NCT07523802

Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Free gingival graft (FGG) harvesting is a commonly used periodontal procedure, but it is associated with significant postoperative pain and discomfort at the palatal donor site. Traditional management using acrylic palatal stents provides mechanical protection but may interfere with patient comfort and oral function. Ora-Aid is a bio-adhesive hydrogel-based wound dressing designed for intraoral use, providing protection, reducing mechanical irritation, and potentially enhancing healing. Despite promising results in previous studies, there is limited evidence from randomized controlled trials comparing Ora-Aid with conventional palatal stents. This study is a randomized, parallel-group clinical trial designed to compare the effectiveness of Ora-Aid and acrylic palatal stents in managing postoperative pain following FGG harvesting. Patients will be randomly allocated in a 1:1 ratio to either intervention group. Pain will be assessed using the Visual Analogue Scale (VAS), while secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match at multiple postoperative time points (3, 7, 14, 21, and 42 days).

Conditions

• Postoperative Pain
• Mucogingival Defects
• Gingival Recessions

Interventions

Type	Name	Description
OTHER	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.
DEVICE	Acrylic Resin Palatal Stent	A custom-made acrylic resin palatal stent is fabricated from an alginate impression and applied to the palatal donor site immediately after free gingival graft harvesting. The stent provides mechanical protection, stabilizes the blood clot, and reduces postoperative trauma. It is retained in place for approximately 2 weeks, with periodic removal for clinical evaluation of wound healing.

Timeline

• Start date: 2026-01-14
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-04-13
• Last updated: 2026-04-14

Locations

1 site across 1 country: Egypt