Unique ID issued by UMIN | UMIN000049236 |
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Receipt number | R000056076 |
Scientific Title | A clinical study to evaluate the effect of oral appliance on sleep apnea syndrome |
Date of disclosure of the study information | 2022/10/17 |
Last modified on | 2023/10/19 18:15:32 |
A clinical study to evaluate the effect of oral appliance on sleep apnea syndrome
A clinical study to evaluate the effect of oral appliance on sleep apnea syndrome
A clinical study to evaluate the effect of oral appliance on sleep apnea syndrome
A clinical study to evaluate the effect of oral appliance on sleep apnea syndrome
Japan |
obstractive sleep apnea
Pneumology | Dental medicine |
Others
NO
We aimed to evaluate the effects of oral appliances on multiple teeth missing patients with obstructive sleep apnea with the reduction rate of the apnea hypopnea index as the primary endpoint. In addition, we evaluate the effect of oral appliance combined use for patients who have difficulty using nasal continuous positive airway pressure as the primary endpoint of AHI reduction rate.
Efficacy
the reduction rate of the apnea hypopnea index
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Maneuver |
OA for dentulous patients
OA for multiple teeth missing patients
OA for patients with who have difficulty using nasal continuous positive airway pressure
18 | years-old | <= |
Not applicable |
Male and Female
(1) Men and Women over 18 years
(2) Patients who have been diagnosed with OSA at the medical department and are planning to treat with OA at Tohoku University Hospital
(3) Patients who satisfy any of the following
Patients with 7 or fewer missing teeth in one jaw
Patients with 8 or more missing teeth in one jaw
Patients who have difficulty using CPAP
(1) Patients with temporomandibular disorder
(2) Patients undergoing orthodontic treatment
(3) Patients with severe periodontal disease
(4) Patients with low compliance to OA
(5) Patients with allergies to floor resin
(6) Women who are pregnant, possibly pregnant, within 28 days after childbirth
(7) Patients who are diagnosed to be difficult to participate in the study due to complication of psychosis or psychiatric symptoms
(8) Others
45
1st name | Toru |
Middle name | |
Last name | Ogawa |
Tohoku University Graduate School of Dentistry
Division of Advanced Prosthetic Dentistry
9808575
4-1 Seiryomachi-Aobaku Sendai
0227178369
toru.ogawa.d7@tohoku.ac.jp
1st name | Hiroki |
Middle name | |
Last name | Hihara |
Tohoku University Graduate School of Dentistry
Division of Advanced Prosthetic Dentistry
9808575
4-1 Seiryomachi-Aobaku Sendai
0227178369
hiroki.hihara.a4@tohoku.ac.jp
Tohoku University Graduate School of Dentistry
self-funding
Self funding
Tohoku University Graduate School of Dentistry Research Ethics Committee
4-1 Seiryo-machi, Aoba-ku,Sendai
0227178244
ec_den@rinri.hosp.tohoku.ac.jp
NO
2022 | Year | 10 | Month | 17 | Day |
Unpublished
Open public recruiting
2022 | Year | 10 | Month | 05 | Day |
2022 | Year | 10 | Month | 17 | Day |
2022 | Year | 11 | Month | 01 | Day |
2027 | Year | 09 | Month | 30 | Day |
2022 | Year | 10 | Month | 17 | Day |
2023 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056076
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