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

ConditionOral Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Reconstruction following parcellar resections of the mandibular gingival region

    Procedure/Surgery

    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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: patientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

outcomes

Number and % of patients with adequate flap viability, defined as effective vascular supply and complete rooting of the flap at the recipient site, without tissue necrosis. Partial viability will be considered as incomplete rooting of the flap with associated peripheral tissue necrosis affecting less than 1/3 of the surface de

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.