UMIN-CTR Clinical Trial

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
Email	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
Email	dd169306@dent.tohoku.ac.jp

Sponsor
Institute	Clinics of Dentistry for Disabled, Tohoku University Hospital
Institute
Department

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
Email	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	2020 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045976

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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