Accuracy of Maxillary Repositioning During Orthognathic Surgery

NCT03357211 | Completed

• 1 other identifier: 2016-01-POMOCOBS
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.

Conditions

Orthognathic Surgery; Maxillofacial Abnormalities

Outcome Measures

Primary Outcomes (1)

• Distribution of the translational and rotational shifts of the maxilla between planning and realization

  Shifts will be quantified by 6 components (3 in rotation and 3 in translation) in a coordinate system given by Orthopilot™ navigation system. Accuracy of the surgical technic is evaluated by the distribution of the translational and rotational shifts of the maxilla between planning and realization, taking account conformity (when left/right translation is ≤ 1 mm, top/bottom and back/front translations are \< 2 mm, frontal rotation is ≤ 1° and axial and sagittal rotations are ≤ 2°), failure (when left/right, top/bottom and back/front translations are \> 2 mm, frontal, axial and sagittal rotations are \>4°), and non conformity (every other shifts).

  during the surgery

Secondary Outcomes (1)

• Inter-incisal vector

  during the surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients needing orthognathic surgery with monobloc mobilization of the maxilla via a Le Fort I osteotomy alone or associated to a mandibular osteotomy, whatever the indication (malocclusion, sleep apnea, temporomandibular dysfunction...), who are adressed to the principal investigator

You may qualify if:

• patients needing orthognathic surgery with mobilization of the maxilla via a Le Fort I osteotomy, alone or associated to a mandibular osteotomy, whatever the indication (poor occlusion, sleep apnea, temporo-mandibular dysfunction...)
• patient over 16 years old
• having not expressed any opposition to the collection of his/her personal data for this study (patient him/herself or holder of parental authority in case of patients younger than 18)

You may not qualify if:

• pregnancy
• patients deprived of liberty
• protected adult
• patients needing maxillary disjunction

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

MeSH Terms

Conditions

Maxillofacial Abnormalities

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Georges Bettega, MD/PhD

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 29, 2017
• Study Start: February 29, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11