NCT03855072

Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	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
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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-01-01
• Completion: 2022-08-01
• First posted: 2019-02-26
• Last updated: 2019-02-26