UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024361 |
|---|---|
| Receipt number | R000028044 |
| Scientific Title | Controlled trial about the stress caused by mis-deglutition prevention appliance reduction effect of the practiced hand of the deciduous tooth crown |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2016/10/11 16:46:28 |
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Basic information
Public title
Controlled trial about the stress caused by mis-deglutition prevention appliance reduction effect of the practiced hand of the deciduous tooth crown
Acronym
Stress caused by mis-deglutition prevention appliance reduction effect of the practiced hand of the deciduous tooth crown
Scientific Title
Controlled trial about the stress caused by mis-deglutition prevention appliance reduction effect of the practiced hand of the deciduous tooth crown
Scientific Title:Acronym
Stress caused by mis-deglutition prevention appliance reduction effect of the practiced hand of the deciduous tooth crown
Region
| Japan |
Condition
Condition
caries
Classification by specialty
| Dental medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is to evaluate the stress reduction effect of the practiced hand with the deciduous tooth crown (mis-deglutition prevention deciduous tooth crown) with the prevention of drinking by mistake function that we devised because there is safe dental treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, heart rate,o xygen saturation during dental treatment
Questionnaire after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Deciduous tooth crown with the mis-deglutition prevention appliance
Interventions/Control_2
Deciduous tooth crown without the mis-deglutition prevention appliance
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
dentist
Key exclusion criteria
without dentist
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Iwasaki |
Organization
Kagoshima University
Division name
Pediatirc dentistry
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima-City, Japan
TEL
+81-99-275-6262
yamame@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tmonori Iwasaki |
Organization
Kagoshima University
Division name
Pediatric Dentistry
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima-City, Japan
TEL
+81-99-275-626
Homepage URL
yamame@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
kagoshima University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 12 | Month | 10 | 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
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2016 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028044
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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