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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
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.
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGEvaluate 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-operatively
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-operative
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-operative
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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.
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
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.
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.