Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
- Conditions
- Inadequately Attached Gingiva (Disorder)
- Interventions
- Drug: ozonated oil
- Registration Number
- NCT04828720
- Lead Sponsor
- Cairo University
- Brief Summary
This randomized clinical trial was conducted to assess the effects of platelets-rich fibrin (PRF) and ozonated oil on the healing of palatal donor wound sites and the patient's morbidity after free gingival graft (FGG) harvesting
- Detailed Description
Many surgical techniques have been suggested to enhance the width of keratinized tissue either by free gingival grafts (FGGs) or by sub-epithelial connective tissue grafts. FGG is easy to carry out and qualify the harvest of large quantities of connective tissues (CT). Contrariwise, it produces a site of secondary intention wound healing with discomfort and pain. Excessive post-operative morbidity has been reported in the literature as a possible complication of harvesting a FGG; different procedures with primary-intention healing have been proposed to overcome this problem.
The use of a platelet-rich fibrin (PRF) membrane to coat the fresh wound may accelerate the process of healing by providing a more stable rigid fibrin mesh, which is better than a blood clot and supplying a sustained release of growth factors promoting rapid hemostasis at the FGG donor site. PRF is a platelet concentrate obtained by inexpensive and simple procedure that does not need biochemical blood handling, it promotes efficient neovascularization, hastened wound closure and rapid cicatricial tissue remodeling through its three-dimensional fibrin meshwork. PRF owing its energizing effect on wound healing as it provides a superb scaffold for epithelialization and angiogenesis together with the presence of many growth factors such as platelet-derived growth factor (PDGF), epidermal growth factor and fibroblast growth factor (FGF).
Presently, most of researches in dental field using either ozone gas only, dissolved in water (ozonated water) or in plant oils such as olive oil (ozonated oil), focusing on its excellent antimicrobial efficacy, enhancement of wound healing in oral cavity without the possibility of drug resistance.
Oral wound healing is a dynamic process and complex phenomenon involving series overlapping stages of restoring tissue and cellular structures. Cellular and biochemical events in wound healing can be divided into several phases: inflammation, granulation tissue formation, matrix formation, re-epithelialization and tissue remodeling. Epithelial healing or re-epithelialization is an important process that involves the interactions between keratinocytes and extracellular matrix upon which cells migrate, proliferate and differentiate, hence restoring tissue function and structure. The rate of re-epithelization is considered as one of the criteria that reflect the influence of PRF and ozonated oil on healing of wound sites.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- (a) age ≥18 years and (b) healthy individuals without any systemic condition that might affect directly on the inflammatory status.
- (1) patients with coagulation disorders, (2) severe psychiatric disorders, (3) heavy smokers, (4) patients wearing complete or partial denture that had any contact with the palate, (5) lactating or pregnant females and (6) no FGG harvested previously from the site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRF group ozonated oil The PRF was prepared according to Choukroun et al. \[5\] immediately before surgery, a 10 ml blood sample was taken by venipuncture of the antecubital vein without anticoagulant. The tubes were centrifuged immediately by a dedicated centrifuge at 3,000 rpm for 10 minutes. A structured fibrin clot was produced by such preparation protocol in the middle of the tube, with the erythrocytes at the bottom and acellular plasma at the top. Following elimination of acellular plasma, a sterile scissors was used to separate the PRF from the erythrocytes. A membrane of PRF was formed by squeezing it gently between two pieces of gauze. Folding of the membrane was performed to achieve the required thickness (1.0 mm) with accurate trimming to match the palatal wound. The obtained membrane was then placed at the palatal donor site and compressed with gauze. Then, it was secured with 3-0 black plaited silk and a stent was placed. ozonated group ozonated oil the palatal wound in ozanaited group will be painted by ozainated oil 2ml daily for 1 week, Patients used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued. Control group ozonated oil the palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in control group used a soft stent to protect the palatal donor wound site . Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued.
- Primary Outcome Measures
Name Time Method the Healing assessed weekly for 1 month The healing assesed by healing index
1- very poor. 5- excellent
- Secondary Outcome Measures
Name Time Method cytological analysis after 7, 14, 21 days and 2 months assess the re-epithelization and keratinization rate
The Pain after 24 hours and 1 week assessed by visual analogue scale (VAS)
Trial Locations
- Locations (1)
October 6 University
🇪🇬Giza, Egypt