Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial

NCT06892496 NA RECRUITING

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.

Details

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	RECRUITING
Enrolment	56
Start date	2025-03-07
Completion	2026-07

Conditions

• Mucosal Erosion
• Gingival Recession

Interventions

• Visual Analog scale (VAS) questionnaire
• Vacuum-formed retainer (VFR) technique
• 3-D printed acrylic resin stent (3DS) technique
• Flowable resin composite stent (FRC) technique
• Photographs of the patient's palate
• Measuring graft dimensions
• Chairside Polymer Stent

Primary outcomes

• 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.

Countries

United States