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Not yet recruiting NCT07590427

Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth

No phase Interventional Maxillofacial Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lateral periosteal-muscular flap.
Who it may be relevant to
Registry conditions: Maxillofacial Reconstruction. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

the Versatility of Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth

Overview

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.

Interventions

  • Procedure Lateral periosteal-muscular flap
    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 t

Primary outcome measures

  • Change in pain scores [Time frame: up to 6 months]
  • Change in aesthetic assessment [Time frame: up to 6 months]
Secondary outcome measures (1)
  • post-operative complication [Time frame: up to 6 months]

Eligibility criteria

Inclusion criteria

  • Patients requiring reconstruction of small and medium sized FOM defects.

Exclusion criteria

  • Previous neck dissection.
  • Previous radiotherapy in the maxillofacial region.
  • Uncontrolled diseases that may contraindicate the surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alex — Alexandria

Identifiers

NCT: NCT07590427 · 1267/02/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗