UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005350
Receipt number R000006354
Scientific Title Frequency and the mechanism of RMMA induced by esophageal acidification
Date of disclosure of the study information 2011/03/31
Last modified on 2023/03/13 15:21:31

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Basic information

Public title

Frequency and the mechanism of RMMA induced by esophageal acidification

Acronym

Frequency and the mechanism of RMMA induced by esophageal acidification

Scientific Title

Frequency and the mechanism of RMMA induced by esophageal acidification

Scientific Title:Acronym

Frequency and the mechanism of RMMA induced by esophageal acidification

Region

Japan


Condition

Condition

Bruxism

Classification by specialty

Gastroenterology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the effect of esophageal acidification on masticatory muscle activity

Basic objectives2

Others

Basic objectives -Others

To reveal the effect of stress and esophageal acidification on masticatory muscle activity

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Masticatory muscle activity
Frequency of swallowing

Key secondary outcomes

Autonomic nurve activity
Esophageal acid clearance
Brain activity


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

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Infusion of an acdic solution into the esophagus
(0.1N HCl, multiple infusion)

Interventions/Control_2

Infusion of a saline into the esophagus
(Saline, multiple infusion)

Interventions/Control_3

stress induced by calculation task

Interventions/Control_4

reading

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

60 years-old >

Gender

Male

Key inclusion criteria

Healthy adult without bruxism

Key exclusion criteria

1. Individual with bruxism
2. Individual with gastro-intestinal disease
3. Individual with temporomandibular disorders
4. Individual with any medication within three months

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Shouichi
Middle name
Last name Miyawaki

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Department of Orthodontics

Zip code

890-8544

Address

8-35-1, Sakuragaoka, Kagoshima, Japan

TEL

099-275-6252

Email

miyawaki@dent.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Mika
Middle name
Last name Fukushima

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Department of Orthodontics

Zip code

890-8544

Address

8-35-1, Sakuragaoka, Kagoshima, Japan

TEL

099-275-6252

Homepage URL


Email

fukushima@dent.kagoshima-u.ac.jp


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

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima University Hospital

Address

8-35-1, Sakuragaoka, Kagoshima, Japan

Tel

099-275-6624

Email

crmc@m2.kufm.kagoshima-u.ac.jp


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

鹿児島大学病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2011 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Main results already published

Date of protocol fixation

2011 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 30 Day

Last modified on

2023 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name