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Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis

NCT03278041 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-09-11

No results posted yet for this study

Summary

The aim of the study is to compare maxillary obturator versus submental artery flap after partial maxillectomy in the aspect of Quality of life outcomes.

Conditions

  • Patient With Partial Maxillectomy
  • Submental Island Flap
  • Maxillary Obturator

Interventions

PROCEDURE

Submental flap for palatal reconstruction

Under General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by : Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape. * 1st step will be identify the facial artery and vein, * 2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein. * 3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision . The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture.

DEVICE

maxillary obturator

immediate surgical obturator

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2018-12-30
Completion
2019-01-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278041 on ClinicalTrials.gov