UMIN-CTR Clinical Trial

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	2021 Year 03 Month 05 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2024 Year 03 Month 31 Day

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	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049033