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

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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


Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name