🏛️ Verified NIH Record • Updated 2026-08-21

Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial (NCT07500935)

Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Open and Closed Wounds

🟡 Not Yet Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Mauro Santamaria

🩺 Plain-English Summary (8th-Grade Level)

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 can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).

Location: College of Dentistry - University of Kentucky — Lexington, Kentucky

Age range: 18 Years

🧪 Interventions in This Study

  • Free gingival graft (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • College of Dentistry - University of Kentucky — Lexington, Kentucky

📞 Contact the Study Coordinator

Phone: (859) 323-5409

Email: dawn.dawson@uky.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗