Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
NCT ID: NCT03796078
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2018-04-30
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea
NCT04124978
Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
NCT00477009
Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function
NCT05420129
Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients
NCT07301021
Changes of the Upper Airway Volume After Orthognathic Surgery
NCT05060133
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bimaxillary surgery (MMA)
Bimaxillary Orthognathic Surgery. MMA
Maxillomandibular advancement
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)
Monomaxillary surgery (Isolated MaxS)
monomaxillary surgery (isolated MaxS)
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)
Monomandibular surgery (Isolated MandS)
monomandibullary surgery (MandS)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maxillomandibular advancement
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)
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 (MandS)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Growth of the maxillofacial complex completed.
3. Patients without uncontrolled cardio-pulmonary disease.
4. Patients willing to understand the procedures of the study and that agree to give their signed informed consent.
5. Patients who commit to perform the postoperative controls for at least one postoperative year.
6. Patients with a good general condition of health, confirmed by pre-operative study and assessment by Anaesthesiology (ASA).
Exclusion Criteria
2. Patients with any facial Syndromic malformation
3. Patients who have undergone chemotherapy or radiotherapy during the last 5 years, including area of head and neck.
4. Patients who refuse to accept the clinical conditions of the study and are not willing to sign the form corresponding informed consent.
5. Patients who are expected to lack adherence to follow-up or to the treatment.
6. Treatment with bisphosphonates or Denosumab (Prolia®).
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro Medico Teknon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Federico Hernández-Alfaro MD, DDS, PhD, FEBOMS
Chief Oral and Maxillofacial Surgery Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Federico Hernández-Alfaro, PhD
Role: STUDY_CHAIR
Institute of Maxillofacial Surgery, Teknon Medical Center
Adaia Valls-Ontañón, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Maxillofacial Surgery, Teknon Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Maxillofacial Surgery, Teknon Medical Center
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Maria Giralt-Hernando, MSC
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Giralt-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.
Hernandez-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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OSAS-OS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.