Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea

Launched by CENTRO MEDICO TEKNON · Jan 7, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring how a specific type of jaw surgery, called maxillomandibular advancement, can help people with obstructive sleep apnea (OSA). OSA is a condition where breathing stops and starts during sleep, often leading to snoring and daytime sleepiness. The study aims to understand how this surgery affects the size of the airway in the throat and various health indicators related to sleep apnea, such as the number of breathing interruptions during sleep and levels of daytime sleepiness.

To participate in the trial, individuals need to be at least 18 years old and have a jaw deformity that requires surgical correction. They should be in good health without severe heart or lung issues and must be willing to follow up for at least a year after the surgery. Participants will have their airway size and sleep apnea symptoms measured before the surgery and again at one month and one year afterward. This trial is important because it aims to show whether this surgery can provide lasting improvement for those suffering from OSA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients over 18 years of age who present any kind of dentofacial deformity candidates for orthognathic surgery treatment.
• • 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:
• • 1. Patients with a clinical history in which any surgery would be contraindicated
• • 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®).