxic or allergic reactions due to autogenous graft, being economical and biocompatible are some of the advantages of applying PRF to the donor site. In recent years, titanium-prepared PRF (T-PRF) which is based on the hypothesis that titanium tubes may be more effective activating platelets than the glass tubes are used as an alternative for PRF. It has been stated that the contact of PRF and the silica is inevitable due to the preparation in a glass tube which makes the affiliation weaker in conventional PRF. Besides, the activation of platelets with titanium compared with activation with silica particles might provide increased biocompatibility due to possible adverse effects of silica particles. Several studies revealed that T-PRF has a longer resorption time than conventional PRF.12

Therefore, this study aimed to assess the healing effect of T-PRF clot membranes in palatal wounds after FGG harvesting and to compare the postsurgical pain experience and complications with a conventional procedure where a gelatine sponge was placed in the palatal wound.

 
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