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NCT06892496NARecruiting

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

Virginia Commonwealth University

Start Date

3/7/2025

Completion Date

7/1/2026

Summary

This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.

Detailed Description

This study aims to determine if there is a difference in subject-reported outcome measures (PROMs) when different palatal post-operative protection techniques are used during healing after an autogenous soft-tissue graft is harvested from the palate for periodontal and peri-implant plastic surgery. The secondary objective is to evaluate if there is a difference in the healing of the palatal tissue via photographic and 3D linear and volumetric changes analysis after using the different protective techniques. Furthermore, the study will evaluate the time needed for fabrication and intraoral adjustment of each protective barrier and professional preference among the techniques utilized.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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

Interventions

OTHER

Visual Analog scale (VAS) questionnaire

OTHER

Vacuum-formed retainer (VFR) technique

OTHER

3-D printed acrylic resin stent (3DS) technique

OTHER

Flowable resin composite stent (FRC) technique

OTHER

Photographs of the patient's palate

OTHER

Measuring graft dimensions

OTHER

Chairside Polymer Stent

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Conditions

Mucosal ErosionGingival Recession

Locations

Virginia Commonwealth University

Richmond, Virginia 232398

United States