UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003456 |
|---|---|
| Receipt number | R000004182 |
| Scientific Title | Retrieval of influence thatcontrol of noise generated at odontotherapy exerts on body |
| Date of disclosure of the study information | 2010/04/06 |
| Last modified on | 2011/04/14 15:03:56 |
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Basic information
Public title
Retrieval of influence thatcontrol of noise generated at odontotherapy exerts on body
Acronym
Control of noise generated at odontotherapy
Scientific Title
Retrieval of influence thatcontrol of noise generated at odontotherapy exerts on body
Scientific Title:Acronym
Control of noise generated at odontotherapy
Region
| Japan |
Condition
Condition
Teeth,Dental pulp,defect
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is a thing to retrieval of influence that control of noise generated at odontotherapy exerts on body
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, pulse,Spo2.catecholamine,Question
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
control group
Interventions/Control_2
crowd that shuts out the noise group
Interventions/Control_3
sedation group
Interventions/Control_4
crowd that shuts out the noise and sedation group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There are taken infomed concent among odontotherapy at Nippon Dental University Niigata Hospital
Key exclusion criteria
Patient of two degree or more of ASA classification
Age of under 20
Have a drug Allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sano Kimito |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asami Akiyama |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Nippon Dental University school of life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2010 | Year | 04 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 04 | Month | 06 | Day |
Last modified on
| 2011 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004182
