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NCT Number: NCT06297109

Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Retrognathia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Malocclusion Malocclusion, Angle Class II Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-specific implants

Device

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

Conventional mini-plates

Device

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

Primary outcomes

  1. The accuracy of segmental Le Fort I bone movements

    Time frame: Two weeks postoperative

    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.

  2. The stability of segmental Le Fort I bone movements

    Time frame: Two years postoperative

    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.

  3. The stability of the upper airway

    Time frame: Two years postoperative

    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).

Secondary outcomes

  1. The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire

    Time frame: Preoperative and two years postoperative

    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.

  2. The Jaw Functional Limitation Scale

    Time frame: Preoperative and two years postoperative

    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.

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

    Time frame: Preoperative and two years postoperative

    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.

  4. The Epworth Sleepiness Scale questionnaire

    Time frame: Preoperative and two years postoperative

    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.

  5. The occlusion including horizontal/vertical overlap

    Time frame: Preoperative, two weeks postoperative and two years postoperative

    The horizontal/vertical dental overlap is measured using a ruler in millimeters.

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery: A Quality Assessment by Novel Automated Virtual Methods

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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