Health TrialsbyHealthPanel

Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent

ConditionsPostoperative PainMucogingival DefectsGingival Recessions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years of age

Systemically healthy

Patients with good oral hygiene

Patients with mucogingival defects scheduled for free gingival graft (FGG)

Disqualifiers

Pregnancy or breastfeeding

Severe gagging reflex

Smokers

Patients allergic to the materials used in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ora-Aid Oral Wound Dressing

    Other intervention

    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.

  • Acrylic Resin Palatal Stent

    Device

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Palatal StentActive comparator 1 intervention
Group B: Ora-Aid Oral Wound DressingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
Apply now