Orthognathic Surgery Clinical Trial
Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are
becoming state of the art in orthognathic surgery. However, current available software is
still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the
preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning
software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).
Objectives The investigators aim to test pre-release versions of the IPSCD software under
real-world working conditions in strictly selected university, general and private hospital
settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant
reduction in treatment planning time.
Study design closed beta-phase; international, multi-centric, prospective study Patients
presenting at the division of maxillofacial surgery at the different hospital centers, for an
orthognathic-related problem will receive a complete routine work-up, including a cone-beam
CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all
the virtual planning steps with the novel software. Timing of the eight major steps will be
measured with a digital chronometer.
One hundred and eight patient cases will be planned with the IPSCD software in the
participating centers over a period of three months, in the order of respectively one, three
and five cases per month per participating center.
Investigators will register anonymized patient demographics (age, gender, clinical diagnosis,
type of surgery), and provide feedback regarding the required time to complete the different
surgical planning steps, regarding the number of failed alignments, and the occurrence of
software bugs. Intergroup comparison of virtual planning time between the different centers
will be analyzed. In addition, the learning effect will be examined through comparison of the
different cases planned by the same surgeon and/or orthodontist, or in comparison to the
initial beta-testing phase results by GS.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05536596 -
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT03318757 -
Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery
|
Phase 4 | |
| Not yet recruiting |
NCT03486951 -
Outpatient Orthognathic Surgery: "AMBOST" a One Year Study
|
||
| Recruiting |
NCT05009056 -
Functional Appliance for Orthognathic Surgery
|
N/A | |
| Recruiting |
NCT01989715 -
Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.
|
N/A | |
| Completed |
NCT01461031 -
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
|
N/A | |
| Completed |
NCT03986723 -
3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
|
||
| Completed |
NCT05316545 -
Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery
|
||
| Completed |
NCT06233188 -
Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture
|
N/A | |
| Not yet recruiting |
NCT06093893 -
Hypotensive Anesthesia for Orthognathic Surgery
|
Phase 4 | |
| Not yet recruiting |
NCT06338982 -
Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars
|
N/A | |
| Completed |
NCT06188403 -
Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery
|
N/A | |
| Active, not recruiting |
NCT06400355 -
Effect of Mannitol on Recovery Pattern After Orthognathic Surgery
|
N/A | |
| Completed |
NCT06301204 -
Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients
|
N/A | |
| Not yet recruiting |
NCT04353635 -
Prediction Accuracy of Dolphin 3D in Bimax Surgery for Class III
|
||
| Withdrawn |
NCT03433144 -
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
|
Phase 4 | |
| Completed |
NCT06103422 -
Change in Taste Sensation After Orthognathic Surgery
|
N/A | |
| Suspended |
NCT04910074 -
LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery
|
N/A | |
| Recruiting |
NCT05717322 -
TENS and Orthognathic Surgery
|
N/A | |
| Completed |
NCT05184725 -
CARINAE for Stress Relief in Perioperative Care
|
N/A |