Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Spain
Institute of Maxillofacial Surgery, Teknon Medical Center
RECRUITING
Barcelona
Contact Information
Primary
Maria Giralt-Hernando, PhD
mgiralt@uic.es
+34933 933 185
Backup
Adaia Valls-Ontañón, PhD
avalls@institutomaxilofacial.com
+34933 933 185
Time Frame
Start Date: 2018-04-30
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 80
Treatments
Active_comparator: Bimaxillary surgery (MMA)
Bimaxillary Orthognathic Surgery. MMA
Active_comparator: monomaxillary surgery (Isolated MaxS)
Monomaxillary surgery (Isolated MaxS)
Active_comparator: monomandibullary surgery (Isolated MandS)
Monomandibular surgery (Isolated MandS)
Sponsors
Leads: Centro Medico Teknon

This content was sourced from clinicaltrials.gov

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