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Comparison Between Internal and External Distractors in Osteogenesis

Primary Purpose

Micrognathia of Lower Jaw, Retrognathism, Facial Asymmetry

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internal Osteogenesis distractor
External Osteogenesis distractor
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Micrognathia of Lower Jaw focused on measuring osteogenesis, distraction, Lower face asymmetry

Eligibility Criteria

1 Month - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    I-A Internal distraction

    I-A External distraction

    I-B Internal distraction

    I-B External distraction

    II-A Internal distraction

    II-A External distraction

    II-B Internal distraction

    II-B External distraction

    Arm Description

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

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

    Internal osteogenesis distractor in congenital mandibular deformities in adult patients.

    External osteogenesis distractor in congenital mandibular deformities in adult patients.

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

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

    Internal osteogenesis distractor in acquired mandibular deformities in Adult patients.

    External osteogenesis distractor in acquired mandibular deformities in Adult patients.

    Outcomes

    Primary Outcome Measures

    Rate of bone formation

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    March 25, 2018
    Last Updated
    May 28, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03540329
    Brief Title
    Comparison Between Internal and External Distractors in Osteogenesis
    Official Title
    Comparative Study Between Internal and External Distraction Osteogenesis in Lower Face Asymmetry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    May 1, 2020 (Anticipated)
    Study Completion Date
    October 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Micrognathia of Lower Jaw, Retrognathism, Facial Asymmetry
    Keywords
    osteogenesis, distraction, Lower face asymmetry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cohort prospective study model comparing two different techniques for distraction osteogenesis in 4 different subgroups
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    I-A Internal distraction
    Arm Type
    Active Comparator
    Arm Description
    Internal osteogenesis distractor in congenital mandibular deformities in patients in growing age.
    Arm Title
    I-A External distraction
    Arm Type
    Active Comparator
    Arm Description
    External osteogenesis distractor in congenital mandibular deformities in patients in growing age.
    Arm Title
    I-B Internal distraction
    Arm Type
    Active Comparator
    Arm Description
    Internal osteogenesis distractor in congenital mandibular deformities in adult patients.
    Arm Title
    I-B External distraction
    Arm Type
    Active Comparator
    Arm Description
    External osteogenesis distractor in congenital mandibular deformities in adult patients.
    Arm Title
    II-A Internal distraction
    Arm Type
    Active Comparator
    Arm Description
    Internal osteogenesis distractor in acquired mandibular deformities in patients in growing age
    Arm Title
    II-A External distraction
    Arm Type
    Active Comparator
    Arm Description
    External osteogenesis distractor in acquired mandibular deformities in patients in growing age
    Arm Title
    II-B Internal distraction
    Arm Type
    Active Comparator
    Arm Description
    Internal osteogenesis distractor in acquired mandibular deformities in Adult patients.
    Arm Title
    II-B External distraction
    Arm Type
    Active Comparator
    Arm Description
    External osteogenesis distractor in acquired mandibular deformities in Adult patients.
    Intervention Type
    Device
    Intervention Name(s)
    Internal Osteogenesis distractor
    Intervention Description
    Internal distraction osteogenesis in mandible
    Intervention Type
    Device
    Intervention Name(s)
    External Osteogenesis distractor
    Intervention Description
    External distraction osteogenesis in mandible
    Primary Outcome Measure Information:
    Title
    Rate of bone formation
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Failure
    Description
    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
    Title
    Complications
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 1. Patients with systemic illness as cardiac diseases, or mental disorders & hepatic patients (generally debilitating diseases).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ehab Ragab, M.Sc
    Phone
    +201006942649
    Email
    ehab.m.ragab88@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Assem Kamel, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Osama Taha, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Awny Askalany, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ehab Ragab, M.Sc
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    7595803
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9590345
    Citation
    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.
    Results Reference
    background

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    Comparison Between Internal and External Distractors in Osteogenesis

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