NCT07470281

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

Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on 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 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Coronally Advance Flap associated with connective tissue graft (CAF+CTG)	A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2030-04-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States