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RecruitingNCT07926516ClinicalTrials.gov record

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

Palatal Donor Site Wound Healing · Postoperative Pain

THE QUICK READ

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.
Understand screening

Treatment, groups and participation

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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.

Prepare your questions

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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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

A HUMAN NEXT STEP

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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