UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005040 |
|---|---|
| Receipt number | R000005992 |
| Scientific Title | Availability of the tympanic membrane temperature measurement about treatment management is required by dental anesthesiology |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2011/02/06 20:40:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Availability of the tympanic membrane temperature measurement about treatment management is required by dental anesthesiology
Acronym
Availability of the tympanic membrane temperature measurement at sedation
Scientific Title
Availability of the tympanic membrane temperature measurement about treatment management is required by dental anesthesiology
Scientific Title:Acronym
Availability of the tympanic membrane temperature measurement at sedation
Region
| Japan |
Condition
Condition
Dental caries, Pericoronitis of wisdom tooth, benign tumor about dentistry
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By continuous measurement of body temperature at the time of the dental treatment that used sedatiion, we search about the utility of the product made in NIPRO company tympanic membrane temperature measurement instrument and degree of the body temperature altered
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, pulse, pulse oximeter, surgery time, anesthesia time, BIS monitor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The case that sedation needs by dental treatment
2. Written informed consent
Key exclusion criteria
1. Not written informed concent
2. The patient that tympanic membrane
temperature measurement is difficult
3. The patient that temperature of the
palm measurement is difficult
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto OOHASHI |
Organization
The Nippon Dental University Dental Hospital
Division name
Dental Anesthesia and General Health Management
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-1500
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi YAMADA |
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
025-267-1500
Homepage URL
Sponsor or person
Institute
The Nippon Dental University school of life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
NIPRO Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
日本歯科大学新潟病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 07 | 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
| 2010 | Year | 03 | Month | 15 | 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
We match the type with having complication or not and, at the time of the ympanic membrane temperature measurement, investigate it
Management information
Registered date
| 2011 | Year | 02 | Month | 06 | Day |
Last modified on
| 2011 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005992
