NCT07500935

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mauro Santamaria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes Mellitus
• Gingival Recession, Generalized
• Gingival Recession, Localized

Interventions

Type	Name	Description
PROCEDURE	Free gingival graft	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2030-04-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States