Assessment of Platelet-Rich Fibrin and Topical Ozonated Oil in the Management of Palatal Wound Healing After Free Gingival Graft Harvest

Inadequately Attached Gingiva (Disorder) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828720
• Other study ID #: 0000034
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inadequately Attached Gingiva (Disorder)

Intervention

Drug:
• ozonated oil
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.

Locations

Country	Name	City	State
Egypt	October 6 University	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Healing	The healing assesed by healing index; 1- very poor. 5- excellent	assessed weekly for 1 month
Secondary	The Pain	assessed by visual analogue scale (VAS)	after 24 hours and 1 week
Secondary	cytological analysis	assess the re-epithelization and keratinization rate	after 7, 14, 21 days and 2 months