Micrognathia of Lower JawNCT03540329
Comparison Between Internal and External Distractors in Osteogenesis
A study testing Internal Osteogenesis distractor and External Osteogenesis distractor in people with Micrognathia of Lower Jaw and Retrognathism, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 50 years
- Conditions the study is for
- Micrognathia of Lower Jaw, Retrognathism, Facial Asymmetry
- What is being tested?
- Internal Osteogenesis distractor and External Osteogenesis distractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females with congenital retrognathia or micrognathia.
- Males and females between one month and 50 years.
- Patients with acquired mandibular deformities as post traumatic (temporomandibular ankyloses), asymmetries, post-surgical as after mandibular tumor resection and irradiation.
Who cannot join
- 1. Patients with systemic illness as cardiac diseases, or mental disorders \& hepatic patients (generally debilitating diseases).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Internal and External Distraction Osteogenesis in Lower Face Asymmetry
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.
Read more
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.
- Conditions
- Micrognathia of Lower Jaw, Retrognathism, Facial Asymmetry
- Being tested
- Internal Osteogenesis distractor, External Osteogenesis distractor
- Keywords
- osteogenesis, distraction, Lower face asymmetry
- Medical subject headings
- Micrognathism, Retrognathia, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Osteogenesis distractorDevice
Internal distraction osteogenesis in mandible
External Osteogenesis distractorDevice
External distraction osteogenesis in mandible
| Study group | Role | What they receive |
|---|---|---|
| I-A Internal distraction | Active comparator | Internal osteogenesis distractor in congenital mandibular deformities in patients in growing age. Receives: Device: Internal Osteogenesis distractor |
| I-A External distraction | Active comparator | External osteogenesis distractor in congenital mandibular deformities in patients in growing age. Receives: Device: External Osteogenesis distractor |
| I-B Internal distraction | Active comparator | Internal osteogenesis distractor in congenital mandibular deformities in adult patients. Receives: Device: Internal Osteogenesis distractor |
| I-B External distraction | Active comparator | External osteogenesis distractor in congenital mandibular deformities in adult patients. Receives: Device: External Osteogenesis distractor |
| II-A Internal distraction | Active comparator | Internal osteogenesis distractor in acquired mandibular deformities in patients in growing age Receives: Device: Internal Osteogenesis distractor |
| II-A External distraction | Active comparator | External osteogenesis distractor in acquired mandibular deformities in patients in growing age Receives: Device: External Osteogenesis distractor |
| II-B Internal distraction | Active comparator | Internal osteogenesis distractor in acquired mandibular deformities in Adult patients. Receives: Device: Internal Osteogenesis distractor |
| II-B External distraction | Active comparator | External osteogenesis distractor in acquired mandibular deformities in Adult patients. Receives: Device: External Osteogenesis distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bone formation
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Micrognathia of Lower JawStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort prospective study model comparing two different techniques for distraction osteogenesis in 4 different subgroups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Ragab, Assiut University
- Investigators
- Assem Kamel, MD, Principal investigator, Assiut UniversityOsama Taha, MD, Study chair, Assiut UniversityAwny Askalany, MD, Study chair, Assiut UniversityEhab Ragab, M.Sc, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540329
- Sponsor's protocol ID
- Distraction osteogenesis
- Status last verified
- May 2018
- First submitted
- 25 Mar 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 7595803Kaban 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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Internal and External Distraction Osteogenesis in Lower Face Asymmetry
- ClinicalTrials.gov ID
- NCT03540329
- Acronym / sponsor ID
- Distraction osteogenesis
- Conditions
- Micrognathia of Lower Jaw, Retrognathism, Facial Asymmetry
- Keywords
- osteogenesis, distraction, Lower face asymmetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Cohort prospective study model comparing two different techniques for distraction osteogenesis in 4 different subgroups
| Arm | Type | Receives |
|---|---|---|
| I-A Internal distraction | Active comparator | Device: Internal Osteogenesis distractorInternal osteogenesis distractor in congenital mandibular deformities in patients in growing age. |
| I-A External distraction | Active comparator | Device: External Osteogenesis distractorExternal osteogenesis distractor in congenital mandibular deformities in patients in growing age. |
| I-B Internal distraction | Active comparator | Device: Internal Osteogenesis distractorInternal osteogenesis distractor in congenital mandibular deformities in adult patients. |
| I-B External distraction | Active comparator | Device: External Osteogenesis distractorExternal osteogenesis distractor in congenital mandibular deformities in adult patients. |
| II-A Internal distraction | Active comparator | Device: Internal Osteogenesis distractorInternal osteogenesis distractor in acquired mandibular deformities in patients in growing age |
| II-A External distraction | Active comparator | Device: External Osteogenesis distractorExternal osteogenesis distractor in acquired mandibular deformities in patients in growing age |
| II-B Internal distraction | Active comparator | Device: Internal Osteogenesis distractorInternal osteogenesis distractor in acquired mandibular deformities in Adult patients. |
| II-B External distraction | Active comparator | Device: External Osteogenesis distractorExternal osteogenesis distractor in acquired mandibular deformities in Adult patients. |
Who may qualify
- Ages
- 1 month to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males or females with congenital retrognathia or micrognathia.
- Males and females between one month and 50 years.
- Patients with acquired mandibular deformities as post traumatic (temporomandibular ankyloses), asymmetries, post-surgical as after mandibular tumor resection and irradiation.
Key exclusion criteria (1 listed)
- 1. Patients with systemic illness as cardiac diseases, or mental disorders \& hepatic patients (generally debilitating diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Osteogenesis distractorInternal distraction osteogenesis in mandible | Device | I-A Internal distraction, I-B Internal distraction, II-A Internal distraction, II-B Internal distraction |
| External Osteogenesis distractorExternal distraction osteogenesis in mandible | Device | I-A External distraction, I-B External distraction, II-A External distraction, II-B External distraction |
Primary outcome
Rate of bone formation
Time frame: 6 months
2 secondary outcomes
Failure
Time frame: 1 month, 3months, 6months
Complications
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 7595803Rachmiel 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.
- Background: PubMed 9590345Kaban 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assem Kamel, MD principal investigator
Assiut University
Osama Taha, MD study chair
Assiut University
Awny Askalany, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Internal Osteogenesis distractor and External Osteogenesis distractor in people with Micrognathia of Lower Jaw and Retrognathism, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehab Ragab, M.Sc (+201006942649, ehab.m.ragab88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bone formation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.