Maxillofacial ReconstructionNCT07590427
Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
A study testing Lateral periosteal-muscular flap in people with Maxillofacial Reconstruction, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Rebuilding head and neck defects is a chief challenge to the maxillofacial surgeons especially after cancer resection, trauma, infection and craniofacial deformities. Earlier, the use of obturators for many years has been a successful treatment plan. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Maxillofacial Reconstruction
- What is being tested?
- Lateral periosteal-muscular flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Jun 2027
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring reconstruction of small and medium sized FOM defects.
Who cannot join
- Previous neck dissection.
- Previous radiotherapy in the maxillofacial region.
- Uncontrolled diseases that may contraindicate the surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
Faculty of Dentistry, (203) 4868308
Mariam Ahmed, MSc
About this study
Official title: the Versatility of Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
Background: Rebuilding head and neck defects is a chief challenge to the maxillofacial surgeons especially after cancer resection, trauma, infection and craniofacial deformities. Earlier, the use of obturators for many years has been a successful treatment plan. However, recently several surgical modalities are available for the restoration of such defects as locoregional or microvascular free flaps.
Aim: To assess the reliability of the lateral periosteal-muscular flap in the reconstruction of small and medium sized floor of the mouth defects.
Main outcome: To evaluate functional outcomes (Including speech, tongue mobility, deglutition, flap viability), pain, complications such as trismus, flap necrosis, dehiscence, infection, fistula formation or donor site morbidity and aesthetic outcomes. Mean harvesting time and flap dimensions will be recorded.
- Conditions
- Maxillofacial Reconstruction
- Being tested
- Lateral periosteal-muscular flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral periosteal-muscular flapProcedure or surgery
Following tumor resection and neck dissection, the floor of mouth defect was assessed, and the marginal mandibular nerve was carefully preserved. An inferiorly based rectangular periosteal flap was designed on the lateral surface of the mandible. The flap was elevated using a periosteal elevator while maintaining its inferior vascular pedicle. Additional lingual dissection was performed when extra length was required. The flap was then rotated to the lingual side of the mandible to reconstruct the floor of mouth defect and secured using 3/0 Vicryl sutures. Saline irrigation was used intraorally to confirm complete sealing without neck leakage. Flap dimensions and harvesting time were recorded.
| Study group | Role | What they receive |
|---|---|---|
| lateral periosteal-muscular flap prospectively | Experimental | Not described Receives: Procedure: Lateral periosteal-muscular flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Pain will be evaluated using a 10-cm visual analogue scale (VAS).
Measured: up to 6 months
Change in aesthetic assessment
The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).
Measured: up to 6 months
Secondary outcomes (1)
post-operative complication
Any signs of post operative complications will be recorded
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial ReconstructionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590427
- Sponsor's protocol ID
- 1267/02/26
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Versatility of Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
- ClinicalTrials.gov ID
- NCT07590427
- Acronym / sponsor ID
- 1267/02/26
- Conditions
- Maxillofacial Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 May 2026 (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.
Background: Rebuilding head and neck defects is a chief challenge to the maxillofacial surgeons especially after cancer resection, trauma, infection and craniofacial deformities. Earlier, the use of obturators for many years has been a successful treatment plan. However, recently several surgical modalities are available for the restoration of such defects as locoregional or microvascular free flaps.
Aim: To assess the reliability of the lateral periosteal-muscular flap in the reconstruction of small and medium sized floor of the mouth defects.
Main outcome: To evaluate functional outcomes (Including speech, tongue mobility, deglutition, flap viability), pain, complications such as trismus, flap necrosis, dehiscence, infection, fistula formation or donor site morbidity and aesthetic outcomes. Mean harvesting time and flap dimensions will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lateral periosteal-muscular flap prospectively | Experimental | Procedure: Lateral periosteal-muscular flap |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients requiring reconstruction of small and medium sized FOM defects.
Key exclusion criteria (3 listed)
- Previous neck dissection.
- Previous radiotherapy in the maxillofacial region.
- Uncontrolled diseases that may contraindicate the surgery
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 |
|---|---|---|
| Lateral periosteal-muscular flapFollowing tumor resection and neck dissection, the floor of mouth defect was assessed, and the marginal mandibular nerve was carefully preserved. An inferiorly based rectangular periosteal flap was designed on the lateral surface of the mandible. The flap was elevated using a periosteal elevator while maintaining its inferior vascular pedicle. Additional lingual dissection was performed when extra length was required. The flap was then rotated to the lingual side of the mandible to reconstruct the floor of mouth defect and secured using 3/0 Vicryl sutures. Saline irrigation was used intraorally to confirm complete sealing without neck leakage. Flap dimensions and harvesting time were recorded. | Procedure or surgery | lateral periosteal-muscular flap prospectively |
Primary outcome
Change in pain scores
Time frame: up to 6 months
Pain will be evaluated using a 10-cm visual analogue scale (VAS).
Change in aesthetic assessment
Time frame: up to 6 months
The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).
1 secondary outcome
post-operative complication
Time frame: up to 6 months
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 15 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral periosteal-muscular flap in people with Maxillofacial Reconstruction, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 May 2026. 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 Egypt. 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 Mariam Ahmed, MSc (01069646754, mariam.ahmed.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 15 May 2026.