Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

February 24, 2019 updated by: Marwa Sayed Abbass Ali, Cairo University

Patient Satisfaction Following Vertical Ramus Osteotomy After Mandibular Setback Fixed With Patients Specific Osteosynthesis and Immediate Mobilization Versus Vertical Ramus Osteotomy Fixed With MMFin Patients With Mandibular Prognanthism

Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate

Study Overview

Detailed Description

Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate

Interventions:

General operative procedures

Eligible patients will be randomized in equal proportions between the study group (customized plate fixation of VRO) and the control group (maxillomandibular fixation of VRO).

Patients of Both groups will be subjected to:

  1. Case history including personal data, medical, surgical history and family history
  2. Clinical examination .
  3. Radiographic examination in the form of cephalometric radiogragh .
  4. Preoperative laboratory tests (complete blood cell count, Hemoglobin count, coagulation profile, liver function, kidney function and blood glucose level).
  5. Preoperative anesthesia assessment for fitness for general anesthesia.

vertical ramus osteotmy fixed with customized plate

  • All cases will undergo one surgery under general anesthesia.
  • Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
  • Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to the inferior alveolar neurovascular bundle
  • 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
  • The setback will be simulated according to pre-planned measure
  • The customized bone plate is positioned to fix the proximal and distal segment together

vertical ramus osteotomy fixed with MMF.

  • All cases will undergo one surgery under general anesthesia.
  • incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
  • Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. The osteotomy is placed 5 mm anterior to the posterior border of the mandible to avoid injury to inferior alveolar neurovascular bundle.
  • Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position.

follow up clinical and radiographic evaluation will be performed at the first week postoperative then the patients will recalled for radiograghic evaluation at 2weeks and 2 months .finall follow up visit will be at 6 months postoperative

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All subjects were required:

  • Patients with mandibular prognanthism indicated for mandibular setback.
  • All ages >18 years
  • Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • Patients with good general condition allowing surgical procedure under general anesthesia.
  • Patients with physical and psychological tolerance

Exclusion Criteria:

  • History of mandibular trauma
  • Previous orthognathic surgery
  • Degenerative disease of temporomandibular joint
  • Craniofacial syndrome such as cleft lip or palate
  • Follow up period will be less than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Customized plate fixation

Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback

- intervention:

  • All cases will undergo one surgery under general anesthesia.
  • Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
  • The customized fixation plate is positioned to fix the proximal and distal segment together
  • All cases will undergo one surgery under general anesthesia.
  • Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
  • Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
  • The customized fixation plate is positioned to fix the proximal and distal segment together after setback
Other Names:
  • patient specific osteosynthesis
Active Comparator: maxillomandibular fixation

Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation

- intervention:

  • All cases will undergo one surgery under general anesthesia
  • incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint
  • All cases will undergo one surgery under general anesthesia.
  • incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
  • The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
  • Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position.
Other Names:
  • intermaxillary fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: immediately postoperative
Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied
immediately postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stability of Mandible
Time Frame: pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative
assessed by determining the differences between measurements of three mandibular reference points (B-point, menton, and pogonion) in relation to SNy ,SNx axis obtained at six different time points
pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 24, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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