Gingival Recessions, Mucogingival Defects, Postoperative Pain
Conditions
Keywords
Free Gingival Graft, Palatal Donor Site, Ora-Aid, Oral Wound Dressing, Palatal Stent, Postoperative Pain Management, Wound Healing, Periodontal Surgery, Graft Harvesting, Mucogingival Therapy
Brief 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).
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The operator (investigator performing the surgical procedure) and participants cannot be blinded due to the nature of the interventions (visible difference between Ora-Aid wound dressing and palatal stent). However, the outcomes assessor (co-supervisor) who evaluates all primary and secondary outcomes will be blinded to the treatment group assignment. The biostatistician analyzing the data will also be blinded to group allocation.
Intervention model description
This is a randomized clinical trial with a parallel-group design and 1:1 allocation ratio. Participants will be randomly assigned to one of two groups: the intervention group receiving Ora-Aid oral wound dressing at the palatal donor site, or the control group receiving an acrylic resin stent at the palatal donor site. Both groups will be followed for 42 days postoperatively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Days 1, 2, 3, 4, 5, 6, and 7 postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Consumption | Daily for 7 days postoperatively | 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 |
| Wound Size | Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21 | The size of the palatal donor site wound will be measured using a UNC-15 periodontal probe to the nearest 0.5 mm. |
| Patient Satisfaction with Healing Process | 1 week (Day 7) postoperatively | Patient satisfaction regarding postoperative discomfort and bleeding will be assessed using a questionnaire based on a Visual Analogue Scale (VAS) of 100 mm. |
| Color Match of Palatal Mucosa | Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively | 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. |
Countries
Egypt
Outcome results
None listed