Clinical trial NCT04828720: Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
Official title: Clinical and Cytological Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inadequately Attached Gingiva (Disorder)
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: October 6 University
First posted: 2021-04-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* (a) age ≥18 years and (b) healthy individuals without any systemic condition that might affect directly on the inflammatory status.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: the Healing
timeFrame: assessed weekly for 1 month
Secondary outcomes:
measure: The Pain
timeFrame: after 24 hours and 1 week
measure: cytological analysis
timeFrame: after 7, 14, 21 days and 2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References: