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Comparing Stability and Cost-Effectiveness of 3 Bicortical Screws Vs Adjustable Plate and 2 Bicortical Screws in Fixation of BSSRO

Primary Purpose

Mandibular Hypoplasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3 bicortical screws
adjustable plate and 2 bicortical screws
Sponsored by
Joseph Van Sickels
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Hypoplasia focused on measuring orthognathic surgery, bicortical screws, monocortical plates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients suffering from mandibular retrognathia (anteroposterior deficient mandible)
  • Patients should be free from any systemic disease that may affect normal healing, and predictable outcome

Exclusion Criteria:

  • Patients with any systemic disease that may affect normal healing
  • Intra-bony lesions or infections that may retard the osteotomy healing
  • Uncooperative Patient with bad oral hygiene

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    3 bicortical screw

    adjustable plate and 2 bicortical screws

    Arm Description

    1st group:3 bicortical screws will be used to fix the sagittal split ramus osteotomy.

    adjustable plate and 2 bicortical screws will be used to fix the sagittal split ramus osteotomy.

    Outcomes

    Primary Outcome Measures

    cephalometric analysis to measure angles(degrees)
    cephalometric analysis to measure lines(mm)

    Secondary Outcome Measures

    operation time in minutes

    Full Information

    First Posted
    August 23, 2016
    Last Updated
    September 27, 2021
    Sponsor
    Joseph Van Sickels
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02950727
    Brief Title
    Comparing Stability and Cost-Effectiveness of 3 Bicortical Screws Vs Adjustable Plate and 2 Bicortical Screws in Fixation of BSSRO
    Official Title
    Stability of Bilateral Sagittal Split Ramus Osteotomy (BSSRO) Using Adjustable Mandibular Plates in Adjunction With Bicortical Screws Versus Traditional Positional Screws for Antero-posterior Mandibular Deficient Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    March 7, 2017 (Actual)
    Study Completion Date
    March 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joseph Van Sickels

    4. Oversight

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

    5. Study Description

    Brief Summary
    In this current study a comparison between 3 positional screws versus the adjustable plating system in conjunction with 2 positional screws. The patients will be selected to have retrognathic mandible requiring advancement. Hypothetically the advantage of the adjustable plating system will be compared with the three positional screws. In theory, the investigators will be using the inherent advantage of the intraoperative flexibility of the adjustable plating system in verifying the position of the proximal segment (condylar segment), hence eliminating the immediate postoperative relapse that is reported with using three positional screws. This will be evaluated both clinically and cephalometrically.
    Detailed Description
    Trauner and Obwegeser in 1957, reported the first correction of jaw deformity by the sagittal split technique. Dal Pont in 1961, a student of Obwegeser, made a modification to the latter technique, to further enhance the precision and the accuracy of movement of both proximal distal segments his technique has become widely publicized. He changed the lower horizontal cut to a vertical cut on the buccal cortex between the first and second molars, there by obtaining broader bony contact. Hunsuck in 1968, modified the technique, to decrease the soft tissue dissection; he advocated a shorter horizontal medial cut. Epker in 1977, modified the technique in several ways to decrease swelling, manipulation to the neurovascular bundle and hemorrhage, his modification included minimal stripping of the masseter muscle and medial dissection. BSSRO is now the most common procedure used to advance the mandible is a bilateral sagittal split osteotomy. There are many different methods of mandibular fixation such as using intra osseous wiring combined with inter maxillary fixation (IMF) which showed significant amount of relapse and patient dissatisfaction, this is called nonrigid fixation. Another type of mandibular fixation is the three point fixation using positioning screws called rigid fixation. Rigid internal fixation was introduced in 1976 by Spiessel to promote healing, restore early function, and decrease relapse. The introduction of an internal rigid fixation method, instead of 5-6 week intermaxillary fixation, had the added benefit of shorter periods of hospital stay and patient convenience.' Minimal or no immobilization of the jaws allows patients to function sooner, resume their daily activities, and return to work earlier. In a relatively short period of time, the use of rigid fixation of bony segments in orthognathic surgery had become a standard of care. A major concern in the surgical correction of a anteroposterior mandibular deficient patients is potential postsurgical relapse. Clinical studies have shown a wide array of successful techniques used to fix segments. Three bicortical screws placed in an inverted-L fashion has become the gold standard for stabilizing a bilateral sagittal split advancement. Various problems emerged, however, showing that the stability necessary for the stabilization of an osteotomy site cannot be directly compared with that of a fracture. Other problems encountered were difficulties in positioning the fragments in new sites, which resulted in malposition of the condyle. This led to the term 'immediate postoperative relapse'. In addition, pain and dysfunction of the temporomandibular joint (TMJ) complicated the treatment and made the target of long-term stability difficult to achieve. In this current study a comparison between 3 positional screws in comparison with the adjustable plate in conjunction with 2 positional screws will be used in a group of patients suffering from retrognathia and will be treated by BSSRO, thus the investigators are using the advantage of the inherent adjustability of the plate intraoperatively with the good fixation and the stability inherent in the bicortical screws short term stability. This will be evaluated both clinically and cephalometrically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandibular Hypoplasia
    Keywords
    orthognathic surgery, bicortical screws, monocortical plates

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3 bicortical screw
    Arm Type
    Experimental
    Arm Description
    1st group:3 bicortical screws will be used to fix the sagittal split ramus osteotomy.
    Arm Title
    adjustable plate and 2 bicortical screws
    Arm Type
    Active Comparator
    Arm Description
    adjustable plate and 2 bicortical screws will be used to fix the sagittal split ramus osteotomy.
    Intervention Type
    Device
    Intervention Name(s)
    3 bicortical screws
    Intervention Description
    after mandibular bilateral sagittal split ramus osteotomy surgery is performed in the first group the osteotomy will be fixed using 3 bicortical screws
    Intervention Type
    Device
    Intervention Name(s)
    adjustable plate and 2 bicortical screws
    Intervention Description
    after mandibular bilateral sagittal split ramus osteotomy surgery is performed in the second group the osteotomy will be fixed using adjustable plate and 2 bicortical screws
    Primary Outcome Measure Information:
    Title
    cephalometric analysis to measure angles(degrees)
    Time Frame
    (an xray preoperative, immediate postoperative, 6 weeks and 6 months)
    Title
    cephalometric analysis to measure lines(mm)
    Time Frame
    (an xray preoperative, immediate postoperative, 6 weeks and 6 months)
    Secondary Outcome Measure Information:
    Title
    operation time in minutes
    Time Frame
    intraoperative timing during surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from mandibular retrognathia (anteroposterior deficient mandible) Patients should be free from any systemic disease that may affect normal healing, and predictable outcome Exclusion Criteria: Patients with any systemic disease that may affect normal healing Intra-bony lesions or infections that may retard the osteotomy healing Uncooperative Patient with bad oral hygiene

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16243179
    Citation
    Van Sickels JE, Peterson GP, Holms S, Haug RH. An in vitro comparison of an adjustable bone fixation system. J Oral Maxillofac Surg. 2005 Nov;63(11):1620-5. doi: 10.1016/j.joms.2005.06.008.
    Results Reference
    background
    PubMed Identifier
    10371309
    Citation
    Joos U. An adjustable bone fixation system for sagittal split ramus osteotomy: preliminary report. Br J Oral Maxillofac Surg. 1999 Apr;37(2):99-103. doi: 10.1054/bjom.1997.0081.
    Results Reference
    result
    PubMed Identifier
    16122596
    Citation
    Peterson GP, Haug RH, Van Sickels J. A biomechanical evaluation of bilateral sagittal ramus osteotomy fixation techniques. J Oral Maxillofac Surg. 2005 Sep;63(9):1317-24. doi: 10.1016/j.joms.2005.05.301.
    Results Reference
    result

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    Comparing Stability and Cost-Effectiveness of 3 Bicortical Screws Vs Adjustable Plate and 2 Bicortical Screws in Fixation of BSSRO

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