UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060981 |
|---|---|
| Receipt number | R000069781 |
| Scientific Title | Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging. |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/19 09:08:37 |
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Basic information
Public title
Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging.
Acronym
Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging.
Scientific Title
Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging.
Scientific Title:Acronym
Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging.
Region
| Japan |
Condition
Condition
A research of Cone-beam CT imaging for periodontitis.
Classification by specialty
| Radiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cone-beam CT for dental use (CBCT) is widely used in dental care, but it tends to result in higher patient radiation doses compared to other X-ray examinations such as periapical radiography and panoramic radiography. In this study, we applied a Massive Training Artificial Neural Network (MTANN), a small-data AI, to CBCT images and developed an AI model that predicts high-dose images even under low-dose conditions. The purpose of this study is to investigate whether this AI model is effective for actual clinical images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In addition to imaging at standard doses used in clinical practice, low-dose imaging will be performed. High-dose virtual images will be generated from the obtained low-dose images using an AI model, and their visualization capabilities will be evaluated against standard-dose images to determine their non-inferiority.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
From June 2025 to March 2028, patients who visit the periodontal disease outpatient clinic at Institute of Science Tokyo Hospital and meet the criteria of Section 4.2 of the research protocol (selection policy for research subjects) will undergo low-dose radiography in addition to standard clinical dose radiography. The planned number of cases is 60.
Interventions/Control_2
From June 2025 to March 2028, patients who visit the periodontal disease outpatient clinic at Institute of Science Tokyo Hospital and meet the criteria of Section 4.2 of the research protocol (selection policy for research subjects) will undergo low-dose radiography in addition to standard clinical dose radiography. The planned number of cases is 60.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with a clinical indication requiring dental CBCT imaging.
Individuals aged 20 to under 80 years old at the time of obtaining consent.
Individuals who have provided written consent to participate in the study.
Gender is not a factor.
Key exclusion criteria
Pregnant or breastfeeding individuals.
Individuals with severe renal impairment.
Other individuals deemed unsuitable by the principal investigator or co-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Institute of Science Tokyo
Division name
Department of Dental Radiology and Radiation Oncology
Zip code
1138549
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5545
hiro.orad@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Institute of Science Tokyo
Division name
Department of Dental Radiology and Radiation Oncology
Zip code
113-8549
Address
Yushima 1-5-45. Bunkyo-ku, Tokyo
TEL
03-5803-5545
Homepage URL
hiro.orad@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rec.adm@tmd.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 | 03 | Month | 19 | 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 | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 02 | 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
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069781
