Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07683351
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Ismailia, Ismailia Governorate, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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 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 covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management
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.
Time frame: Daily for the first postoperative week (Day 1 to Day 7)
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.
Time frame: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Assessment of complete wound epithelialization using hydrogen peroxide bubbling test.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
Measurement of the palatal wound surface area (length × width) to assess two-dimensional reduction in wound size over time after free gingival graft harvesting.
Suez Canal University
Other
Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
Acronym: OXYHA-FGG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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