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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial

Mauro Santamaria · NCT07500935

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
1
Study start
September 9, 2026
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics.
  • 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.

Being studied: Free gingival graft

Conditions: Diabetes Mellitus; Gingival Recession, Generalized; Gingival Recession, Localized

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • College of Dentistry - University of Kentucky

    Lexington, KY 40536

    Site contact: Mauro Pedrine Santamaria, DDS, Ms, PhD · 859 323 6297 · maurosantamaria@uky.edu

Study contacts (from the official record)

  • Dawn G Dawson · 8593235409 · dawn.dawson@uky.edu
All diabetes studies in Kentucky →
Palatal Wound Healing After Free Gingival Graft Harvest in… (NCT07500935) | Bored Studies