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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06714760
Enrollment
5
Registered
2024-12-04
Start date
2025-01-11
Completion date
2026-11-11
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Disease

Brief 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.

Detailed description

Reconstruction with free flaps is a routine practice in head and neck surgery because of better functional, aesthetic results and generally higher success rates. Current applications of this practice include reconstructive surgeries that follow excisions of neoplastic lesions involving the oral cavity. Following resection of the primary tumor, reconstructive surgery is usually necessary in order to restore function to the oral cavity. The most appropriate reconstructive method is determined by several factors, including the characteristics of the defects and primary tumor site, the general medical condition, the patient's social history, the prognosis, and the surgeon's expertise. Reconstructive methods usually follow a reconstructive ladder, starting with a skin graft and ending with a microvascular free flap. Free tissue transfers are currently one of the most popular and reliable techniques for oral reconstruction. The use of periosteal flaps for reconstruction of bone defects has been described by several authors. In particular, a well-known technique by Bettoni et al. \[5\] demonstrated excellent results, also in terms of bone regeneration, following the use of free periosteum flaps taken from radius in the treatment of osteoradionecrosis of mandible. Free flaps of periosteum and osteoperiosteum of the medial femoral condyle have also been widely used for minimal bone reconstructions, such as those of the nasal bone, again with excellent results . However, harvesting these flaps is complex and the periosteum obtained is small in size. Based on the assumption that the cranial region would provide surgeons with more options in terms of harvesting periosteum flaps to reconstruct soft and hard tissue defects, previous clinical experiences have explored the possibility of harvesting a galea and pericranium flap for reconstruction of oral mucosal defects resulting from excision of squamous cell carcinomas, obtaining positive results. Indeed, the temporal region is an important donor site in reconstructive surgery of the head and neck region, from which pedicled flaps of muscle, fascia, and skin can be harvested. In particular, the vascular supply of the pericranial temporo-parietal region was evaluated in the above experience. Previous clinical experience has demonstrated the efficacy of such a flap, used for the treatment of pharyngeal fistulas, as a revascularized free graft. In conclusion, this type of flap has been shown to be functionally reliable for defects of the cervicofacial district, so we propose to apply it to parcellar defects of the oral cavity.

Interventions

PROCEDUREReconstruction 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.

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
outcomes18 monthsNumber 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

Countries

Italy

Contacts

Primary ContactAchille Tarsitano, MD
achille.tarsitano2@unibo.it051 214 3415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026