Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronic Acid gel, Active oxygen gel, Gelatin sponge with flowable composite.
- Who it may be relevant to
- Registry conditions: Palatal Wound Healing, Mucogingival Defects, Free Gingival Graft Donor Site. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Drug Hyaluronic Acid gel
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. - Drug Active oxygen gel
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. - Procedure Gelatin sponge with flowable composite
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
Primary outcome measures
- Wound healing (Landry Healing Index) [Time frame: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Suez Canal University — Ismailia
Identifiers
NCT: NCT07683351 · 919/2024 · suez canal university