UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061321 |
|---|---|
| Receipt number | R000070160 |
| Scientific Title | Establishment of a method for detection and longitudinal management of root caries using optical diagnostic techniques |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/20 13:40:31 |
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Basic information
Public title
Establishment of a method for detection and longitudinal management of root caries using optical diagnostic techniques
Acronym
Root Caries Optical Diagnostic Study
Scientific Title
Establishment of a method for detection and longitudinal management of root caries using optical diagnostic techniques
Scientific Title:Acronym
Root Caries Optical Diagnostic Study
Region
| Japan |
Condition
Condition
Root caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish an objective method for longitudinal monitoring of root caries by evaluating the usefulness of demineralization values and images obtained with an optical diagnostic device for detecting root caries and assessing lesion activity, arrest, and progression.
Basic objectives2
Others
Basic objectives -Others
Detection of root caries, assessment of lesion activity, and establishment of a longitudinal monitoring method
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between demineralization values and image findings obtained by the optical diagnostic device and the clinical assessment of root caries activity at baseline and follow-up
Key secondary outcomes
Association between optical diagnostic measurements and visual findings for detecting root caries
Discriminative ability between active and arrested lesions
Longitudinal changes in demineralization values
Intra-examiner and inter-examiner reproducibility
Association between lesion progression during follow-up and optical findings
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who provide written informed consent for participation in this study.
Individuals who have teeth suspected of having root caries or teeth with root caries lesions.
Individuals who can undergo measurements using the optical diagnostic device and follow-up assessments.
Individuals who are able to attend scheduled visits during the study period.
Key exclusion criteria
Individuals who do not present with gingival recession
Individuals with five or more missing teeth
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Hamba |
Organization
Tokyo Dental College
Division name
Department of Operative Dentistry, Cariology and Pulp Biology
Zip code
101-0061
Address
2-9-18, Kanda-Misakicho, Chiyoda-ku, Tokyo
TEL
03-6380-9127
ope@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Hamba |
Organization
Tokyo Dental College
Division name
Department of Operative Dentistry, Cariology and Pulp Biology
Zip code
101-0061
Address
2-9-18, Kanda-Misakicho, Chiyoda-ku, Tokyo
TEL
03-6380-9127
Homepage URL
ope@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokyo Dental College
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
Tel
03-6380-9114
drinri@tdc.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
| 2026 | Year | 04 | Month | 21 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center prospective observational study. Demineralization values and images will be obtained using an optical diagnostic device in participants with suspected root caries or root caries lesions, and root caries detection, lesion activity or arrest, and longitudinal changes will be observed at baseline and follow-up visits.
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070160
