UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002923 |
|---|---|
| Receipt number | R000003221 |
| Scientific Title | A randomized controlled trial on the effect of gastric-acid inhibiting drug on sleep bruxism and oral disease |
| Date of disclosure of the study information | 2009/12/25 |
| Last modified on | 2011/02/09 15:54:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial on the effect of gastric-acid inhibiting drug on sleep bruxism and oral disease
Acronym
Effect of gastric-acid inhibiting drug on sleep bruxism
Scientific Title
A randomized controlled trial on the effect of gastric-acid inhibiting drug on sleep bruxism and oral disease
Scientific Title:Acronym
Effect of gastric-acid inhibiting drug on sleep bruxism
Region
| Japan |
Condition
Condition
Sleep Bruxism
Classification by specialty
| Gastroenterology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of gastric-acid inhibiting drug on sleep bruxism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
1. Frequency of sleep bruxism episodes
2. Masticatory muscle activity during sleep
Key secondary outcomes
1. Frequency of tooth grinding noises
2. Frequency of gastro-esophageal reflux episodes
3. Sleep-stage distribution
4. Frequency of micro-arousals
5. Gastrointestinal symptoms on awakening
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infusion of an acdic solution into the esophagus
(0.1N HCl, 5ml, multiple infusion per night)
Interventions/Control_2
Infusion of a saline into the esophagus
(Saline, 5ml, multiple infusion per night)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adult without sleep bruxism
Key exclusion criteria
1. Individual with secondary sleep bruxism
2. Individual with sleep disorder except sleep bruxism
3. Individual with gastro-intestinal disease
4. Individual with any medication within three months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Miyawaki |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Orthodontics
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagoshima University, Graduate School of Medical and Dental Sciences
Division name
Department of Orthodontics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthodontics, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Osaka City University
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鹿児島大学医学部・歯学部附属病院(鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The frequencies of EMG bursts, rhythmic masticatory muscle activity (RMMA) episodes, grinding noise, and the RMMA/microarousal ratio were significantly higher in the 20-min period after acidic infusion than after saline infusion. RMMA episodes including SB were induced by esophageal acidification.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 21 | Day |
Last modified on
| 2011 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003221
