Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

NCT ID: NCT03855072

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-08-31

Brief Summary

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

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

Conditions

Mandibular Prognathism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

customized fixation plate

Intervention Type: PROCEDURE

• 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

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

Group Type: ACTIVE_COMPARATOR

maxillomandibular fixation

Intervention Type: PROCEDURE

• 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.

Interventions

customized fixation 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.
• 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

Intervention Type: PROCEDURE

maxillomandibular fixation

• 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.

Intervention Type: PROCEDURE

Other Intervention Names

patient specific osteosynthesis; intermaxillary fixation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Sayed Abbass Ali

associate lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Goal NO 5 , OMFS IV A3

Identifier Type: -

Identifier Source: org_study_id