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

November 5, 2026 updated by: Sameh Samy

Evaluation of Novel Palatal Shield Technique for Improved Donor Site Wound Healing After Free Gingival Graft Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Governorate
      • Cairo, Cairo Governorate, Egypt
        • Recruiting
        • Periodontology Clinics, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: palatal shield group

Collagen Sponge + Flowable Composite Palatal Shield
Procedure: 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.
Active Comparator: collagen sponge group

Collagen Sponge Stabilized With Sutures
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Postoperative Days 1, 3, 7, 14, 21, and 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Immediately After Surgery and on Postoperative Days 1, 3, 7, 14, 21, and 30
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
Postoperative Days 1, 3, 7, and 14
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).
Postoperative Days 1, 3, 7, and 14
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.
Postoperative Days 1, 3, 7, 14, 21, and 30
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.
Postoperative Days 1, 3, 7, 14, 21, and 30

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sameh Samy

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PER 3-3-1-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with external researchers. Study data will be accessible only to the principal investigator and supervisors and will be stored securely to protect participant confidentiality.

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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