Oral DiseaseNCT06714760
Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
A study testing Reconstruction following parcellar resections of the mandibular gingival region in people with Oral Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Disease
- What is being tested?
- Reconstruction following parcellar resections of the mandibular gingival region
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2025to 11 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138
Achille Tarsitano, MD, 051 214 3415 ext. +39, achille.tarsitano2@unibo.it
About this study
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.
Read the 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.
- Conditions
- Oral Disease
- Being tested
- Reconstruction following parcellar resections of the mandibular gingival region
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction following parcellar resections of the mandibular gingival regionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Reconstruction following parcellar resections of the mandibular gingival region |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start11 Jan 2025 (estimated)
- Primary completion11 Sep 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Achille Tarsitano, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714760
- Sponsor's protocol ID
- CMF-PC22
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
- ClinicalTrials.gov ID
- NCT06714760
- Acronym / sponsor ID
- CMF-PC22
- Conditions
- Oral Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Jan 2025 (estimated)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Procedure: Reconstruction following parcellar resections of the mandibular gingival regionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconstruction following parcellar resections of the mandibular gingival regionIn 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. | Procedure or surgery | patient |
Primary outcome
outcomes
Time frame: 18 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Achille Tarsitano, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction following parcellar resections of the mandibular gingival region in people with Oral Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Achille Tarsitano, MD (051 214 3415 ext. +39, achille.tarsitano2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcomes (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.