Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
Condition: Inadequately Attached Gingiva (Disorder)
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): ozonated oil
Intervention type(s): Drug
Intervention description(s): All patients in ozone group were asked to visit the clinic on a daily basis through the first week and have their allocated therapeutic medication applied to their particular palatal donor site wounds. The wounds were coated with 2 ml ozonated oil per day, with a concentration of 15 µg of ozone/ml of olive oil. Moreover, palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in ozone group used a soft stent to protect the palatal donor wound site and to retain the tested oils in the post harvested palatal wounds. 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In patients with inadequate zone of attached gingiva, treatment planned for FGGs to augment keratinized tissue dimensions in the mandibular incisor area.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment