Palatal Shield Technique for Pain Reduction and Wound Healing After Free Gingival Graft Surgery
Palatal Donor Site Wound Healing · Postoperative Pain
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 28 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
palatal shield group
Collagen Sponge + Flowable Composite Palatal Shield
Procedure: Palatal Shield Technique Using Flowable Composite Resin
collagen sponge group
Collagen Sponge Stabilized With Sutures
Procedure: Collagen Sponge Dressing Stabilized With Sutures
Palatal Shield Technique Using Flowable Composite Resin PROCEDURE
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 PROCEDURE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
postoperative pain intensity
Time frame: 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
Secondary measures
palatal donor site wound size
Time frame: Immediately After Surgery and on Postoperative Days 1, 3, 7, 14, 21, and 30
Wound size will be assessed by measuring the length, width, and depth of the palatal donor site using a periodontal probe. Measurements will be recorded in millimeters (mm).
early palatal wound healing
Time frame: Postoperative Days 1, 3, 7, and 14
Early wound healing at the palatal donor site will be assessed by clinical visual inspection using the Early Wound Healing Index (EHI), as described by Wachtel et al. (2003). Healing will be evaluated using a categorical score ranging from 0 to 5, according to the study protocol
Palatal Donor Site Re-epithelialization
Time frame: Postoperative Days 1, 3, 7, and 14
Re-epithelialization of the palatal donor site will be assessed by clinical visual inspection using a 3-point categorical scale: 1 = No re-epithelialization, 2 = Partial re-epithelialization, and 3 = Complete re-epithelialization. Higher scores indicate more complete epithelial coverage, according to Keceli et al. (2015).
palatal donor site color match
Time frame: Postoperative Days 1, 3, 7, 14, 21, and 30
Palatal donor site color match will be assessed by visual comparison with the adjacent native palatal mucosa using a 4-point categorical Color Match Rating Scale: 1 = Poor, 2 = Fair, 3 = Good, and 4 = Excellent. The minimum score is 1 and the maximum score is 4. Higher scores indicate better color matching.
patient satisfaction
Time frame: Postoperative Days 1, 3, 7, 14, 21, and 30
Patient satisfaction will be evaluated using a three-item questionnaire assessing satisfaction with the surgical results, willingness to undergo the procedure again, and willingness to recommend the procedure to others. Responses will be recorded using a 7-point response scale.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Periodontology Clinics, Faculty of Dentistry, Cairo UniversityCairo, Cairo Governorate, EgyptRecruiting
Study team and timeline
- Lead sponsor
- Sameh Samy
- Study start
- Jun 5, 2026 Actual
- Primary completion
- 2027-03 Estimated
- Study completion
- 2027-03 Estimated
- First posted
- Nov 9, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Evaluation of Novel Palatal Shield Technique for Improved Donor Site Wound Healing After Free Gingival Graft Surgery: A Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026
