Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome
- Conditions
- Obstructive Sleep Apnea Syndrome
- Registration Number
- JPRN-UMIN000013977
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1. AHI<5, or AHI>30 and BMI>30 2. Patients who have received OSAS treatment such as surgery or OA therapy previously 3. Patients who have chronic nasal congestion, a high degree of tonsillar hypertrophy 4. Patients who will be received combined OA and nCPAP therapy 5. The amount of mandible protrusion is less than 4mm 6. Patients who have received drug therapy related sleep, temporomandibular symptom (hypnotic, analgesic, anxiolytic) 7. Diagnosed as mental disorders 8. Patients who drink alcohol in most of day 9. Patients who diagnosed temporomandibular disorders by the RDC/TMD in preoperative examination (except only the clicking ) 10. Patients who have suffered from pain in cervico-omo-section 11. Patients who need dental treatment for caries and periodontal disease in oral cavity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We evaluate after two weeks, one month and three months of wearing OA. Limitations of daily function (LDF-TMDQ), TMJ pain(VAS), The presence or absence of temporomandibular disorders by clinical examination, OA compliance
- Secondary Outcome Measures
Name Time Method Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI), Oral health-related quality of life (OHIP-J), Health-related quality of life (SF-36)