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

NCT07590427 | Not Yet Recruiting

• 1 other identifier: 1267/02/26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in pain scores

  Pain will be evaluated using a 10-cm visual analogue scale (VAS).

  up to 6 months

• Change in aesthetic assessment

  The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).

  up to 6 months

Secondary Outcomes (1)

• post-operative complication

  up to 6 months

Study Arms (1)

lateral periosteal-muscular flap prospectively

EXPERIMENTAL

Procedure: Lateral periosteal-muscular flap

Interventions

Lateral periosteal-muscular flap PROCEDURE

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.

lateral periosteal-muscular flap prospectively

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

Central Study Contacts

Mariam Ahmed, MSc

CONTACT

01069646754; mariam.ahmed.dent@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

EG (1)