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

Overview

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.

Interventions

• Other Visual Analog scale (VAS) questionnaire
  A Visual Analog Scale (VAS) questionnaire is a type of self-report tool where respondents mark a point on a continuous line to indicate the intensity of a subjective experience, like pain, fatigue, or happiness, 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.
• Other Vacuum-formed retainer (VFR) technique
  On the day of surgery, the stent will be positioned to cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. Vacuum-formed retainers are a common clinical practice used after harvesting a palatal graft, in order to provide a mechanical barrier to reduce post-operative pain.
• Other 3-D printed acrylic resin stent (3DS) technique
  On the day of surgery, the previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.
• Other Flowable resin composite stent (FRC) technique
  On the day of surgery, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity
• Other Photographs of the patient's palate
  At the 14-day, 30-day and 3-month follow-up visits, photographs of the patient's palate (Canon EOS 60D DSLR, Canon, USA) will be taken for healing evaluation as well as intraoral scans (TRIOS 4, 3Shape) of the palatal wound for linear and volumetric changes analysis.
• Other Measuring graft dimensions
  The graft dimensions will be measured with the use of a periodontal probe and recorded on the data collection form. The professional preference in regard to technique applied and the time spent by the surgeon to adjust the stent intraorally will also be recorded in the same form.
• Other Chairside Polymer Stent
  The stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.

Primary outcome measures

• Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs [Time frame: Up to 2 weeks post-operatively]
• Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs [Time frame: 2 weeks, 1 month and 3 months post-operative]
• Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs [Time frame: 2 weeks, 1 month and 3 months post-operative]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06892496 · HM20028832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗