Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients

This study is looking at how well the roof of the mouth (palate) heals after a procedure called a free gingival graft (FGG) in people with diabetes compared to those without diabetes. The FGG involves taking a small piece of tissue from your palate to treat gum recession. Researchers want to see if diabetes affects how quickly the wound heals and if other factors like oral germs (microbiome) or inflammation play a role. You may be able to join if you are 18 or older, have gum recession, and either have diabetes (managed with medication) or do not have diabetes. The study will measure the remaining wound area after 3 months to see how well healing has progressed.

Study design: This interventional study plans to enroll 40 participants, including both diabetic and non-diabetic individuals with gum recession.
What's involved: Participants will undergo a procedure where a free gingival graft is harvested from the palate. The study will then track the healing of this wound.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 3 months to measure the remaining wound area.

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

Not Yet Recruiting

NAAges 18+InterventionalBasic science

Mauro Santamaria

~40 participants

Updated 2026-08-24 on ClinicalTrials.gov

What's tested:Free gingival graft

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Remaining wound area (RWA)

Measured over 3 months

Conditions

Diabetes Mellitus

Gingival Recession, Generalized

Gingival Recession, Localized

Where it's being run

1 sites across 1 states

Kentucky1

Study leadership

Mauro Pedrine Santamaria, DDS, Ms, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Dawn G Dawson

[email protected]

8593235409

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Remaining wound area (RWA)3 months
The RWA will be measured in square millimeters using software (Image J- NIH, Bethesda, Maryland, USA) at baseline (trans-operative) and 1, 2, 4, and 12 weeks after the surgery

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