Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMauro Santamaria
About 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.
Eligibility criteria
Qualifiers
aged ≥ 18 years;
non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
periodontal stable (BoP ≤25%)(Lang et al. 2003);
Disqualifiers
patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
Pregnancy/lactation (assessed via self-report);
current opportunistic oral lesions that mainly colonize the palate region;
Trial design
Treatments tested in this trial
- Free gingival graft
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mauro Santamaria
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov