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

NCT07523802 | Recruiting DMC

• 1 other identifier: PER3-3-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Mucogingival Defects; Gingival Recessions

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

Outcome Measures

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.

  Days 1, 2, 3, 4, 5, 6, and 7 postoperatively

Secondary Outcomes (4)

• Analgesic Consumption

  Daily for 7 days postoperatively

• Wound Size

  Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21

• Patient Satisfaction with Healing Process

  1 week (Day 7) postoperatively

• Color Match of Palatal Mucosa

  Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively

Study Arms (2)

Palatal Stent

ACTIVE COMPARATOR

Participants in this arm will receive an acrylic resin palatal stent to cover the palatal donor site immediately after free gingival graft harvesting. The stent will be fabricated using alginate impression with two Adams clasps and wax relief between the canine and second molar to accommodate gauze placement. The stent will be retained for two weeks and removed at day 3 for wound evaluation before being replaced.

Device: Acrylic Resin Palatal Stent

Ora-Aid Oral Wound Dressing

EXPERIMENTAL

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.

Other: Ora-Aid Oral Wound Dressing

Interventions

Ora-Aid Oral Wound Dressing OTHER

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.

Also known as: Ora-Aid

Ora-Aid Oral Wound Dressing

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.

Also known as: Palatal Stent, Acrylic Stent

Palatal Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Systemically healthy
• Patients with good oral hygiene
• Patients with mucogingival defects scheduled for free gingival graft (FGG)

You may not qualify if:

• Pregnancy or breastfeeding
• Severe gagging reflex
• Smokers
• Patients allergic to the materials used in the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Gingival Recession

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

EG (1)