obstructive sleep apnea. Sleep apnoea
Conditions
Interventions
Intervention 1: Using advanced mandible splint with jaw protrusion in intervention group so that a record of jaws relation is taken while the patient is protruding lower jaw and in the next step Essix
Treatment - Devices
Placebo
placebo device (oral device without jaw protrusion) in control group
Using advanced mandible splint with jaw protrusion in intervention group so that a record of jaws relation is taken while the patient is protruding lower jaw and in the next step Essix clear device is
Sponsors
Vice Chancellor for Research, Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria:Age more than 18 years, Willing to participate in the study, Having mild to moderate obstructive sleep apnea (Apnea Hypopnoea Index of 5 to 30), Having enough marginal dental adaptation Exclusion criteria: Having Periodontal or other kind of oral cavity disease, Having contraindication for cephalometry (such as pregnancy), Having Advanced temporomandibular joint disease, Having contraindication for body MRI
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index per hours during sleep. Timepoint: before intervention and 1 month after intervention. Method of measurement: polysomnography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Oropharyngeal volumetry. Timepoint: at the beginning, with and without Mandibular Advancement Splint in interventional group. Method of measurement: Oropharyngeal MRI.;Sleep quality and daytime sleepiness. Timepoint: before intervention and 1 month after intervention in interventional and control groups. Method of measurement: sleep quality questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahnaz Amini
Mashhad University of Medical Sciences
Outcome results
None listed