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

April 9, 2026 updated by: Ahmed Sabry, Cairo University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Recruiting
        • Faculty of Dentistry, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palatal Stent
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
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.
Other Names:
  • Palatal Stent
  • Acrylic Stent
Experimental: Ora-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.
Other: Ora-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.
Other Names:
  • Ora-Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 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.
Days 1, 2, 3, 4, 5, 6, and 7 postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Consumption
Time Frame: 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
Daily for 7 days postoperatively
Wound Size
Time Frame: 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.
Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21
Patient Satisfaction with Healing Process
Time Frame: 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.
1 week (Day 7) postoperatively
Color Match of Palatal Mucosa
Time Frame: 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.
Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER3-3-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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