Clinical trial NCT06892496: Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Official title: Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mucosal Erosion
Gingival Recession
Keywords: soft tissue graft
pain
wound healing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will assign randomly which palatal post-operative protection technique the patient will undergo by utilizing a dedicated software (Research Randomizer). The study team will then initiate the fabrication of the palatal stent in cases where VFR or 3DS groups are assigned to the patient.
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs
timeFrame: Up to 2 weeks post-operatively
measure: Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs
timeFrame: 2 weeks, 1 month and 3 months post-operative
measure: Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs
timeFrame: 2 weeks, 1 month and 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Rafael Amorim Cavalcanti de Siqueira
role: PRINCIPAL_INVESTIGATOR
References: