Clinical Effectiveness of Oral Wound Dressing (Ora-Aid) in Comparison to Palatal Stent in Management of Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial.
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Patients undergoing graft harvesting will be randomly assigned to receive either Ora-Aid dressing or a palatal stent at the donor site. The primary outcome is postoperative pain assessed using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match over a 42-day follow-up period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient over 18 years of age
• Systemically healthy
• Patients with good oral hygiene
• Patients with mucogingival defects scheduled for free gingival graft (FGG)
Locations
Other Locations
Egypt
Faculty of Dentistry, Cairo University
RECRUITING
Cairo
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 20
Treatments
Active_comparator: Palatal Stent
Participants in this arm will receive an acrylic resin palatal stent to cover the palatal donor site immediately after free gingival graft harvesting. The stent will be fabricated using alginate impression with two Adams clasps and wax relief between the canine and second molar to accommodate gauze placement. The stent will be retained for two weeks and removed at day 3 for wound evaluation before being replaced.
Experimental: Ora-Aid Oral Wound Dressing
Ora-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical barrier over the wound, preventing mechanical irritation and reducing pain. Reapplication will occur every 3-5 days as needed until complete epithelialization is achieved (typically 10-14 days). The adhesive integrity of Ora-Aid typically lasts up to 72 hours.
Related Therapeutic Areas
Sponsors
Leads: Cairo University