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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590427
Enrollment
20
Registered
2026-05-15
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofacial Reconstruction

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.

Interventions

PROCEDURELateral 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

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scoresup to 6 monthsPain will be evaluated using a 10-cm visual analogue scale (VAS).
Change in aesthetic assessmentup to 6 monthsThe aesthetic results will be assessed as excellent (E), good (G), acceptable (A) and poor (P).

Secondary

MeasureTime frameDescription
post-operative complicationup to 6 monthsAny signs of post operative complications will be recorded

Countries

Egypt

Contacts

CONTACTMariam Ahmed, MSc
mariam.ahmed.dent@alexu.edu.eg01069646754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026