Using a specific flap technique to reconstruct oral cavity defects
Official title: Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06714760 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Status | Recruiting |
| Started | January 11, 2025 |
| Main results expected | September 11, 2026 |
| Study ends | November 11, 2026 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT06714760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with mandibular gingival defects who have maintained the structural integrity of their mandibular bone.
✕Probably not a fit
Patients with a history of previous surgeries that have altered the superficial temporal vasculature may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown positive outcomes with similar reconstructive techniques, indicating a promising approach.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.