The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft harvest in diabetic patients and to compare them with those in non-diabetic patients. Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are: 1. If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics. 2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome. Participants will be asked: * Receive the procedure to treat their gingival recession defects * To attend follow-up visits at 7, 14, 30, and 90 days after treatment. * To provide different biological samples * To answer different questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.
College of Dentistry - University of Kentucky
Lexington, Kentucky, United States
Remaining wound area (RWA)
The RWA will be measured in square millimeters using software (Image J- NIH, Bethesda, Maryland, USA) at baseline (trans-operative) and 1, 2, 4, and 12 weeks after the surgery
Time frame: 3 months
Epithelialization - EPT
Standardized photographs will be taken after a disclosure solution (Disclosing Agent, Dentsply, Charlotte, NC, USA) application in the wound area at 1,2, 4, and 12 weeks postoperatively. The epithelialized area was calculated as the percentage of the original wound area using software (Image J- NIH, Bethesda, Maryland, USA) calibrated with a measuring scale in the palate.
Time frame: 3 months
Insomnia Severity Index Survey
The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.
Time frame: Baseline and up to 4 weeks
Tissue thickness - TT
An endodontic spreader with a stop rubber will be inserted at the center of the wound area until reaching the bone. The distance between the instrument tip and the rubber stopper will be measured with a digital caliper
Time frame: 3 months
Inflammatory markers
The wound exudate may be collected 1 week after the procedure. Two paper strips (periopaper, Oraflow, Inc.) per wound will be individually placed and left in position for 40-60 s each. Before sampling, the wound will be gently rinsed and dried using water and an air spray. Relative isolation will then be performed immediately. If contamination with blood or saliva occurs, the paper strip will be discarded, and a new sample will be collected. In sequence, both paper strips will be placed into Eppendorf tubes and stored at -80º Celsius for further processing of inflammatory markers by Multiplex assay
Time frame: 2 weeks
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