Palatal Wound Healing After Free Gingival Graft in Diabetic Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares palatal mucosal healing after free gingival graft harvest between diabetic and non-diabetic adults with gingival recession. Participants will undergo the graft procedure and have follow-up visits at 7, 14, 30, and 90 days with collection of biological samples and questionnaires. The study will analyze wound area, epithelialization, oral microbiome, and inflammatory markers to identify factors associated with healing outcomes. The trial is conducted at the College of Dentistry, University of Kentucky, led by Mauro Santamaria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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);
* no morphological or pathological conditions in the palatal mucosa.

Exclusion Criteria:

* 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;
* subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
* prisoners;
* signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
* subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter

Where it's running

• College of Dentistry - University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Mauro Pedrine Santamaria, DDS, Ms, PhD — University of Kentucky
• Study coordinator: Dawn G Dawson
• Email: dawn.dawson@uky.edu
• Phone: 8593235409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.