Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery

NCT06297109 | Active Not Recruiting

• 1 other identifier: S-20230033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire

  Preoperative and two years postoperative

• The Jaw Functional Limitation Scale

  Preoperative and two years postoperative

• The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire

  Preoperative and two years postoperative

• The Epworth Sleepiness Scale questionnaire

  Preoperative and two years postoperative

• The occlusion including horizontal/vertical overlap

  Preoperative, two weeks postoperative and two years postoperative

Study Arms (2)

Intervention

EXPERIMENTAL

Participants treated with patient-specific implants for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery.

Device: Patient-specific implants

Control

ACTIVE COMPARATOR

Participants treated with conventional mini-plates for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery.

Device: Conventional mini-plates

Interventions

Patient-specific implants DEVICE

Application of patient-specific implants for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery.

Intervention

Conventional mini-plates DEVICE

Application of conventional mini-plates for Le Fort I osteotomy and genioplasty in bimaxillary orthognathic surgery.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (1)

University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Retrognathia; Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malocclusion; Tooth Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: March 7, 2024
• Study Start: September 12, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

DK (1)