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Mandibular HypoplasiaNCT02950727

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

A study testing 3 bicortical screws and adjustable plate and 2 bicortical screws in people with Mandibular Hypoplasia, run by Joseph Van Sickels.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mandibular Hypoplasia
What is being tested?
3 bicortical screws and adjustable plate and 2 bicortical screws
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Oct 2015to 7 Mar 2017
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
3 bicortical screws, adjustable plate and 2 bicortical screws
Keywords
orthognathic surgery, bicortical screws, monocortical plates
Medical subject headings
Micrognathism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 bicortical screwsDevice

    after mandibular bilateral sagittal split ramus osteotomy surgery is performed in the first group the osteotomy will be fixed using 3 bicortical screws

  • adjustable plate and 2 bicortical screwsDevice

    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

Study groups in NCT02950727
Study groupRoleWhat they receive
3 bicortical screwExperimental1st group:3 bicortical screws will be used to fix the sagittal split ramus osteotomy.
Receives: Device: 3 bicortical screws
adjustable plate and 2 bicortical screwsActive comparatoradjustable plate and 2 bicortical screws will be used to fix the sagittal split ramus osteotomy.
Receives: Device: adjustable plate and 2 bicortical screws

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cephalometric analysis to measure angles(degrees)

    Measured: (an xray preoperative, immediate postoperative, 6 weeks and 6 months)

  2. cephalometric analysis to measure lines(mm)

    Measured: (an xray preoperative, immediate postoperative, 6 weeks and 6 months)

Secondary outcomes (1)
  1. operation time in minutes

    Measured: intraoperative timing during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study startOct 2015
  3. Primary completion7 Mar 2017
  4. Study completion7 Mar 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02950727
Sponsor's protocol ID
15-0769-F3R
Status last verified
Sep 2021
First submitted
23 Aug 2016
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16243179
  • 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.

    PubMed 10371309
  • 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.

    PubMed 16122596

Questions about this trial

What is this clinical trial studying?

A study testing 3 bicortical screws and adjustable plate and 2 bicortical screws in people with Mandibular Hypoplasia, run by Joseph Van Sickels.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Oct 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cephalometric analysis to measure angles(degrees) (time frame: (an xray preoperative, immediate postoperative, 6 weeks and 6 months)). The study lists 2 primary outcomes in all. 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 NCT02950727, which also lists 3 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 5 Oct 2021.

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