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

NCT04828720 | Completed Phase 1

• 1 other identifier: 0000034
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Inadequately Attached Gingiva (Disorder)

Outcome Measures

Primary Outcomes (1)

• the Healing

  The healing assesed by healing index 1- very poor. 5- excellent

  assessed weekly for 1 month

Secondary Outcomes (2)

• The Pain

  after 24 hours and 1 week

• cytological analysis

  after 7, 14, 21 days and 2 months

Study Arms (3)

PRF group

ACTIVE COMPARATOR

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.

Drug: ozonated oil

Control group

PLACEBO COMPARATOR

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.

Drug: ozonated oil

ozonated group

EXPERIMENTAL

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.

Drug: ozonated oil

Interventions

ozonated oil DRUG

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.

Control group; PRF group; ozonated group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Cairo University: lead
• October 6 University: collaborator

Study Sites (1)

October 6 University

Giza, 002, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: opaque envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of periodontology

Model Details: In patients with inadequate zone of attached gingiva, treatment planned for FGGs to augment keratinized tissue dimensions in the mandibular incisor area.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 2, 2021
• Study Start: October 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

EG (1)