About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients requiring reconstruction of small and medium sized FOM defects.
Disqualifiers
Previous neck dissection.
Previous radiotherapy in the maxillofacial region.
Uncontrolled diseases that may contraindicate the surgery
Trial design
Single group
Treatments tested in this trial
Lateral periosteal-muscular flap
Procedure/SurgeryFollowing 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in pain scores
Pain will be evaluated using a 10-cm visual analogue scale (VAS).
Change in aesthetic assessment
The aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).
Secondary outcomes
post-operative complication
Any signs of post operative complications will be recorded
Sponsors and contacts
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