Comparison Between Internal and External Distractors in Osteogenesis

NCT03540329 | Unknown

• 1 other identifier: Distraction osteogenesis
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Micrognathia of Lower Jaw; Retrognathism; Facial Asymmetry

Keywords

osteogenesis; distraction; Lower face asymmetry

Outcome Measures

Primary Outcomes (1)

• Rate of bone formation

  6 months

Secondary Outcomes (2)

• Failure

  1 month, 3months, 6months

• Complications

  1 week

Study Arms (8)

I-A Internal distraction

ACTIVE COMPARATOR

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

Device: Internal Osteogenesis distractor

I-A External distraction

ACTIVE COMPARATOR

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

Device: External Osteogenesis distractor

I-B Internal distraction

ACTIVE COMPARATOR

Internal osteogenesis distractor in congenital mandibular deformities in adult patients.

Device: Internal Osteogenesis distractor

I-B External distraction

ACTIVE COMPARATOR

External osteogenesis distractor in congenital mandibular deformities in adult patients.

Device: External Osteogenesis distractor

II-A Internal distraction

ACTIVE COMPARATOR

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

Device: Internal Osteogenesis distractor

II-A External distraction

ACTIVE COMPARATOR

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

Device: External Osteogenesis distractor

II-B Internal distraction

ACTIVE COMPARATOR

Internal osteogenesis distractor in acquired mandibular deformities in Adult patients.

Device: Internal Osteogenesis distractor

II-B External distraction

ACTIVE COMPARATOR

External osteogenesis distractor in acquired mandibular deformities in Adult patients.

Device: External Osteogenesis distractor

Interventions

Internal Osteogenesis distractor DEVICE

Internal distraction osteogenesis in mandible

I-A Internal distraction; I-B Internal distraction; II-A Internal distraction; II-B Internal distraction

External Osteogenesis distractor DEVICE

External distraction osteogenesis in mandible

I-A External distraction; I-B External distraction; II-A External distraction; II-B External distraction

Eligibility Criteria

• Age: 1 Month - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 7595803 BACKGROUND

• 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.

  PMID: 9590345 BACKGROUND

MeSH Terms

Conditions

Micrognathism; Retrognathia; Facial Asymmetry

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mandibular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Assem Kamel, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Osama Taha, MD

  Assiut University

  STUDY CHAIR

• Awny Askalany, MD

  Assiut University

  STUDY CHAIR

• Ehab Ragab, M.Sc

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ehab Ragab, M.Sc

CONTACT

+201006942649; ehab.m.ragab88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Cohort prospective study model comparing two different techniques for distraction osteogenesis in 4 different subgroups

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: May 30, 2018
• Study Start: August 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 30, 2018

Record last verified: 2018-05