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
About this trial
This is an interventional treatment trial for Mandibular Hypoplasia focused on measuring orthognathic surgery, bicortical screws, monocortical plates
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
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
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
Learn more about this trial
Comparing Stability and Cost-Effectiveness of 3 Bicortical Screws Vs Adjustable Plate and 2 Bicortical Screws in Fixation of BSSRO
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