Palatal Donor Site Wound HealingNCT07926516
Palatal Shield Technique for Pain Reduction and Wound Healing After Free Gingival Graft Surgery
A study testing Palatal Shield Technique Using Flowable Composite Resin and Collagen Sponge Dressing Stabilized With Sutures in people with Palatal Donor Site Wound Healing and Postoperative Pain, run by Sameh Samy at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palatal Donor Site Wound Healing, Postoperative Pain
- What is being tested?
- Palatal Shield Technique Using Flowable Composite Resin and Collagen Sponge Dressing Stabilized With Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Periodontology Clinics, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate
sameh s Hassan, BDS, +201014142357, sameh.samy@dentistry.cu.edu.eg
About this study
Official title: 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.
Read more
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.
- Being tested
- Palatal Shield Technique Using Flowable Composite Resin, Collagen Sponge Dressing Stabilized With Sutures
- Keywords
- Palatal Shield, Palatal Wound Healing, Free Gingival Graft, Flowable Composite Resin, Collagen Sponge, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal Shield Technique Using Flowable Composite ResinProcedure or surgery
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 SuturesProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| palatal shield group | Experimental | Collagen Sponge + Flowable Composite Palatal Shield Receives: Procedure: Palatal Shield Technique Using Flowable Composite Resin |
| collagen sponge group | Active comparator | Collagen Sponge Stabilized With Sutures Receives: Procedure: Collagen Sponge Dressing Stabilized With Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity
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
Measured: Postoperative Days 1, 3, 7, 14, 21, and 30
Secondary outcomes (5)
palatal donor site wound size
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).
Measured: Immediately After Surgery and on Postoperative Days 1, 3, 7, 14, 21, and 30
early palatal wound healing
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
Measured: Postoperative Days 1, 3, 7, and 14
Palatal Donor Site Re-epithelialization
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).
Measured: Postoperative Days 1, 3, 7, and 14
palatal donor site color match
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.
Measured: Postoperative Days 1, 3, 7, 14, 21, and 30
patient satisfaction
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.
Measured: Postoperative Days 1, 3, 7, 14, 21, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start5 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Donor Site Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated into two parallel groups in a 1:1 ratio. The experimental group will receive a collagen sponge covered with a flowable composite resin palatal shield, while the control group will receive a collagen sponge stabilized with sutures alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sameh Samy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Samy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926516
- Sponsor's protocol ID
- PER 3-3-1-1
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Palatal Shield Technique for Improved Donor Site Wound Healing After Free Gingival Graft Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07926516
- Acronym / sponsor ID
- PER 3-3-1-1
- Keywords
- Palatal Shield, Palatal Wound Healing, Free Gingival Graft, Flowable Composite Resin, Collagen Sponge, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sameh SamyUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated into two parallel groups in a 1:1 ratio. The experimental group will receive a collagen sponge covered with a flowable composite resin palatal shield, while the control group will receive a collagen sponge stabilized with sutures alone.
| Arm | Type | Receives |
|---|---|---|
| palatal shield group | Experimental | Procedure: Palatal Shield Technique Using Flowable Composite ResinCollagen Sponge + Flowable Composite Palatal Shield |
| collagen sponge group | Active comparator | Procedure: Collagen Sponge Dressing Stabilized With SuturesCollagen Sponge Stabilized With Sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palatal Shield Technique Using Flowable Composite ResinA 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. | Procedure or surgery | palatal shield group |
| Collagen Sponge Dressing Stabilized With SuturesFollowing 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. | Procedure or surgery | collagen sponge group |
Primary outcome
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
5 secondary outcomes
palatal donor site wound size
Time frame: 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
Palatal Donor Site Re-epithelialization
Time frame: Postoperative Days 1, 3, 7, and 14
palatal donor site color match
Time frame: Postoperative Days 1, 3, 7, 14, 21, and 30
patient satisfaction
Time frame: Postoperative Days 1, 3, 7, 14, 21, and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Periodontology Clinics, Faculty of Dentistry, Cairo University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal Shield Technique Using Flowable Composite Resin and Collagen Sponge Dressing Stabilized With Sutures in people with Palatal Donor Site Wound Healing and Postoperative Pain, run by Sameh Samy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain intensity (time frame: Postoperative Days 1, 3, 7, 14, 21, and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.