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Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome - Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013977
Enrollment
40
Registered
2014-05-16
Start date
2014-06-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Taking mandibular exercise about four weeks, before and after wearing OA Taking placebo exercise about four weeks, before and after wearing OA

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have hope for oral appliance therapy 2. Patients who have more than 20 teeth (including the residual anterial teeth) 3. Patients from whom written informed consent is obtained in this study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI), Oral health-related quality of life (OHIP-J), Health-related quality of life (SF-36)

Countries

Japan

Contacts

Public ContactShusuke Inukai

Tokyo Medical and Dental University Graduate school of Medical and Dental Sciences, Removable partial prosthodontics

shu.inukai.rpro@tmd.ac.jp03-5803-5515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026