Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSuez Canal University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic Acid gel
DrugHyaluronic 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
DrugActive 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 composite
Procedure/SurgeryGelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Hyaluronic acid groupExperimental treatment 1 intervention
Group C: Active oxygen group (Blue®m)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 week, 2 weeks, 3 weeks and 4 weeks postoperativelySecondary outcomes
1
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.
Time frame
Daily for the first postoperative week (Day 1 to Day 7)2
Complete epithelialization (Hydrogen peroxide test)
Assessment of complete wound epithelialization using hydrogen peroxide bubbling test.
Time frame
1 week, 2 weeks, 3 weeks and 4 weeks postoperatively3
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.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov