Managing pain after free gingival graft harvesting with Ora-Aid versus an 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.
This trial will test whether an Ora-Aid hydrogel dressing or an acrylic palatal stent better reduces pain for adults after free gingival graft donor-site harvesting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07523802 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-group clinical trial at the Faculty of Dentistry, Cairo University, that assigns adults undergoing free gingival graft (FGG) harvesting 1:1 to receive either an Ora-Aid bio-adhesive hydrogel dressing or an acrylic resin palatal stent at the palatal donor site. The primary outcome is postoperative pain measured by the Visual Analogue Scale (VAS) at multiple time points, with secondary outcomes including analgesic use, wound size, patient satisfaction, and color match assessed over 42 days. Participants are systemically healthy adults with good oral hygiene and mucogingival defects scheduled for FGG; smokers, pregnant or breastfeeding patients, those with severe gag reflex, or allergies to study materials are excluded.
Who should consider this trial
Good fit: Adults in good general health with mucogingival defects who are scheduled for free gingival graft harvesting, have good oral hygiene, and are non-smokers would be ideal candidates.
Not a fit: Smokers, pregnant or breastfeeding patients, people with a severe gag reflex, or those allergic to the materials used would not be eligible and are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the Ora-Aid dressing could reduce postoperative pain and improve comfort and healing at the palatal donor site compared with a palatal stent.
How similar studies have performed: Previous nonrandomized studies and case series have suggested that Ora-Aid can ease oral wound discomfort, but randomized comparisons with conventional palatal stents are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age * Systemically healthy * Patients with good oral hygiene * Patients with mucogingival defects scheduled for free gingival graft (FGG) Exclusion Criteria: * Pregnancy or breastfeeding * Severe gagging reflex * Smokers * Patients allergic to the materials used in the study
Where this trial is running
Cairo
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.