Clinical Trials in Italy / NCT06714760
Recruiting Not applicable

Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects

NCT06714760 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-01-11
Last updated
2024-12-04

Condition(s) studied

Oral Disease

Investigational drug(s) / intervention(s)

Reconstruction following parcellar resections of the mandibular gingival region

Reconstruction following parcellar resections of the mandibular gingival region: In our surgical approach, we have used periosteum, galea, or pericranium flaps for reconstruction of bone and tissue defects in the cervicofacial region, with excellent results. To treat mandibular osteoradionecrosis, we harvested periosteum flaps from the radius, demonstrating efficacy in bone regeneration. For minor defects, such as those of the nose, we used flaps from the medial femoral condyle, despite the complexity of harvesting. The cranial region, particularly the temporo-parietal area, offered excellent vascularization, allowing the use of revascularized flaps for reconstruction of the oral mucosa after removal of carcinomas. These flaps have also been effective in the treatment of pharyngeal fistulas, proving to be a functionally reliable solution for oral cavity and cervicofacial defects.

Study summary

The overall objective of this study is to evaluate the safety of using the galea and pericranium (fascio-periosteal) temporal flap in the reconstruction of mandibular gingival defects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged ≥18 years; * Patients with mandibular gingival defects involving the anterior or lateral aspect of the mandible; * Patients in whom basal structural integrity of the mandibular bone is maintained; * Patients with a minimum follow-up of 3 months; * Obtaining informed consent. Exclusion Criteria: • Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS - Azienda Ospedaliero Universitaria di Bologna Bologna Emilia-Romagna Recruiting

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06714760 on ClinicalTrials.gov ↗ ← All trials in Italy