NCT02950727

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

August 23, 2016

Last Update Submit

September 27, 2021

Conditions

Mandibular Hypoplasia

Keywords

orthognathic surgerybicortical screwsmonocortical plates

Outcome Measures

Primary Outcomes (2)

  • cephalometric analysis to measure angles(degrees)

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

  • cephalometric analysis to measure lines(mm)

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

Secondary Outcomes (1)

  • operation time in minutes

    intraoperative timing during surgery

Study Arms (2)

3 bicortical screw

EXPERIMENTAL

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

Device: 3 bicortical screws

adjustable plate and 2 bicortical screws

ACTIVE COMPARATOR

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

Device: adjustable plate and 2 bicortical screws

Interventions

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

3 bicortical screw
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

adjustable plate and 2 bicortical screws

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 16243179BACKGROUND

  • 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.

    PMID: 10371309RESULT

  • 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.

    PMID: 16122596RESULT

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2016

First Posted

November 1, 2016

Study Start

October 1, 2015

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

October 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share