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

Not Applicable

Recruiting

• Conditions: Mucosal Erosion; Gingival Recession

• Registration Number: NCT06892496
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2025-03-07
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs	Up 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 designs	2 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 designs	2 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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States