- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Case history including personal data, medical, surgical history and family history
- Clinical examination .
- Radiographic examination in the form of cephalometric radiogragh .
- Preoperative laboratory tests (complete blood cell count, Hemoglobin count, coagulation profile, liver function, kidney function and blood glucose level).
- 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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Other Names:
|
Active Comparator: maxillomandibular fixation
Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation - intervention:
|
Other Names:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Malocclusion
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- Goal NO 5 , OMFS IV A3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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