Back to resultsThe Use of Bone-borne Guides in Orthognathic Surgery Cases
Primary Purpose
Dentofacial Deformities
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bone-borne CAD/CAM splint
3D interocclusal conventional splint
Sponsored by
About this trial
This is an interventional treatment trial for Dentofacial Deformities focused on measuring Le Fort, Orthognathic surgery, Virtual surgical planning
Eligibility Criteria
Inclusion Criteria:
- Patients with dentofacial deformity requiring Le Fort I osteotomy
Exclusion Criteria:
- Patients with severe asymmetry
Sites / Locations
- Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Study
Arm Description
Interocclusal conventional splint is used to reposition the maxilla.
Bone-borne splint is used to reposition the maxilla.
Outcomes
Primary Outcome Measures
Error of superimposition
Superimposition error between planned and actual maxillary position
Secondary Outcome Measures
Visual Analogue Scale
Pain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.
Procedure duration
Time of the surgery using the splint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04224805
Brief Title
The Use of Bone-borne Guides in Orthognathic Surgery Cases
Official Title
Evaluation of the Use of Bone-borne CAD/CAM Surgical Guides in Orthognathic Surgery Cases Requiring Le Fort I Osteotomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
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
The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.
Detailed Description
Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentofacial Deformities
Keywords
Le Fort, Orthognathic surgery, Virtual surgical planning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Interocclusal conventional splint is used to reposition the maxilla.
Arm Title
Study
Arm Type
Experimental
Arm Description
Bone-borne splint is used to reposition the maxilla.
Intervention Type
Device
Intervention Name(s)
Bone-borne CAD/CAM splint
Intervention Description
3D printed splint that repositions the maxilla with the zygomatic buttress as a reference.
Intervention Type
Device
Intervention Name(s)
3D interocclusal conventional splint
Intervention Description
Interocclusal splint that relies on the centric relation of the condyle as well as occlusion.
Primary Outcome Measure Information:
Title
Error of superimposition
Description
Superimposition error between planned and actual maxillary position
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Pain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.
Time Frame
3 months
Title
Procedure duration
Description
Time of the surgery using the splint
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with dentofacial deformity requiring Le Fort I osteotomy
Exclusion Criteria:
Patients with severe asymmetry
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
22111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Use of Bone-borne Guides in Orthognathic Surgery Cases
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