UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062778 |
|---|---|
| Receipt number | R000071235 |
| Scientific Title | Study on Photographic Detection Technology for Periodontal Disease |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/07/16 09:38:27 |
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Basic information
Public title
Study on Photographic Detection Technology for Periodontal Disease
Acronym
Study on Photographic Detection Technology for Periodontal Disease
Scientific Title
Study on Photographic Detection Technology for Periodontal Disease
Scientific Title:Acronym
Photograph-based Periodontal Disease Study
Region
| Japan |
Condition
Condition
Periodongal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the accuracy of an AI system for detecting periodontal disease by comparing it with the Community Periodontal Index (CPI). The results will be used to improve the machine learning model and enhance its detection accuracy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and Specificity of the CPI
Key secondary outcomes
Sensitivity and Specificity of AI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Comprehensive Periodontal Examination
Interventions/Control_2
Community Periodontal Index (CPI)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male or female participants aged 18 years or older at the time of providing informed consent.
2. Participants who voluntarily provide written informed consent to participate in this study.
3. Participants with at least one maxillary central incisor (right or left) and at least one mandibular central incisor (right or left).
4. Participants with available panoramic radiographs or a full-mouth periapical radiographic series (10 periapical radiographs).
5. Participants who are able to communicate sufficiently to participate in the study procedures.
Key exclusion criteria
1. Participants with oral mucosal diseases.
2. Participants who are unable to wear an angle wider.
3. Participants who are considered unsuitable for participation in the study by the Principal Investigator or a Sub-investigator.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | nobuhiro |
| Middle name | |
| Last name | Yoda |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178369
nobuhiro.yoda.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hihara |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178369
Homepage URL
hiroki.hihara.a4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Nobuhiro Yoda
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Dentistry, Tohoku University
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227178244
den-syom@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
| 2026 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071235
