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CTRI Number  CTRI/2020/08/027233 [Registered on: 19/08/2020] Trial Registered Prospectively
Last Modified On: 14/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   early palatal wound healing using platelet rich fibrin bandage and topically applied hyaluronic acid: A randomised controlled clinical trial. 
Scientific Title of Study   Evaluation of early palatal wound healing using platelet rich fibrin bandage and topically applied hyaluronic acid after free gingival graft harvesting: A randomised controlled clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devapratim Mohanty 
Designation  Assistant Professor 
Affiliation  SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK 
Address  SBC DENTAL COLLEGE, DEPARTMENT OF PERIODONTOLOGY, 3 RD FLOOR,MANGLABAG, CUTTACK, ODISHA. 753007

Cuttack
ORISSA
753012
India 
Phone  09338013446  
Fax    
Email  devapratimm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Devapratim Mohanty 
Designation  Assistant Professor 
Affiliation  SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK 
Address  SBC DENTAL COLLEGE, DEPARTMENT OF PERIODONTOLOGY, 3 RD FLOOR,MANGLABAG, CUTTACK, ODISHA. 753007

Cuttack
ORISSA
753012
India 
Phone  09338013446  
Fax    
Email  devapratimm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Devapratim Mohanty 
Designation  Assistant Professor 
Affiliation  SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK 
Address  SBC DENTAL COLLEGE, DEPARTMENT OF PERIODONTOLOGY, 3 RD FLOOR,MANGLABAG, CUTTACK, ODISHA. 753007

Cuttack
ORISSA
753012
India 
Phone  09338013446  
Fax    
Email  devapratimm@gmail.com  
 
Source of Monetary or Material Support  
department of periodontology 3rd floor, SCB dental college and hospital Cuttack Odisha 
Dr. Devapratim Mohanty  
 
Primary Sponsor  
Name  self DR DEVAPRATIM MOHANTY 
Address  DR DEVAPRATIM MOHANTY SCB DENTAL COLLEGE, DEPARTMENT OF PERIODONTOLOGY, 3 RD FLOOR,MANGLABAG, CUTTACK, ODISHA. 753007 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
self DR DEVAPRATIM MOHANTY  DR DEVAPRATIM MOHANTY SCB DENTAL COLLEGE, DEPARTMENT OF PERIODONTOLOGY, 3 RD FLOOR,MANGLABAG, CUTTACK, ODISHA. 753007 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DEVAPRATIM MOHANTY  SCB DENTAL COLLEGE AND HOSPITAL   DEPARTMENT OF PERIODONTICS 3RD FLOOR
Cuttack
ORISSA 
09338013446

devapratimm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE(IEC)SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA  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  hyaluronic acid gel  hyaluronic acid gel applied to the site after harvesting free gingival graft. 
Intervention  platelet rich fibrin bandage   platelet rich fibrin bandage applied after harvesting free gingival graft from the palate 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cases being treated by free gingival graft.
 
 
ExclusionCriteria 
Details  -Pregnant patients.
-Patients having systemic diseases that contraindicate surgery.
-Patients under medication that modify healing and inflammatory responses.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
early palatal wound healing   3-7 days 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative pain and discomfort assessment and degree of epithelialization   3-21 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   22/08/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction

 Free gingival grafting (FGG) is one of the most common techniques used to increase the dimensions of keratinized tissue (KT).The palatal mucosa in the molar- premolar region is the recommended site for procurement of the graft. However, the donor site heals by secondary intention or “granulating in” and takes about two to four weeks depending on the width and thickness of the tissue harvested.

Platelet rich fibrin (PRF) was first developed in France by Choukroun et al in 2001. PRF is a three-dimensional fibrin network that accelerates wound healing, augments immunity and effective neovascularization. It supports the three crucial steps of wound healing: ‘angiogenesis,’ ‘immunity’ and ‘epithelial proliferation.
            Hyaluronic acid (HA) is a naturally occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid and other tissues  and have a
nti-inflammatory, anti-oedematous and anti-bacterial property. Hyaluronan induces the production of proinflammatory cytokines by fibroblasts, keratinocytes, cementoblasts and osteoblasts which promote the inflammatory response and consequently stimulate hyaluronan synthesis by endothelial cells and result in formation of granulation tissue and the re-establishment of the epithelium.

 

Objective of study

1.      Compare the effectiveness of a platelet rich fibrin bandage and 0.8% Hyaluronic acid bio-adhesive material on the early wound healing at palatal donor sites after harvesting free gingival grafts.  

2.       Evaluate the postoperative pain and discomfort after FGG harvesting in the same groups.

 

 

Review of literature

 

  1. S Yıldırım  Ö Özener (2018)  stated  that Topical application of HA exhibits positive impact on postoperative pain and burning sensation, and accelerates palatal wound healing in terms of epithelization and color match.

 

  1. M ozcan (2017) concluded that Use of platelet rich fibrin at palatal donor site after  FGG harvesting may provide significant benefits in terms of wound healing.

 

 

Methodology

 

Thirty patients requiring FGG (free gingival graft) surgery are randomly assigned into three groups in an examiner‐masked, randomized, controlled clinical trial. After harvesting palatal grafts, 0.8% HA gels and PRF are used in groups 1, 2 respectively (test groups)and protected with periodontal dressing, whereas the wound is covered only with periodontal dressing in the group 3  (control group). The healing and epithelization are evaluated visually by 3% hydrogen peroxide test at days 3, 7, 14, 21.  Landry, Turnbull,and Howley Healing index will be used to assess the healing at the donor site.

Pain will be measured using a visual analogue scale on 3, 7, 14, and 21days. Post operative pain will be indirectly evaluated on the basis of the mean consumption of number of analgesics (paracetamol+acelofenac) in the healing period.

Patient’s post operative discomfort, bleeding and inability to chew will be evaluated with a questionnaire given to patient 1 week following surgery.

 

Potential risks and benefits

Platelet-rich fibrin (PRF), an autologous blood product, is used to deliver growth factors in high concentration that promotes wound healing, bone growth, maturation, graft stabilization, and haemostasis, use of a PRF membrane is effective in accelerating soft-tissue healing. Topical application of HA exhibits positive impact on postoperative pain and burning sensation, and accelerates palatal wound healing in terms of epithelization and colour match.

 

 

 


 
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