ClinicalTrials.gg
CompletedNCT02950727Updated Oct 5, 2021

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

An interventional study of 3 bicortical screws and adjustable plate and 2 bicortical screws in Mandibular Hypoplasia, sponsored by Joseph Van Sickels. Completed. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by Joseph Van Sickels · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2015, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Mandibular Hypoplasia

Browse trials for

Keywords

  • orthognathic surgery
  • bicortical screws
  • monocortical plates
03

In context

Micrognathism

26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.

This study's enrollment of 12 is below the median of 24 across 22 interventional studies indexed under Micrognathism.

Browse Micrognathism studies →

Lead sponsor

This is the only study on the registry with Joseph Van Sickels as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    3 bicortical screw

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

    Device: 3 bicortical screws

  • Active comparator
    adjustable plate and 2 bicortical screws

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

    Device: adjustable plate and 2 bicortical screws

Interventions

  • Device3 bicortical screws

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

  • Deviceadjustable plate and 2 bicortical screws

    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

06

What researchers measure

Primary outcomes

  1. cephalometric analysis to measure angles(degrees)

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

  2. cephalometric analysis to measure lines(mm)

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

Secondary outcomes

  1. operation time in minutes

    Time frame: intraoperative timing during surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2015 to primary completion in Mar 2017, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2016
First posted
Nov 1, 2016
StartActual
Oct 2015
Primary completionActual
Mar 7, 2017
CompletionActual
Mar 7, 2017
Last update
Oct 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02950727
Lead sponsor
Joseph Van Sickels
Responsible party
Joseph Van Sickels (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
Nov 1, 2016
Start date
Oct 2015
Primary completion
Mar 7, 2017
Completion
Mar 7, 2017
Last update
Oct 5, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion