Periosteal Muscular Flap in Reconstruction of Small and Medium Sized Defects at Floor of the Mouth
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Azarita |
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View NCT07590427 on ClinicalTrials.gov ↗ ← All trials in Egypt