Palatal LesionNCT07320391
Ozonated Gel and Titanium Platelet-rich Fibrin (on Palatal Wound Healing
A study testing Ozonated Gel Application, T-PRF Application and Conventional treatment in people with Palatal Lesion, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Palatal Lesion
- What is being tested?
- Ozonated Gel Application, T-PRF Application and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Isolated gingival recession defects on the mandibular and maxillary anterior teeth with insufficient keratinized gingiva.
- Good oral hygiene
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: 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)
- Conditions
- Palatal Lesion
- Being tested
- Ozonated Gel Application, T-PRF Application, Conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated Gel ApplicationOther
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.
T-PRF ApplicationOther
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.
Conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ozonated gel | Experimental | Not described Receives: Other: Ozonated Gel Application |
| Application of TPRF | Active comparator | Not described Receives: Other: T-PRF Application |
| flowable composite | Other | Not described Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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.
Measured: Baseline, 3 days, 7 days, 10 days, and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal LesionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320391
- Sponsor's protocol ID
- 0968_ 09/2024
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topically Applied Ozonated Gel and Titanium Platelet-rich Fibrin (Tprf) on Palatal Wound Healing (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07320391
- Acronym / sponsor ID
- 0968_ 09/2024
- Conditions
- Palatal Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ozonated gel | Experimental | Other: Ozonated Gel Application |
| Application of TPRF | Active comparator | Other: T-PRF Application |
| flowable composite | Other | Other: Conventional treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Isolated gingival recession defects on the mandibular and maxillary anterior teeth with insufficient keratinized gingiva.
- Good oral hygiene
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozonated Gel ApplicationAfter 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. | Other | ozonated gel |
| T-PRF ApplicationTwenty 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 | Application of TPRF |
| Conventional treatmentAfter 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. | Other | flowable composite |
Primary outcome
Change in pain scores
Time frame: Up to 14 days
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].
Change in wound area
Time frame: Baseline, 3 days, 7 days, 10 days, and 14 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Related trials for Palatal Lesion
Not yet recruiting
Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery
Adenoid Hypertrophy, Tonsillar Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated Gel Application, T-PRF Application and Conventional treatment in people with Palatal Lesion, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: Up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.