OSANCT03796078
Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
A study testing Maxillomandibular advancement, monomaxillary surgery (isolated MaxS) and monomandibullary surgery (MandS) in people with OSA and OSAS, run by Centro Medico Teknon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OSA, OSAS, Apnea, Obstructive Sleep
- What is being tested?
- Maxillomandibular advancement, monomaxillary surgery (isolated MaxS) and monomandibullary surgery (MandS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2018to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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®).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institute of Maxillofacial Surgery, Teknon Medical Center
Barcelona, 08022
Maria Giralt-Hernando, MSC, +34933 933 185 ext. 112
Adaia Valls-Ontañón, PhD, +34933 933 185 ext. 112, avalls@institutomaxilofacial.com
About this study
Official title: Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea
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.
Read more
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.
- Conditions
- OSA, OSAS, Apnea, Obstructive Sleep, Orthognathic Surgery
- Being tested
- Maxillomandibular advancement, monomaxillary surgery (isolated MaxS), monomandibullary surgery (MandS)
- Keywords
- OSA, orthognathic surgery
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillomandibular advancementProcedure or surgery
Also called 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)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bimaxillary surgery (MMA) | Active comparator | Bimaxillary Orthognathic Surgery. MMA Receives: Procedure: Maxillomandibular advancement |
| monomaxillary surgery (Isolated MaxS) | Active comparator | Monomaxillary surgery (Isolated MaxS) Receives: Procedure: monomaxillary surgery (isolated MaxS) |
| monomandibullary surgery (Isolated MandS) | Active comparator | Monomandibular surgery (Isolated MandS) Receives: Procedure: monomandibullary surgery (MandS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Evaluation of the amount of movement (pharyngeal airway space increase) 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. Millimeters will be used to determine this outcome
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Direction of movement (advancement or setback)
Evaluation of the direction of movement (advancement or setback) and its impact (negative/positive) in the total upper airway volume change, 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. Millimetres will be used to determine this outcome.
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Apnea-hypopnea index (AHI) assessment
Evaluation of clinical indicators of obstructive sleep apnea: Apnea-hypopnea index by polysomnography evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). AHI scale: Mild OSA 5-15/ moderate OSA: 15-30/ severe OSA: >30 events/hour. A higher score means a worse outcome.
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Blood pressure changes
Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained.
Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained.
Evaluation of clinical indicators of obstructive sleep apnea: blood pressure change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). Systolic and diastolic pressures will be both recorded. Mean cardiac frequency will be obtained. Assessed in mm Hg
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Body mass index (BMI)
Evaluation of Body mass index (e.g., weight in kilograms, height in m) change before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12). (e.g., weight and height will be combined to report BMI in kg/m^2).
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Lowest oxygen saturation 90% (LSat 90%)
Evaluation of clinical indicators of obstructive sleep apnea: lowest oxygen saturation (90%) change evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Epworth sleepiness scale test (ESS)
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. Used clinically to screen for the manifestations of the behavioral morbidity associated to obstructive sleep apnea, first used by Johns, 1991.
The ESS asks people to rate, on a four-point scale, their usual chances of falling asleep in eight different situations. These must be answered beyond 4 punctuations ranges depending on: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing or 3 = high chance of dozing. The total ESS score is the sum of item-scores and ranges between 0 and 24; the higher the score, the higher the person's level sleepines. A score of 10-12 is suggested as the cutoff among clinic populations being screened for a sleep disorder.
Measured: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start30 Apr 2018
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Federico Hernández-Alfaro MD, DDS, PhD, FEBOMS, Centro Medico Teknon
- Investigators
- Federico Hernández-Alfaro, PhD, Study chair, Institute of Maxillofacial Surgery, Teknon Medical CenterAdaia Valls-Ontañón, PhD, Principal investigator, Institute of Maxillofacial Surgery, Teknon Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796078
- Sponsor's protocol ID
- OSAS-OS
- Status last verified
- May 2023
- First submitted
- 3 Jan 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31673361Giralt-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.
PubMed 33171114Hernandez-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.
PubMed 33632574
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03796078
- Acronym / sponsor ID
- OSAS-OS
- Conditions
- OSA, OSAS, Apnea, Obstructive Sleep, Orthognathic Surgery
- Keywords
- OSA, orthognathic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimaxillary surgery (MMA) | Active comparator | Procedure: Maxillomandibular advancementBimaxillary Orthognathic Surgery. MMA |
| monomaxillary surgery (Isolated MaxS) | Active comparator | Procedure: monomaxillary surgery (isolated MaxS)Monomaxillary surgery (Isolated MaxS) |
| monomandibullary surgery (Isolated MandS) | Active comparator | Procedure: monomandibullary surgery (MandS)Monomandibular surgery (Isolated MandS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillomandibular advancementAlso: 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. | Procedure or surgery | Bimaxillary surgery (MMA) |
| 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. | Procedure or surgery | monomaxillary surgery (Isolated MaxS) |
| 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. | Procedure or surgery | monomandibullary surgery (Isolated MandS) |
Primary outcome
Upper airway volume change
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
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)
7 secondary outcomes
Pharyngeal airway space (amount of movement)
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Direction of movement (advancement or setback)
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Apnea-hypopnea index (AHI) assessment
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Blood pressure changes
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Body mass index (BMI)
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Lowest oxygen saturation 90% (LSat 90%)
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Epworth sleepiness scale test (ESS)
Time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 31673361Giralt-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.
- Background: PubMed 33171114Giralt-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.
- Background: PubMed 33632574Hernandez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Hernández-Alfaro, PhD study chair
Institute of Maxillofacial Surgery, Teknon Medical Center
Adaia Valls-Ontañón, PhD principal investigator
Institute of Maxillofacial Surgery, Teknon Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillomandibular advancement, monomaxillary surgery (isolated MaxS) and monomandibullary surgery (MandS) in people with OSA and OSAS, run by Centro Medico Teknon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Giralt-Hernando, PhD (+34933 933 185 ext. 112, mgiralt@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway volume change (time frame: Evaluated before surgery (Day 0), 1 month after surgery (Month 1) and 12 months after surgery (Month 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796078, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.