Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment 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 gingival recession reduction and percentage of root coverage 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, 90, and 180 days after treatment.
• To provide different biological samples
• To answer different questionnaires.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Mauro Santamaria

Study start

Sep 18, 2026 Actual

Primary completion

2029-04 Estimated

Study completion

2030-04 Estimated

First posted

Mar 13, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts