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Clinical Trials in Egypt / NCT07926516
Recruiting Not applicable

Palatal Shield Technique for Pain Reduction and Wound Healing After Free Gingival Graft Surgery

NCT07926516 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sameh Samy
Phase
Not applicable
Started
2026-06-05
Last updated
2026-11-09

Condition(s) studied

Palatal Donor Site Wound HealingPostoperative Pain

Investigational drug(s) / intervention(s)

Palatal Shield Technique Using Flowable Composite ResinCollagen Sponge Dressing Stabilized With Sutures

Palatal Shield Technique Using Flowable Composite Resin: A resorbable collagen sponge is placed over the palatal donor site following free gingival graft harvesting and stabilized with sutures. Flowable composite resin is then applied and light-cured to form a protective palatal shield retained by the adjacent teeth.

Collagen Sponge Dressing Stabilized With Sutures: Following free gingival graft harvesting, a resorbable collagen sponge is trimmed to fit the palatal donor site and stabilized using sutures without additional composite resin coverage.

Study summary

This randomized controlled clinical trial aims to evaluate the effectiveness of a novel palatal shield technique in reducing postoperative pain and improving wound healing after free gingival graft surgery.

A total of 28 adult participants undergoing palatal tissue harvesting are planned to be enrolled and randomly assigned to two groups.

The experimental group receives a collagen sponge covered by a protective palatal shield made of flowable composite resin, while the control group receives a collagen sponge stabilized with sutures alone.

The primary outcome is postoperative pain, assessed using a 0-10 pain scale. Secondary outcomes include wound size, early wound healing, re-epithelialization, tissue color match, and patient satisfaction.

Postoperative clinical assessments are planned through 30 days after surgery. The study aims to determine whether the palatal shield technique provides better pain control and wound healing compared with conventional collagen sponge dressing.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged 18 years or older. * Patients with no history of previous palatal tissue harvesting. * Patients demonstrating good compliance with plaque control instructions following initial periodontal therapy. * Patients requiring soft tissue augmentation using free gingival grafts (FGG) or de-epithelialized free gingival grafts for gingival recession coverage, vestibuloplasty, or increasing the width of keratinized tissue around teeth. * Patients providing informed consent to participate in the study. Exclusion Criteria: - Patients with systemic diseases. * Pregnant or breastfeeding women. * Patients with oral lesions involving the palate. * Patients using dental prostheses covering the palate. * Smokers. * Patients taking anticoagulant medications. * Patients with abnormalities affecting the wound healing process.

Primary outcome measure(s)

  • postoperative pain intensity — Postoperative Days 1, 3, 7, 14, 21, and 30
    Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity

Trial sites (1)

FacilityCityRegionStatus
Periodontology Clinics, Faculty of Dentistry, Cairo University Cairo Cairo Governorate Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07926516 on ClinicalTrials.gov ↗ ← All trials in Egypt