An interventional study of Internal Osteogenesis distractor and External Osteogenesis distractor in Micrognathia of Lower Jaw, Retrognathism and Facial Asymmetry, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 50 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
The study will be conducted on 30 patients who are suffering mandibular problems either congenital acquired or post tumor mandibular resection that requires lengthening of the mandible, attending the outpatient clinic of Plastic Surgery Department in Ain Shams University Hospital \& Assiut University Hospital.
Preoperative assessment:
Principles of the operation:
Postoperative management and assessment:
26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 22 interventional studies indexed under Micrognathism.
Browse Micrognathism studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Internal osteogenesis distractor in congenital mandibular deformities in patients in growing age.
Device: Internal Osteogenesis distractor
External osteogenesis distractor in congenital mandibular deformities in patients in growing age.
Device: External Osteogenesis distractor
Internal osteogenesis distractor in congenital mandibular deformities in adult patients.
Device: Internal Osteogenesis distractor
External osteogenesis distractor in congenital mandibular deformities in adult patients.
Device: External Osteogenesis distractor
Internal osteogenesis distractor in acquired mandibular deformities in patients in growing age
Device: Internal Osteogenesis distractor
External osteogenesis distractor in acquired mandibular deformities in patients in growing age
Device: External Osteogenesis distractor
Internal osteogenesis distractor in acquired mandibular deformities in Adult patients.
Device: Internal Osteogenesis distractor
External osteogenesis distractor in acquired mandibular deformities in Adult patients.
Device: External Osteogenesis distractor
Internal distraction osteogenesis in mandible
External distraction osteogenesis in mandible
Rate of bone formation
Time frame: 6 months
Failure
Failure of distraction will be assessed by the amount of bone formed in mm and the target rate of bone lenghtening to be achieved... e.g.. if the target is to lengthen 20mm we consider failure if the bone lengthening is less than 20mm
Time frame: 1 month, 3months, 6months
Complications
infection will be assessed for discharge around the pins if fever is present after operation this will be considered as infection from surgery, post-operative scars wether the scar is depressed hypertrophic or keloid forming scar, loosening of the pins wehter they remained in place or otherwise they are loosened
Time frame: 1 week
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2018; primary completion for May 2020, 21 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.