UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048378
Receipt number R000055140
Scientific Title Establishment of a novel method for the evaluation of bruxism using wearable electromyometer
Date of disclosure of the study information 2022/08/01
Last modified on 2023/01/13 10:28:00

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Basic information

Public title

Establishment of a novel method for the evaluation of bruxism using wearable electromyometer

Acronym

Establishment of a novel method for the evaluation of bruxism using wearable electromyometer

Scientific Title

Establishment of a novel method for the evaluation of bruxism using wearable electromyometer

Scientific Title:Acronym

Establishment of a novel method for the evaluation of bruxism using wearable electromyometer

Region

Japan


Condition

Condition

bruxism, periodontal disease

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the effect of occlusal adjustment to bruxism

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation by wearable electromyometer

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Over 18 years old
Patients who are aware of having bruxism and/ or expected to have bruxism

Key exclusion criteria

Patients having psychiatric disorders
Patients missing premolars and molars

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Katagiri
Middle name
Last name Sayaka

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5488

Email

katagiri.peri@tmd.ac.jp


Public contact

Name of contact person

1st name Katagiri
Middle name
Last name Sayaka

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5488

Homepage URL


Email

katagiri.peri@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of the Faculty of Dentistry, TMDU

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-5404

Email

d-hyoka.adm@tmd.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



Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 01 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

Preinitiation

Date of protocol fixation

2022 Year 08 Month 01 Day

Date of IRB

2022 Year 11 Month 25 Day

Anticipated trial start date

2023 Year 03 Month 01 Day

Last follow-up date

2025 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study


Management information

Registered date

2022 Year 07 Month 14 Day

Last modified on

2023 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name