Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Visual Analog scale (VAS) questionnaire
Other interventionA 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.
Vacuum-formed retainer (VFR) technique
Other interventionOn 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.
3-D printed acrylic resin stent (3DS) technique
Other interventionOn 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.
Flowable resin composite stent (FRC) technique
Other interventionOn 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
Photographs of the patient's palate
Other interventionAt 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.
Measuring graft dimensions
Other interventionThe 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.
Chairside Polymer Stent
Other interventionThe 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.
Treatment groups
56 Participants
are divided into 4 treatment groupsGroup A: Vacuum-formed retainer (VFR): plastic deviceExperimental treatment 4 interventions
Group B: 3-D printed acrylic resin stent (3DS): digitally designedExperimental treatment 4 interventions
Group C: Flowable resin composite stent (FRC): mechanical barrierExperimental treatment 4 interventions
Group D: Chairside Polymer Stent:CPS: mechanical barrierExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs
Evaluate postoperative pain level by documenting the number of pain pills taken during the initial two weeks of the healing process.
Time frame
Up to 2 weeks post-operatively2
Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs
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.
Time frame
2 weeks, 1 month and 3 months post-operative3
Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs
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.
Time frame
2 weeks, 1 month and 3 months post-operativeSponsors and contacts
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Source ClinicalTrials.gov