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Status unknownNCT03540329Updated May 30, 2018

Comparison Between Internal and External Distractors in Osteogenesis

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

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
1 Month to 50 Years
Sex
All
01

Study 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.

Read the detailed description

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:

  • Informed consent will be obtained from all patients before their inclusion in the study.
  • Photographs will be taken for the patient in lateral, antro-posterior and oblique positions preoperative.
  • Lateral cephalometric radiographs or computed tomography (CT) or cone beam CT scans will be done for each patient pre-operatively.
  • The decision to perform internal or external device will be based on preoperative and intraoperative considerations, such as anatomical bony characteristics affecting the possibility to place internal devices and patient cooperation.

Principles of the operation:

  • anaesthesia: general anesthesia.
  • Intraoperative consideration of internal versus external distractor is decided depending on the availability of bone stock.
  • Osteotomy will be done according to each case individually making sure that it suits the vector of distraction required for each case.
  • The approach for the external devices will be intraoral between the mental nerve anteriorly and gonial area posteriorly on both sides of the mandible.
  • The approach for internal devices will be intraoral. While preserving the mandibular branch of the facial nerve.
  • After 3-5 days of latency period for callus organization, gradual lengthening of the mandible will be performed at a rate of 0.5 mm twice a day for a total of 1 mm per day until achieving desired length.

Postoperative management and assessment:

  • The patient will take broad spectrum and anaerobic antibiotics, anti-edematous, analgesic in addition to supportive treatment.
  • After 3-5 days of latency period for callus organization according to patient age and condition, gradual lengthening of the mandible was performed at a rate of 0.5 mm twice a day for a total of 1 mm per day until achieving desired length.
  • Following distraction phase there will be consolidation phase that will not be less than 8 weeks.
  • Removing of internal or external distractor device and start retention phase if required with assistance of orthodontic appliances to avoid relapse.
  • The patients will be evaluated with lateral cephalograms and head CT to assess the changes and amount of new bone formation following distraction.
02

Conditions studied

  • Micrognathia of Lower Jaw
  • Retrognathism
  • Facial Asymmetry

Keywords

  • osteogenesis
  • distraction
  • Lower face asymmetry
03

In context

Micrognathism

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
1 Month to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Males or females with congenital retrognathia or micrognathia.
  2. Males and females between one month and 50 years.
  3. Patients with acquired mandibular deformities as post traumatic (temporomandibular ankyloses), asymmetries, post-surgical as after mandibular tumor resection and irradiation.

Exclusion criteria

Exclusion Criteria:

  1. Patients with systemic illness as cardiac diseases, or mental disorders \& hepatic patients (generally debilitating diseases).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    I-A Internal distraction

    Internal osteogenesis distractor in congenital mandibular deformities in patients in growing age.

    Device: Internal Osteogenesis distractor

  • Active comparator
    I-A External distraction

    External osteogenesis distractor in congenital mandibular deformities in patients in growing age.

    Device: External Osteogenesis distractor

  • Active comparator
    I-B Internal distraction

    Internal osteogenesis distractor in congenital mandibular deformities in adult patients.

    Device: Internal Osteogenesis distractor

  • Active comparator
    I-B External distraction

    External osteogenesis distractor in congenital mandibular deformities in adult patients.

    Device: External Osteogenesis distractor

  • Active comparator
    II-A Internal distraction

    Internal osteogenesis distractor in acquired mandibular deformities in patients in growing age

    Device: Internal Osteogenesis distractor

  • Active comparator
    II-A External distraction

    External osteogenesis distractor in acquired mandibular deformities in patients in growing age

    Device: External Osteogenesis distractor

  • Active comparator
    II-B Internal distraction

    Internal osteogenesis distractor in acquired mandibular deformities in Adult patients.

    Device: Internal Osteogenesis distractor

  • Active comparator
    II-B External distraction

    External osteogenesis distractor in acquired mandibular deformities in Adult patients.

    Device: External Osteogenesis distractor

Interventions

  • DeviceInternal Osteogenesis distractor

    Internal distraction osteogenesis in mandible

  • DeviceExternal Osteogenesis distractor

    External distraction osteogenesis in mandible

06

What researchers measure

Primary outcomes

  1. Rate of bone formation

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rachmiel A, Levy M, Laufer D. Lengthening of the mandible by distraction osteogenesis: report of cases. J Oral Maxillofac Surg. 1995 Jul;53(7):838-46. doi: 10.1016/0278-2391(95)90346-1. No abstract available. PubMed 7595803 ↗
  • Kaban LB, Padwa BL, Mulliken JB. Surgical correction of mandibular hypoplasia in hemifacial microsomia: the case for treatment in early childhood. J Oral Maxillofac Surg. 1998 May;56(5):628-38. doi: 10.1016/s0278-2391(98)90465-7. No abstract available. PubMed 9590345 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Mar 25, 2018
First posted
May 30, 2018
StartEst.
Aug 1, 2018
Primary completionEst.
May 1, 2020
CompletionEst.
Oct 1, 2020
Last update
May 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03540329
Lead sponsor
Assiut University
Responsible party
Ehab Ragab (Assistant Lecturer, Assiut University) — Principal investigator
First posted
May 30, 2018
Start date
Aug 1, 2018 (estimated)
Primary completion
May 1, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
May 30, 2018

Study contacts

Ehab Ragab, M.Sc
Contact
ehab.m.ragab88@gmail.com
+201006942649
Assem Kamel, MD
principal investigator · Assiut University
Osama Taha, MD
study chair · Assiut University
Awny Askalany, MD
study chair · Assiut University
Ehab Ragab, M.Sc
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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