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Effectiveness of Ora-Aid Oral Wound Dressing Compared to Acrylic Palatal Stent in Managing Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial
Led by Cairo University · Updated on 2026-04-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to compare two methods for managing pain after free gingival graft (FGG) harvesting, a common dental procedure that can cause significant discomfort at the palatal donor site. The study evaluates the effectiveness of Ora-Aid, a hydrogel-based oral wound dressing, against a traditional acrylic palatal stent. The trial is randomized and single-blind, focusing on postoperative pain and other healing measures over several weeks. Participants will be randomly assigned to one of two groups: one group will receive a custom-made acrylic resin palatal stent, which covers the donor site and is retained for about two weeks with periodic removal for wound checks. The other group will receive the Ora-Aid dressing applied directly to the wound, fixed with sutures, and reapplied every 3 to 5 days as needed until healing is complete, typically within 10 to 14 days. During the study, participants will be monitored for pain levels daily for the first week using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic use, wound size measurements, patient satisfaction at one week, and color matching of the palatal mucosa over 42 days. Follow-up visits will assess healing progress and comfort, with the total observation period lasting six weeks after surgery.
CONDITIONS
Brief Title
Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years of age
- Systemically healthy
- Patients with good oral hygiene
- Patients with mucogingival defects scheduled for free gingival graft (FGG)
You will not qualify if you...
- Pregnancy or breastfeeding
- Severe gagging reflex
- Smokers
- Patients allergic to the materials used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 2 weeks or until wound healing is complete
Participants receive either the Ora-Aid oral wound dressing or an acrylic resin palatal stent immediately after free gingival graft harvesting to manage postoperative pain and protect the palatal donor site.
Multiple visits for wound evaluation and dressing or stent management over 2 weeks, including visits at Day 3, 7, 14, 21, and 42 for assessments
Duration - Up to 6 weeks post-surgery
Participants are monitored for postoperative pain, analgesic use, wound healing, patient satisfaction, and color match of the palatal mucosa after treatment ends.
Visits on Days 21 and 42 for wound and healing assessments
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Cairo University
Cairo, Egypt, 12613
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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