Study of Palatal Protection After Gum Grafting

This study is looking for volunteers aged 18 or older who need a gum graft (autogenous gingival graft) to help understand the best way to protect the roof of your mouth (palate) after the procedure. Researchers want to compare three different protective techniques: a vacuum-formed retainer (VFR), a 3-D printed acrylic resin stent (3DS), and a flowable resin composite stent (FRC). The main goal is to see which technique leads to less pain, swelling, and bleeding, and if you would be willing to have the procedure again. You might be eligible if you are generally healthy or have mild, controlled health conditions and need soft-tissue grafting for 1 to 3 teeth or implants. The study aims to enroll 56 participants.

Study design
This interventional study plans to enroll 56 participants to compare three different palatal protection techniques. It is not specified if the study is randomized or blinded.
What's involved
You would have photographs and intraoral scans of your palate taken at 14 days, 30 days, and 3 months after surgery. You will also complete questionnaires about your pain, swelling, and bleeding.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 months after their surgery to evaluate pain, swelling, bleeding, and willingness to retreat.

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NCT06892496

Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques

Recruiting
NAAges 18+InterventionalTreatment
Virginia Commonwealth University
~56 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Visual Analog scale (VAS) questionnaireVacuum-formed retainer (VFR) technique3-D printed acrylic resin stent (3DS) techniqueFlowable resin composite stent (FRC) techniquePhotographs of the patient's palateMeasuring graft dimensions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs
Measured over Up to 2 weeks post-operatively
+2 more outcomes measured
Mucosal Erosion
Gingival Recession
1 sites across 1 states
Virginia1
  • Rafael Amorim Cavalcanti de Siqueira · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Rafael Amorim Cavalcanti de Siqueira
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Eligibility criteria

Inclusion

At least 18 years of age
Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)
Sites with 1 to 3 teeth or implants requiring soft-tissue grafting
Minimum palatal thickness of 2 mm
Willing to participate and sign an informed consent

Exclusion

Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)
Pregnant patients
Patients with bleeding disorders or taking anticoagulants
Smokers
Patients with a history of palatal graft harvesting
  • Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designsUp to 2 weeks post-operatively

    Evaluate postoperative pain level by documenting the number of pain pills taken during the initial two weeks of the healing process.

  • Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs2 weeks, 1 month and 3 months post-operative

    Using a Visual Analog scale (VAS) questionnaire indicating the subject's perception of swelling and bleeding following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.

  • Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs2 weeks, 1 month and 3 months post-operative

    Using a Visual Analog scale (VAS) questionnaire indicating the subject's willingness to retreat following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.