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Starting soon Not applicable

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

NCT07590427 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-05-15

Condition(s) studied

Maxillofacial Reconstruction

Investigational drug(s) / intervention(s)

Lateral periosteal-muscular flap

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 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 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. 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in pain scores — up to 6 months
    Pain will be evaluated using a 10-cm visual analogue scale (VAS).
  • Change in aesthetic assessment — up to 6 months
    The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).

Trial sites (1)

FacilityCityRegionStatus
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt Alexandria Azarita
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07590427 on ClinicalTrials.gov ↗ ← All trials in Egypt