Last updated: May 12, 2023
Sponsor: Centro Medico Teknon
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sleep Apnea Syndromes
Treatment
monomaxillary surgery (isolated MaxS)
Maxillomandibular advancement
monomandibullary surgery (MandS)
Clinical Study ID
NCT03796078
OSAS-OS
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients over 18 years of age who present any kind of dentofacial deformity candidatesfor 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 givetheir signed informed consent.
- Patients who commit to perform the postoperative controls for at least onepostoperative year.
- Patients with a good general condition of health, confirmed by pre-operative study andassessment by Anaesthesiology (ASA).
Exclusion
Exclusion Criteria:
- 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 willingto 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®).
Study Design
Total Participants: 80
Treatment Group(s): 3
Primary Treatment: monomaxillary surgery (isolated MaxS)
Phase:
Study Start date:
April 30, 2018
Estimated Completion Date:
December 01, 2025
Connect with a study center
Institute of Maxillofacial Surgery, Teknon Medical Center
Barcelona, 08022
SpainActive - Recruiting
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