RecruitingNot ApplicableNCT07523802

Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent: A Randomized Clinical Trial

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.


Sponsor

Cairo University

Enrollment

20 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Patient over 18 years of age
  • Systemically healthy
  • Patients with good oral hygiene
  • Patients with mucogingival defects scheduled for free gingival graft (FGG)

Exclusion Criteria4

  • Pregnancy or breastfeeding
  • Severe gagging reflex
  • Smokers
  • Patients allergic to the materials used in the study

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Interventions

OTHEROra-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.

DEVICEAcrylic 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.


Locations(1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

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NCT07523802


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