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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.
Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.
Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.
The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:
Participants will get orthognathic surgery as part of their normal orthodontic treatment.
Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants treated with patient-specific implants for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery. |
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| Control | Active Comparator | Participants treated with conventional mini-plates for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-specific implants | Device | Application of patient-specific implants for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of segmental Le Fort I bone movements | The three-dimensional linear and angular accuracy are measured as differences between the planned and postoperative positions of all repositioned bone segments. Measurements are performed on pre- and two weeks postoperative cone-beam computed tomography scans using the Mimics Innovation Suite software (Materialise NV, Leuven, Belgium). An error measure above 2 mm and/or 4 degrees is categorized as inaccurate. | Two weeks postoperative |
| The stability of segmental Le Fort I bone movements | The three-dimensional linear and angular stability are measured as differences between the short- and long-term postoperative positions of all repositioned bone segments. Measurements are performed on two weeks and two years postoperative cone-beam computed tomography scans using the Mimics Innovation Suite software (Materialise NV, Leuven, Belgium). An error measure above 2 mm and/or 4 degrees is categorized as unstable. | Two years postoperative |
| The stability of the upper airway | The stability of the upper airway space is measured as voluminal and cross-sectional area differences between the short- and long-term postoperative airway in mm3 and mm2, respectively. Measurements are performed on two weeks and two years postoperative cone-beam computed tomography scans using the Mimics Innovation Suite software (Materialise NV, Leuven, Belgium). | Two years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire | Has Yes/No questions for the patient, used by the clinician to diagnose according to specific diagnostic criteria. See: Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A. Diagnostic criteria for temporomandibular disorders (DC/TMD) for clinical and research applications: recommendations of the International RDC/TMD Consortium Network and Orofacial Pain Special Interest Group. Journal of oral & facial pain and headache. 2014;28(1):6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Else M Pinholt, dr.odont. | University Hospital of Southern Denmark, Esbjerg | Study Chair |
| Alexandru Diaconu, m.sc. | University Hospital of Southern Denmark, Esbjerg | Principal Investigator |
| Michael B Holte, ph.d. | University Hospital of Southern Denmark, Esbjerg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Southern Denmark | Esbjerg | 6700 | Denmark |
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| ID | Term |
|---|---|
| D063173 | Retrognathia |
| D008312 | Malocclusion, Angle Class II |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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The care provider and the investigator are blinded up to the selection of the device used for the surgery, as blinding is no longer possible from this state.
| Conventional mini-plates | Device | Application of conventional mini-plates for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery. |
|
| Preoperative and two years postoperative |
| The Jaw Functional Limitation Scale | JFLS-8 measures global functional limitation of the jaw. It has 8 questions scored 0-10, where 10 is the most severe level jaw limitation in the last month. | Preoperative and two years postoperative |
| The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire | It assesses risk/likelihood of obstructive sleep apnea (OSA). It has 8 yes/no questions, and the number of yes answers are counted towards the score as follows: 0-2: low risk of OSA. 3-4: moderate risk of OSA. 5-8: high risk of OSA. | Preoperative and two years postoperative |
| The Epworth Sleepiness Scale questionnaire | Is scored by the sum of the responses to eight questions, on a scale 0-24 where 24 is the highest sleepiness. A score above 10 is considered as significant daytime sleepiness and is considered abnormal. | Preoperative and two years postoperative |
| The occlusion including horizontal/vertical overlap | The horizontal/vertical dental overlap is measured using a ruler in millimeters. | Preoperative, two weeks postoperative and two years postoperative |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |