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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 24
- Primary Endpoint
- Patient Satisfaction
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: customized fixation plate (Procedure)
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
Intervention: maxillomandibular fixation (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- stability of Mandible(pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative)
Investigators
Marwa Sayed Abbass Ali
associate lecturer
Cairo University