Clinical trial NCT06297109: Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery
Official title: Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery: A Quality Assessment by Novel Automated Virtual Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retrognathia
Malocclusion, Angle Class II
Keywords: Orthognathic Surgery
Computer-Assisted Surgery
Three-dimensional Imaging
Cone-Beam Computed Tomography
Virtual Surgical Planning
Maxillary Osteotomy
Mandibular Osteotomy
Genioplasty
Osteotomy, Le Fort
Patient-Specific Implants
Accuracy
Stability
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2024-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* Does using PSIs provide accurate movements of the maxilla pieces?
* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
* Does using PSIs provide stable movements of the maxilla pieces after 2 years?
* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?

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.


Eligibility criteria: Inclusion Criteria:

* Mandibular retrognathia
* Occlusion class II
* Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty

Exclusion Criteria:

* Cleft lip
* Craniofacial syndromes
* Former trauma
* Obstructive sleep apnea

Primary outcomes:
measure: The accuracy of segmental Le Fort I bone movements
timeFrame: Two weeks postoperative
measure: The stability of segmental Le Fort I bone movements
timeFrame: Two years postoperative
measure: The stability of the upper airway
timeFrame: Two years postoperative
Secondary outcomes:
measure: The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire
timeFrame: Preoperative and two years postoperative
measure: The Jaw Functional Limitation Scale
timeFrame: Preoperative and two years postoperative
measure: The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire
timeFrame: Preoperative and two years postoperative
measure: The Epworth Sleepiness Scale questionnaire
timeFrame: Preoperative and two years postoperative
measure: The occlusion including horizontal/vertical overlap
timeFrame: Preoperative, two weeks postoperative and two years postoperative
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: University Hospital of Southern Denmark
Study officials:
affiliation: University Hospital of Southern Denmark, Esbjerg
name: Else M Pinholt, dr.odont.
role: STUDY_CHAIR
affiliation: University Hospital of Southern Denmark, Esbjerg
name: Alexandru Diaconu, m.sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Southern Denmark, Esbjerg
name: Michael B Holte, ph.d.
role: STUDY_DIRECTOR
References: