Status:
UNKNOWN
Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Centro Medico Teknon
Conditions:
OSA
OSAS
Eligibility:
All Genders
18+ years
Phase:
NA
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. ME...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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®).
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03796078
Start Date
April 30 2018
End Date
December 1 2025
Last Update
May 16 2023
Active Locations (1)
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1
Institute of Maxillofacial Surgery, Teknon Medical Center
Barcelona, Spain, 08022