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

NCT ID: NCT07320391

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-30

Brief Summary

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)

Conditions

Palatal Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ozonated gel

Group Type: EXPERIMENTAL

Ozonated Gel Application

Intervention Type: OTHER

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.

Application of TPRF

Group Type: ACTIVE_COMPARATOR

T-PRF Application

Intervention Type: OTHER

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.

flowable composite

Group Type: OTHER

Conventional treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0968_ 09/2024

Identifier Type: -

Identifier Source: org_study_id