UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046335 |
|---|---|
| Receipt number | R000052871 |
| Scientific Title | Epidemiological study on dental caries risk factors by evaluation of tooth surface hardness and oral environment |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2022/12/10 12:53:53 |
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Basic information
Public title
Epidemiological study on dental caries risk factors by evaluation of tooth surface hardness and oral environment
Acronym
Estimating caries risk due to tooth hardness
Scientific Title
Epidemiological study on dental caries risk factors by evaluation of tooth surface hardness and oral environment
Scientific Title:Acronym
Estimating caries risk due to tooth hardness
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the relationship between the risk of dental caries from the evaluation of tooth hardness and the oral environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of dental caries
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who attend regular dental checkup
Key exclusion criteria
Those who have a major illness in the oral cavity.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Takeyoshi |
| Middle name | |
| Last name | Koseki |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Proventive Dentistry
Zip code
980-8575
Address
4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
TEL
0227178326
tkoseki@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takeyoshi |
| Middle name | |
| Last name | Koseki |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Proventive Dentistry
Zip code
980-8575
Address
4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
TEL
0227178327
Homepage URL
tkoseki@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohiku University
Address
4-1, Seiryomachi, Aobaku, Sendai, Miyagi, Japan
Tel
0227178326
tkoseki@dent.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2021 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe oral health at regular dental checkups.
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052871
