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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042978
Receipt No. R000049033
Scientific Title The impact of noise during dental treatment on dental health care personnel
Date of disclosure of the study information 2021/01/18
Last modified on 2021/01/12

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Basic information
Public title The impact of noise during dental treatment on dental health care personnel
Acronym The impact of noise during dental treatment on dental health care personnel
Scientific Title The impact of noise during dental treatment on dental health care personnel
Scientific Title:Acronym The impact of noise during dental treatment on dental health care personnel
Region
Japan

Condition
Condition none
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In dental treatment, noise is occurred/generated due to the use of various devices. It is known that noise causes deafness and thought disturbance. In this study, the effects of noise during dental treatment are evaluated through the crossover test using the noise-canceling device.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the work efficiency (Under background noise and noise during dental treatment with or without the noise-canceling device)
Key secondary outcomes 1.Work accuracy
2.Psychological condition
(Under background noise and noise during dental treatment with or without the noise-canceling device)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The dental profession in the Dental Hospital of Tokyo Medical and Dental University
Key exclusion criteria Deafness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Sachi
Middle name
Last name Umemori
Organization Dental Hospital of Tokyo Medical and Dental University
Division name General Dentistry
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5766
Email sachi.u.gend@tmd.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Kido
Organization Dental Hospital of Tokyo Medical and Dental University
Division name General Dentistry
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5766
Homepage URL
Email kidperi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5766
Email sachi.u.gend@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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 18 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
2020 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 11 Day
Last follow-up date
2022 Year 02 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Changes in the work efficiency (Under background noise and noise during dental treatment with or without the noise-canceling device)

Management information
Registered date
2021 Year 01 Month 12 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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