Comparison Between Internal and External Distractors in Osteogenesis
NCT03540329 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-05-30
Summary
Distraction osteogenesis is a powerful technique for creating new bone during significant lengthening of the mandible without the need for bone grafting and associated donor site morbidity.
The idea of distraction osteogenesis was largely abandoned by many until the 1950s. Ilizarov minimized complications by performing a corticotomy with minimal disruption of the surrounding blood supply and using a system of tension ring fixators to control the distraction in multiple planes. Through a series of experimental studies and clinical applications, Ilizarov established the foundation of distraction osteogenesis and its role in orthopedic management.
Applications in craniofacial surgery were first seen in 1973, when Synder et al applied the approach to mandibular lengthening in a canine animal model. Almost another 20 years passed before McCarthy and colleagues published, in 1992, the first report of mandibular lengthening in 4 children with congenital mandibular deficiency, 3 with hemifacial microsomia, and 1 with Nager syndrome. Thereafter, its role rapidly expanded to the midface and nearly all classic approaches to craniofacial reconstruction.
In general, mandibular distraction can be performed in the ramus for ramus lengthening, in the mandibular angle for downward and forward advancement, or in the mandibular body. Ramus or gonial angle distraction are mainly used to treat facial asymmetries as in hemifacial macrosomia.
Severe mandibular retrognathia can be classified as congenital or acquired. Congenital abnormalities that are associated with severe mandibular retrognathia or micrognathia include craniofacial syndromes such as hemifacial microsomia, Pierre-Robin syndrome, Treacher-Collins syndrome, and Nager syndrome. Adult patients with craniofacial syndromes may have undergone previous surgery at an earlier age, but unfavorable postsurgical growth or skeletal relapse may have occurred.
Severe mandibular retrognathia also can develop following maxillofacial trauma and mandibular fractures, which may have occurred in an adult or as a child Condylar fractures occurring at an early age can result in subsequent bony and/or fibrous temporomandibular joint ankylosis and/or deficient mandibular growth, also adult patients with complications from previous mandibular tumor resection and reconstruction can also present with acquired severe mandibular retrognathia that may require distraction osteogenesis as well.
Despite the advantages of extra-oral distraction devices in the hands of clinicians (application for very small children, simplicity of attachment, ease of manipulation, bidirectional and multidirectional dis- traction), patients are apprehensive about wearing bulky external appliances because of the social inconvenience and the potential of permanent facial scars, these disadvantages and limitations were the primary force driving the evolution of mandibular lengthening and widening toward the development of intra-oral devices.
However nowadays both internal and external distractors are used in a variety of indications in these cases each of the two types of distractor devices has its own advantages and disadvantages.
Aim of the work:
The aim of this study is to compare external and internal distraction devices for mandibular lengthening in terms of bone lengthening, patient comfort, and complications.
Conditions
- Micrognathia of Lower Jaw
- Retrognathism
- Facial Asymmetry
Interventions
- DEVICE
-
Internal Osteogenesis distractor
Internal distraction osteogenesis in mandible
- DEVICE
-
External Osteogenesis distractor
External distraction osteogenesis in mandible
Sponsors & Collaborators
-
Assiut University
lead OTHER
Principal Investigators
-
Assem Kamel, MD · Assiut University
-
Osama Taha, MD · Assiut University
-
Awny Askalany, MD · Assiut University
-
Ehab Ragab, M.Sc · Assiut University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Month
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2020-05-01
- Completion
- 2020-10-01
More Related Trials
-
Treatment Outcome of Short Implant Assisted Mandibular Overdenture
NCT03540316 ·Status: UNKNOWN ·Phase: NA
-
Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting
NCT04693741 ·Status: UNKNOWN ·Phase: NA
-
Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation
NCT04590339 ·Status: COMPLETED ·Phase: NA
-
Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
NCT05602909 ·Status: UNKNOWN ·Phase: NA
-
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement
NCT05495490 ·Status: RECRUITING ·Phase: NA
-
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony
NCT05340036 ·Status: UNKNOWN ·Phase: NA
-
New Maxillary Expansion Technique in Adults
NCT04908540 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Early Relapse After Mandibular Lengthening Surgery
NCT03710512 ·Status: UNKNOWN
-
Clinical and Radiographic Evaluation of Three Different Modalities for Management of Distal Extension Atrophied Mandibular Ridge: A One Year Prospective Study
NCT05978115 ·Status: UNKNOWN ·Phase: NA
-
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
NCT06500559 ·Status: COMPLETED ·Phase: NA
-
Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible
NCT04133090 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP
NCT06382974 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
NCT05397002 ·Status: COMPLETED ·Phase: NA
-
Computer Guided for Mandibular Distraction Osteogenesis
NCT03869021 ·Status: COMPLETED ·Phase: NA
-
Assessment of Nanocrystalline Hydroxyapatite Versus Autogenous Bone Grafts : A Comparative Clinical Study in Alveolar Cleft Grafting
NCT04693559 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft
NCT06924216 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Association of Force Distribution and Bone Resorption
NCT03026894 ·Status: COMPLETED ·Phase: NA
-
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla
NCT06529653 ·Status: RECRUITING ·Phase: NA
-
Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement
NCT03302143 ·Status: COMPLETED ·Phase: NA
-
Short Implants - An Alternative to Bone Grafting?
NCT01030523 ·Status: COMPLETED ·Phase: NA
-
Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
NCT02753439 ·Status: UNKNOWN ·Phase: NA
-
Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy
NCT06850194 ·Status: RECRUITING ·Phase: NA
-
COMPARATIVE ANALYSIS OF INNOVATIVE BONE HEALING TECHNIQUES
NCT05480631 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone
NCT06388837 ·Status: COMPLETED ·Phase: NA
-
Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute
NCT05305521 ·Status: COMPLETED