- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04283981
Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
May 27, 2022 updated by: Timothy C. Woernley III, The University of Texas Health Science Center, Houston
The purpose of this trial is to compare operating room time between conventional treatment techniques (without Virtual surgical Planning (VSP)) versus use of VSP and surgically-guided techniques and to compare and contrast the effect of any other variables that might have an effect on the overall result
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Timothy Woernley, DDS
- Phone Number: (713) 486-4310
- Email: Timothy.C.Woernley@uth.tmc.edu
Study Contact Backup
- Name: Nagi Demian
- Phone Number: (713) 500-7833
- Email: Nagi.Demian@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Nagi Demian
- Phone Number: (713) 500-7833
- Email: Nagi.Demian@uth.tmc.edu
-
Contact:
- Timothy Woernley, DDS
- Phone Number: 713-486-4310
- Email: Timothy.C.Woernley@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient consent
- Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
Exclusion Criteria:
- Patient refusal to participate in study
- Infected mandible fracture
- Closed reduction treatment of mandible fracture
- Fractures older than 2-3 weeks at the time of treatment
- Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures)
- Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection
- Pregnant patients will NOT be excluded from the study
- Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group
|
The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)
|
EXPERIMENTAL: Treatment Group
|
The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time taken to complete an open reduction internal fixation (ORIF)
Time Frame: End of dissection until final screws are placed,about 2-3 hours
|
End of dissection until final screws are placed,about 2-3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with malocclusion
Time Frame: 1 week post surgery
|
1 week post surgery
|
Number of participants with malocclusion
Time Frame: 3 weeks post surgery
|
3 weeks post surgery
|
Number of participants with malocclusion
Time Frame: 6 weeks post surgery
|
6 weeks post surgery
|
Number of participants with fractures that are not well aligned
Time Frame: 1 week post surgery
|
1 week post surgery
|
Number of participants with fractures that are not well aligned
Time Frame: 3 weeks post surgery
|
3 weeks post surgery
|
Number of participants with fractures that are not well aligned
Time Frame: 6 weeks post surgery
|
6 weeks post surgery
|
Number of participants with infections
Time Frame: 1 week post surgery
|
1 week post surgery
|
Number of participants with infections
Time Frame: 3 weeks post surgery
|
3 weeks post surgery
|
Number of participants with infections
Time Frame: 6 weeks post surgery
|
6 weeks post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Timothy Woernley, DDS, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 24, 2021
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
June 1, 2023
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 21, 2020
First Posted (ACTUAL)
February 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-DB-19-1074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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