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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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.
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.
Faculty of Dentistry, Cairo University
Cairo, Egypt
RECRUITINGPostoperative Pain
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain, 1 indicates minimal pain, and 10 signifies severe pain. Patients will record their pain scores daily during the initial healing phase when pain is expected to be at its maximum level.
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively
Analgesic Consumption
Indirect measurement of postoperative pain through mean consumption of analgesics, recorded in milligrams. Patients will document their analgesic intake and report whether they required additional painkillers due to palatal pain since the procedure
Time frame: Daily for 7 days postoperatively
Wound Size
The size of the palatal donor site wound will be measured using a UNC-15 periodontal probe to the nearest 0.5 mm.
Time frame: Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21
Patient Satisfaction with Healing Process
Patient satisfaction regarding postoperative discomfort and bleeding will be assessed using a questionnaire based on a Visual Analogue Scale (VAS) of 100 mm.
Time frame: 1 week (Day 7) postoperatively
Color Match of Palatal Mucosa
The color of the palatal mucosa at the donor site will be assessed by comparing it with the adjacent and opposite side using an objective Visual Analogue Scale (VAS) score ranging from 0 to 10, where 0 indicates no color match and 10 indicates excellent color match with adjacent tissues. Assessment will be conducted by a clinician blinded to treatment group assignment.
Time frame: Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively
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