What this study is
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.
What's being tested
- Free gingival graft
Intervention · PROCEDURE
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.
Study details
- Official title
- Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Open and Closed Wounds
- Sponsor
- Mauro Santamaria
- Conditions
- Diabetes Mellitus · Gingival Recession, Generalized · Gingival Recession, Localized
- Enrolling
- 40 people
- Starts
- 2026-09-09
- Est. completion
- 2030-04
- Design
- Double-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCollege of Dentistry - University of Kentucky
Lexington, Kentucky, United States
- Mauro Pedrine Santamaria, DDS, Ms, PhD · Contact859 323 6297maurosantamaria@uky.edu
- Dawn Dawson · Contact859 323-5409dawn.dawson@uky.edu
Recruiting
Study team
Sponsor
Mauro Santamaria
Study ID IRB-109004
Principal investigator
Mauro Pedrine Santamaria, DDS, Ms, PhD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.