UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040298 |
|---|---|
| Receipt number | R000045976 |
| Scientific Title | Using an ultrasonic microscope Establishment of non-invasive diagnostic method for caries and periodontal disease |
| Date of disclosure of the study information | 2020/05/02 |
| Last modified on | 2022/05/04 09:08:16 |
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Basic information
Public title
Using an ultrasonic microscope
Establishment of non-invasive diagnostic method for caries and periodontal disease
Acronym
Using an ultrasonic microscope
Establishment of non-invasive diagnostic method for caries and periodontal disease
Scientific Title
Using an ultrasonic microscope
Establishment of non-invasive diagnostic method for caries and periodontal disease
Scientific Title:Acronym
Using an ultrasonic microscope
Establishment of non-invasive diagnostic method for caries and periodontal disease
Region
| Japan |
Condition
Condition
caries and periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether an ultrasonic microscope is dentally useful
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acoustic impedance, hardness, element distribution
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
Dental caries: teeth determined to be suitable for tooth extraction due to caries (C3, C4, etc.)
Periodontitis: Teeth judged to be suitable for tooth extraction due to severe periodontitis (P3, etc.)
Wisdom Periodontitis: Teeth judged to be suitable for tooth extraction due to repeated pain and swelling
Key exclusion criteria
When the patient or the patient's family refuses to provide extracted teeth
Teeth that have been severely damaged and extracted
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Clinics of Dentistry for Disabled
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8438
at@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Naganuma |
Organization
Tohoku University Hospital
Division name
Clinics of Dentistry for Disabled
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8438
Homepage URL
dd169306@dent.tohoku.ac.jp
Sponsor or person
Institute
Clinics of Dentistry for Disabled, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Tohoku University ethics committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
med-kenkyo@grp.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
| 2020 | Year | 05 | Month | 02 | 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
| 2020 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The acoustic impedance value of the extracted tooth is measured with an ultrasonic microscope. In addition, hardness and elemental analysis are performed and the results are compared.
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
