early palatal wound healing using platelet rich fibrin bandage and topically applied hyaluronic acid: A randomised controlled clinical trial.
- Conditions
- Chronic periodontitis,
- Registration Number
- CTRI/2020/08/027233
- Lead Sponsor
- self DR DEVAPRATIM MOHANTY
- 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**
1. ***[S Yıldırım](https://aap.onlinelibrary.wiley.com/action/doSearch?ContribAuthorStored=Y%C4%B1ld%C4%B1r%C4%B1m%2C+Selin)******[Ö Özener](https://aap.onlinelibrary.wiley.com/action/doSearch?ContribAuthorStored=%C3%96zener%2C+Hafize+%C3%96zt%C3%BCrk)******(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.
2. ***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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 90
Cases being treated by free gingival graft.
- Pregnant patients.
- Patients having systemic diseases that contraindicate surgery.
- Patients under medication that modify healing and inflammatory responses.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method early palatal wound healing 3-7 days
- Secondary Outcome Measures
Name Time Method postoperative pain and discomfort assessment and degree of epithelialization 3-21 days
Trial Locations
- Locations (1)
SCB DENTAL COLLEGE AND HOSPITAL
🇮🇳Cuttack, ORISSA, India
SCB DENTAL COLLEGE AND HOSPITAL🇮🇳Cuttack, ORISSA, IndiaDR DEVAPRATIM MOHANTYPrincipal investigator09338013446devapratimm@gmail.com