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

NCT07590427 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-15

No results posted yet for this 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.

Conditions

  • Maxillofacial Reconstruction

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 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.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07590427 on ClinicalTrials.gov