Using a specific flap technique to reconstruct oral cavity defects
Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06714760
This study tests a new way to fix mouth defects after tumor removal using a special flap technique to see if it works well and is safe for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Trial ID | NCT06714760 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of using the galea and pericranium flap for reconstructing defects in the mandibular gingival region following tumor excision. The approach involves utilizing free tissue transfers, which are known for their reliability in head and neck surgeries. The study aims to assess the outcomes of this reconstructive method, considering factors such as the patient's medical condition and the characteristics of the defects. Participants will be monitored for a minimum of three months post-surgery to evaluate the results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with mandibular gingival defects who have maintained the structural integrity of their mandibular bone.
Not a fit: Patients with a history of previous surgeries that have altered the superficial temporal vasculature may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could improve functional and aesthetic outcomes for patients undergoing oral cavity reconstruction.
How similar studies have performed: Previous studies have shown positive outcomes with similar reconstructive techniques, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna, Emilia-Romagna
- IRCCS - Azienda Ospedaliero Universitaria di Bologna — Bologna, Emilia-Romagna, Italy (RECRUITING)
Study contacts
- Principal investigator: Achille Tarsitano, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Achille Tarsitano, MD
- Email: achille.tarsitano2@unibo.it
- Phone: 051 214 3415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Disease