The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment 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 gingival recession reduction and percentage of root coverage 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, 90, and 180 days after treatment. * To provide different biological samples * To answer different questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ
College of Dentistry - University of Kentucky
Lexington, Kentucky, United States
gingival recession reduction
The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values
Time frame: 6 months
Probing depth
measured in millimeters using a periodontal probe at the mid-buccal aspect
Time frame: 6 month
Clinical attachment level
measured as probing depth + gingival recession
Time frame: 6 months
PROMIS Adult Sleep Disturbance Survey
The Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey has each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: Baseline and up to 4 weeks
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
Change in Dentin hypersensitivity
The participants may be asked about the dentin hypersensitivity in the gingival recession site after a 3-second air blast and self-report esthetic perceptions before the surgery and 3 and 6 months after the surgical protocol.
Time frame: Baseline and up to 6 months
Number of analgesics
Number of analgesics taken on the current day for 7 days.
Time frame: 7 days
Discomfort
Participants will be asked to report the discomfort level using a visual analog scale for 7 days after the surgery. Scale ranges from 0 to 10 with a higher score equating to increased discomfort.
Time frame: 7 days
Root Coverage Esthetic Score
The aesthetics of the site will be assessed using the Root Coverage Esthetic - RES Score visually with score (0 "minimum" - 10 "maximum"). A higher score equates to a better esthetic outcome.
Time frame: 6 months
gingival crevicular fluid (GCF) inflammatory markers
The gingival crevicular fluid (GCF) may be collected from the Gingival Recession defect sites before the surgery (visit 1), and 1-,2-, 4-, 12-, 24-weeks after the procedure. Two paper strips (periopaper, Oraflow, Inc.) will be inserted gently into the sulcus for 30 seconds. Before sampling, the area will be gently rinsed and dried using water and an air spray.
Time frame: 6 months
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