Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis

NCT03278041 | Unknown DMC

• 1 other identifier: 454
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quality of life

  measured by University of Washington Head and Neck questionnaire(UW-QOL).

  one months post operative

Study Arms (2)

surgical reconstruction with submental flap

EXPERIMENTAL

surgical reconstruction with submental flap

Procedure: Submental flap for palatal reconstruction

maxillary obturator

ACTIVE COMPARATOR

maxillary obturator

Device: maxillary obturator

Interventions

Submental flap for palatal reconstruction PROCEDURE

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.

surgical reconstruction with submental flap

maxillary obturator DEVICE

immediate surgical obturator

maxillary obturator

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects were required:
• All patients suffering from midface defects that involving palatal-maxillary bone are included.
• All ages and both sexes were included in this study.
• Patients with good general condition allowing major surgical procedure under general anesthesia.
• Be physically and psychologically able to tolerate procedures.
• Be cooperative to return for follow-up, examinations and evaluation.

You may not qualify if:

• Patient who physically and psychologically not able to tolerate procedures. Because they cannot able to tolerate procedures and may discontinue the follow-up visits.
• Be Uncooperative to return for follow-up, examinations and evaluation.
• Patients with any systemic disease (e.g uncontrolled diabetic, bisphosphonates …..ect) because that may affect normal healing.
• Patient with bad oral hygiene.Because poor oral hygiene can cause inflammation which induces pain that effect outcome reading.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry-cairo university

Cairo, 311, Egypt

RECRUITING

Central Study Contacts

omar Q Aladashi, Master

CONTACT

00201154639509; omraladashi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigator AlAdashi O nor Participants can be blinded. Similarly, the Assessor (Participants) can't be blinded. The statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: January 30, 2018
• Primary Completion: December 30, 2018
• Study Completion: January 30, 2019
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

EG (1)