Free Gingival Graft for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Mauro Pedrine Santamaria, DDS, Ms, PhD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the procedure to treat their gingival recession defects
Follow-up
Participants are monitored for wound healing and epithelialization at 7, 14, 30, and 90 days after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Free Gingival Graft
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Diabetic 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.
Non-diabetic 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mauro Santamaria
Lead Sponsor
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