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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Reconstruction following parcellar resections of the mandibular gingival region
Procedure/SurgeryIn 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
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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