Ozonated Gel and Titanium Platelet-rich Fibrin (on Palatal Wound Healing

Comparison of Topically Applied Ozonated Gel and Titanium Platelet-rich Fibrin (Tprf) on Palatal Wound Healing (A Randomized Controlled Clinical Trial)

Background: autogenous soft tissue grafts can be considered the gold standard for treatment of mucogingival problems. The most common site for harvesting the graft is the palate. The palatal donor site for free gingival graft (FGG) significantly influences the pain and discomfort experienced by the patient, and there is a potential for postoperative bleeding.To overcome these problems many dressing materials associated with topical formulae have been used.

Aim: The objective of this study is to assess the effect of topically applied ozonated oil on palatal wound healing and compare it to the effect of titanium platelet rich fibrin (TPRF)

Study Overview

• Status: Completed
• Conditions: Palatal Lesion
• Intervention / Treatment: Other: Ozonated Gel Application; Other: T-PRF Application; Other: Conventional treatment

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Isolated gingival recession defects on the mandibular and maxillary anterior teeth with insufficient keratinized gingiva.
• Good oral hygiene

Exclusion Criteria:

• Patients reporting systemic conditions that may compromise healing or bone metabolism
• Patients having a history of radiotherapy, chemotherapy or bisphosphonate therapy.
• Pregnant women or those planning to get pregnant during the study course
• History of periodontal disease or previous periodontal surgery on the experimental sites
• Smoking or any other deleterious habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ozonated gel	Other: Ozonated Gel Application; After harvesting the free palatal grafts, an adrenaline-soaked sterile surgical gauze was applied to the palatal donor sites with firm pressure for 5 minutes to achieve hemostasis. Subsequently, ozonated gel loaded on gelatin foam was placed over the donor sites and stabilized using flowable composite.
Active Comparator: Application of TPRF	Other: T-PRF Application; Twenty milliliters of venous blood were collected from the antecubital vein and immediately centrifuged at 2800 rpm for 12 minutes. The resulting T-PRF clots were retrieved using sterile tweezers, separated from the red blood cell layer, and placed on sterile woven gauze. The clots were allowed to exude serum for 20 minutes, then gently compressed between gauze to form T-PRF membranes. The membranes were trimmed to fit the FGG donor site and covered with flowable composite.
Other: flowable composite	Other: Conventional treatment; After harvesting the free palatal grafts, an adrenaline-soaked sterile surgical gauze was applied to the palatal wounds with firm pressure for 5 minutes to achieve hemostasis. The palatal wounds were then covered with flowable composite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores	Patients will be asked to grade the severity of pain using VAS. It ranges across a continuum from none to an extreme amount of pain in a straight horizontal 10 cm line [from 0-100 mm].	Up to 14 days
Change in wound area	Standardized clinical photographs of the palatal surgical sites will be obtained on the day of surgery and at 3, 7, 10, and 14 days postoperatively. Photographs will be taken perpendicular to the wound area, with a standard-sized visual scale placed adjacent to the palatal wounds to allow accurate wound size measurement and analysis.	Baseline, 3 days, 7 days, 10 days, and 14 days

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0968_ 09/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No