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

NCT06714760 | Recruiting

• 1 other identifier: CMF-PC22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Disease

Outcome Measures

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

  18 months

Study Arms (1)

patient

EXPERIMENTAL

The study will involve patients referred to the Department of Maxillofacial Surgery, IRCCS Azienda Ospedaliero-Universitaria di Bologna who require simple reconstruction following parcellar resections of the mandibular gingival region. It is planned to recruit during the above period 5 patients who meet the following inclusion and exclusion criteria.

Procedure: Reconstruction following parcellar resections of the mandibular gingival region

Interventions

Reconstruction following parcellar resections of the mandibular gingival region PROCEDURE

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.

patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Achille Tarsitano, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Achille Tarsitano, MD

CONTACT

051 214 3415; achille.tarsitano2@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: January 11, 2025
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-10

Locations

IT (1)