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
|
|
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 anti-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 - 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.
- 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 examinerâ€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. |