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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorAlexandria University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Lateral periosteal-muscular flap

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: lateral periosteal-muscular flap prospectivelyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain scores

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

Time frame
up to 6 months
2

Change in aesthetic assessment

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

Time frame
up to 6 months

Secondary outcomes

1

post-operative complication

Any signs of post operative complications will be recorded

Time frame
up to 6 months

Other outcomes

Sponsors and contacts

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