Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea
1 other identifier
interventional
80
1 country
1
Brief Summary
ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period:
- Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1).
- Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery.
- Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist)
- Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12).
- Record of body mass index (BMI) (cm/Kg2) Main Objective:
- Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives:
- Interrelate the degree of dentofacial deformity with the IAH.
- Study the potential correlation between the volume of the VAS and the IAH.
- Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS).
- Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA.
- To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA.
- Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA.
- Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term.
- Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis
- H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term.
- H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2018
CompletedFirst Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 16, 2023
May 1, 2023
5.7 years
January 3, 2019
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Upper airway volume change
Evaluation of volume change of the pharyngeal airway before (Day 0) and month (Month 1) and 12 months (Month 12) comparing the three-dimensional measurements of maxillary /bimaxillary surgery by conical beam computed tomography superposition. Cubic millimeters (mm\^3 will be used to evaluate this outcome)
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Secondary Outcomes (7)
Pharyngeal airway space (amount of movement)
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Direction of movement (advancement or setback)
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Apnea-hypopnea index (AHI) assessment
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Blood pressure changes
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Body mass index (BMI)
Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
- +2 more secondary outcomes
Study Arms (3)
Bimaxillary surgery (MMA)
ACTIVE COMPARATORBimaxillary Orthognathic Surgery. MMA
monomaxillary surgery (Isolated MaxS)
ACTIVE COMPARATORMonomaxillary surgery (Isolated MaxS)
monomandibullary surgery (Isolated MandS)
ACTIVE COMPARATORMonomandibular surgery (Isolated MandS)
Interventions
Treatment: Mono or Bimaxillary Orthognathic Surgery. The surgery of Reposition of the jaws is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
Monomaxillary surgery (Isolated MaxS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
Monomandibullary surgery (Isolated MandS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
Eligibility Criteria
You may qualify if:
- Patients over 18 years of age who present any kind of dentofacial deformity candidates for orthognathic surgery treatment.
- Growth of the maxillofacial complex completed.
- Patients without uncontrolled cardio-pulmonary disease.
- Patients willing to understand the procedures of the study and that agree to give their signed informed consent.
- Patients who commit to perform the postoperative controls for at least one postoperative year.
- Patients with a good general condition of health, confirmed by pre-operative study and assessment by Anaesthesiology (ASA).
You may not qualify if:
- Patients with a clinical history in which any surgery would be contraindicated
- Patients with any facial Syndromic malformation
- Patients who have undergone chemotherapy or radiotherapy during the last 5 years, including area of head and neck.
- Patients who refuse to accept the clinical conditions of the study and are not willing to sign the form corresponding informed consent.
- Patients who are expected to lack adherence to follow-up or to the treatment.
- Treatment with bisphosphonates or Denosumab (Prolia®).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Maxillofacial Surgery, Teknon Medical Center
Barcelona, 08022, Spain
Related Publications (3)
Giralt-Hernando M, Valls-Ontanon A, Guijarro-Martinez R, Masia-Gridilla J, Hernandez-Alfaro F. Impact of surgical maxillomandibular advancement upon pharyngeal airway volume and the apnoea-hypopnoea index in the treatment of obstructive sleep apnoea: systematic review and meta-analysis. BMJ Open Respir Res. 2019 Oct 9;6(1):e000402. doi: 10.1136/bmjresp-2019-000402. eCollection 2019.
PMID: 31673361BACKGROUNDGiralt-Hernando M, Valls-Ontanon A, Haas Junior OL, Masia-Gridilla J, Hernandez-Alfaro F. What are the Surgical Movements in Orthognathic Surgery That Most Affect the Upper Airways? A Three-Dimensional Analysis. J Oral Maxillofac Surg. 2021 Feb;79(2):450-462. doi: 10.1016/j.joms.2020.10.017. Epub 2020 Oct 15.
PMID: 33171114BACKGROUNDHernandez-Alfaro F, Giralt-Hernando M, Brabyn PJ, Haas OL Jr, Valls-Ontanon A. Variation between natural head orientation and Frankfort horizontal planes in orthognathic surgery patients: 187 consecutive cases. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1226-1232. doi: 10.1016/j.ijom.2021.02.011. Epub 2021 Feb 22.
PMID: 33632574BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Federico Hernández-Alfaro, PhD
Institute of Maxillofacial Surgery, Teknon Medical Center
- PRINCIPAL INVESTIGATOR
Adaia Valls-Ontañón, PhD
Institute of Maxillofacial Surgery, Teknon Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Oral and Maxillofacial Surgery Department
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 8, 2019
Study Start
April 30, 2018
Primary Completion
January 1, 2024
Study Completion
December 1, 2025
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share