Unique ID issued by UMIN | UMIN000007805 |
---|---|
Receipt number | R000009196 |
Scientific Title | A randomized, double-blind, placebo-controlled trial on the drug treatment on sleep bruxism |
Date of disclosure of the study information | 2012/04/21 |
Last modified on | 2019/08/27 13:25:25 |
A randomized, double-blind, placebo-controlled trial on the drug treatment on sleep bruxism
Effect of the drug on sleep bruxism
A randomized, double-blind, placebo-controlled trial on the drug treatment on sleep bruxism
Effect of the drug on sleep bruxism
Japan |
Sleep Bruxism
Dental medicine |
Others
NO
To reveal the effect of clonazepam and clonidine on sleep bruxism
Safety,Efficacy
Confirmatory
1. Frequency of sleep bruxism episodes
2. Masticatory muscle activity during sleep
3. Frequency of tooth grinding noises
1. Sleep-stage distribution
Interventional
Cross-over
Randomized
Double blind -all involved are blinded
Placebo
Numbered container method
6
Treatment
Medicine |
Clonazepam administration
(1.0mg, 1-day, before sleep)
(Wash out 2 weeks)
Clonidine administration
(0.15mg, 1-day, before sleep)
(Wash out 2 weeks)
Placebo administration
(1-day, before sleep)
Clonazepam administration
(1.0mg, 1-day, before sleep)
(Wash out 2 weeks)
Placebo administration
(1-day, before sleep)
(Wash out 2 weeks)
Clonidine administration
(0.15mg, 1-day, before sleep)
Clonidine administration
(0.15mg, 1-day, before sleep)
(Wash out 2 weeks)
Clonazepam administration
(1.0mg, 1-day, before sleep)
(Wash out 2 weeks)
Placebo administration
(1-day, before sleep)
Clonidine administration
(0.15mg, 1-day, before sleep)
(Wash out 2 weeks)
Placebo administration
(1-day, before sleep)
(Wash out 2 weeks)
Clonazepam administration
(1.0mg, 1-day, before sleep)
Placebo administration
(1-day, before sleep)
(Wash out 2 weeks)
Clonazepam administration
(1.0mg, 1-day, before sleep)
(Wash out 2 weeks)
Clonidine administration
(0.15mg, 1-day, before sleep)
Placebo administration
(1-day, before sleep)
(Wash out 2 weeks)
Clonidine administration
(0.15mg, 1-day, before sleep)
(Wash out 2 weeks)
Clonazepam administration
(1.0mg, 1-day, before sleep)
20 | years-old | <= |
60 | years-old | >= |
Male and Female
Patient with sleep bruxism
1. Individual with cardiovascular disease
2. Individual with respiratory disease
3. Individual with digestive system disease
4. Individual with brain disease
5. pregnant, during the nursing, possibly pregnant and having the hope of child bearing.
6. Individual with medicine
20
1st name | |
Middle name | |
Last name | Kazuyoshi Baba |
Showa University School of Dentistry
Department of Prosthodontics
2-1-1, Kitasenzoku, Ohta-ku, Tokyo, Japan
03-3787-1151
kazuyoshi@dent.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Baba Kazuyoshi |
Showa University School of Dentistry
Department of Prosthodontics
2-1-1, Kitasenzoku, Ohta-ku, Tokyo, Japan
03-3787-1151
kazuyoshi@dent.showa-u.ac.jp
Showa University School of Dentistry Department of Prosthodontics
Showa University
Other
NO
2012 | Year | 04 | Month | 21 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 13 | Day |
2012 | Year | 04 | Month | 01 | Day |
2016 | Year | 08 | Month | 31 | Day |
2012 | Year | 04 | Month | 21 | Day |
2019 | Year | 08 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009196
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |