Palatal Wound HealingOXYHA-FGGNCT07683351
Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft
A study testing Hyaluronic Acid gel, Active oxygen gel and Gelatin sponge with flowable composite in people with Palatal Wound Healing and Mucogingival Defects, run by Suez Canal University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Palatal Wound Healing, Mucogingival Defects, Free Gingival Graft Donor Site
- What is being tested?
- Hyaluronic Acid gel, Active oxygen gel and Gelatin sponge with flowable composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (>3 mm) Cooperative and motivated patients Good oral hygiene compliance
Who cannot join
- Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate
Shimaa Nasser, +201117286714, pgs.230036@dent.suez.edu.eg
Shimaa Morsy, +20 12 2552703
About this study
Official title: Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting.
Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite.
Read more
Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively.
The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.
Read the detailed description
This study is a randomized controlled clinical trial designed to evaluate the effect of different palatal dressing materials on wound healing following free gingival graft harvesting.
The study will be conducted at the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University, after approval of the Research Ethics Committee and Faculty Council. Thirty systemically healthy patients diagnosed with mucogingival defects requiring free gingival graft procedures will be recruited according to predefined inclusion and exclusion criteria. All participants will sign an informed consent form prior to enrollment.
Patients will be randomly allocated into three equal groups (n = 10 per group) using a computer-generated randomization method. Group A (control group) will receive a gelatin sponge covered with flowable composite on the palatal donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel (Blue®m) covered with a gelatin sponge and flowable composite.
Free gingival grafts will be harvested using the classical Sullivan and Atkins technique. The grafts will be adapted and sutured at the recipient site using resorbable sutures. At the donor site, hemostasis will be achieved using pressure with adrenaline-soaked gauze, followed by application of the assigned dressing protocol for each group.
Postoperative care will include analgesics (Ibuprofen 600 mg as needed), chlorhexidine mouth rinse (0.12%) twice daily for two weeks, and standard postoperative instructions. Patients will be recalled after 1 week for evaluation and removal/reapplication of the dressing when indicated, and again at 2 and 4 weeks for follow-up assessments.
Outcome measures include postoperative pain assessed using a visual analog scale (VAS), total analgesic consumption, wound healing evaluated by Landry healing index, complete wound re-epithelialization assessed using hydrogen peroxide test, two-dimensional wound measurements, and recording of any postoperative complications.
Statistical analysis will be performed using appropriate tests including ANOVA or Kruskal-Wallis test for comparison among groups, and repeated measures analysis for longitudinal data. A p-value ≤ 0.05 will be considered statistically significant.
- Being tested
- Hyaluronic Acid gel, Active oxygen gel, Gelatin sponge with flowable composite
- Keywords
- free gingival graft, palatal wound healing, hyaluronic acid gel, active oxygen gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid gelDrug
Hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
Active oxygen gelDrug
Active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
Gelatin sponge with flowable compositeProcedure or surgery
Gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Participants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management. Receives: Procedure: Gelatin sponge with flowable composite |
| Hyaluronic acid group | Experimental | Participants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting. Receives: Drug: Hyaluronic Acid gel |
| Active oxygen group (Blue®m) | Experimental | Participants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting. Receives: Drug: Active oxygen gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing (Landry Healing Index)
Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing. The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.
Measured: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Secondary outcomes (3)
Postoperative pain (VAS score)
Evaluation of postoperative pain using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain, after free gingival graft harvesting in the three study groups.
Measured: Daily for the first postoperative week (Day 1 to Day 7)
Complete epithelialization (Hydrogen peroxide test)
Assessment of complete wound epithelialization using hydrogen peroxide bubbling test.
Measured: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Two-dimensional wound area reduction
Measurement of the palatal wound surface area (length × width) to assess two-dimensional reduction in wound size over time after free gingival graft harvesting.
Measured: Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start27 Aug 2025
- Primary completion27 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Wound HealingStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Model description
- Participants will be randomly assigned into three parallel groups receiving different palatal dressing materials after free gingival graft harvesting
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683351
- Sponsor's protocol ID
- 919/2024
- Other IDs
- suez canal university
- Acronym
- OXYHA-FGG
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07683351
- Acronym / sponsor ID
- OXYHA-FGG / 919/2024
- Keywords
- free gingival graft, palatal wound healing, hyaluronic acid gel, active oxygen gel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Jul 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.
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting.
Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite.
Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively.
The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.
Detailed description
This study is a randomized controlled clinical trial designed to evaluate the effect of different palatal dressing materials on wound healing following free gingival graft harvesting.
The study will be conducted at the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University, after approval of the Research Ethics Committee and Faculty Council. Thirty systemically healthy patients diagnosed with mucogingival defects requiring free gingival graft procedures will be recruited according to predefined inclusion and exclusion criteria. All participants will sign an informed consent form prior to enrollment.
Patients will be randomly allocated into three equal groups (n = 10 per group) using a computer-generated randomization method. Group A (control group) will receive a gelatin sponge covered with flowable composite on the palatal donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel (Blue®m) covered with a gelatin sponge and flowable composite.
Free gingival grafts will be harvested using the classical Sullivan and Atkins technique. The grafts will be adapted and sutured at the recipient site using resorbable sutures. At the donor site, hemostasis will be achieved using pressure with adrenaline-soaked gauze, followed by application of the assigned dressing protocol for each group.
Postoperative care will include analgesics (Ibuprofen 600 mg as needed), chlorhexidine mouth rinse (0.12%) twice daily for two weeks, and standard postoperative instructions. Patients will be recalled after 1 week for evaluation and removal/reapplication of the dressing when indicated, and again at 2 and 4 weeks for follow-up assessments.
Outcome measures include postoperative pain assessed using a visual analog scale (VAS), total analgesic consumption, wound healing evaluated by Landry healing index, complete wound re-epithelialization assessed using hydrogen peroxide test, two-dimensional wound measurements, and recording of any postoperative complications.
Statistical analysis will be performed using appropriate tests including ANOVA or Kruskal-Wallis test for comparison among groups, and repeated measures analysis for longitudinal data. A p-value ≤ 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned into three parallel groups receiving different palatal dressing materials after free gingival graft harvesting
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: Gelatin sponge with flowable compositeParticipants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management. |
| Hyaluronic acid group | Experimental | Drug: Hyaluronic Acid gelParticipants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting. |
| Active oxygen group (Blue®m) | Experimental | Drug: Active oxygen gelParticipants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (>3 mm) Cooperative and motivated patients Good oral hygiene compliance
Key exclusion criteria (1 listed)
- Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection
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 |
|---|---|---|
| Hyaluronic Acid gelHyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing. | Drug | Hyaluronic acid group |
| Active oxygen gelActive oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing. | Drug | Active oxygen group (Blue®m) |
| Gelatin sponge with flowable compositeGelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management | Procedure or surgery | Control group |
Primary outcome
Wound healing (Landry Healing Index)
Time frame: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing. The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.
3 secondary outcomes
Postoperative pain (VAS score)
Time frame: Daily for the first postoperative week (Day 1 to Day 7)
Complete epithelialization (Hydrogen peroxide test)
Time frame: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Two-dimensional wound area reduction
Time frame: Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Related trials for Palatal Wound Healing
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Recruiting
Dynamics of Wound Healing in Patients With Obesity
Wound Healing
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid gel, Active oxygen gel and Gelatin sponge with flowable composite in people with Palatal Wound Healing and Mucogingival Defects, run by Suez Canal 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (Landry Healing Index) (time frame: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively). 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 22 Jul 2026.