UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062699 |
|---|---|
| Receipt number | R000071778 |
| Scientific Title | Development of an AI-Based Feedback System for Tooth Preparation Assessment and Verification of Its Educational Effects on Dental Residents |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/26 15:49:43 |
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Basic information
Public title
Development of an AI-Based Feedback System for Tooth Preparation Assessment and Verification of Its Educational Effects on Dental Residents
Acronym
Development of an AI-Based Feedback System for Tooth Preparation Assessment and Verification of Its Educational Effects on Dental Residents
Scientific Title
Development of an AI-Based Feedback System for Tooth Preparation Assessment and Verification of Its Educational Effects on Dental Residents
Scientific Title:Acronym
Development of an AI-Based Feedback System for Tooth Preparation Assessment and Verification of Its Educational Effects on Dental Residents
Region
| Japan |
Condition
Condition
Condition Health Condition(s) or Problem(s) studied:Dental education / Clinical skill training
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tooth preparation for abutments, reducing and shaping teeth to fabricate indirect restorations such as crowns and bridges, is a core clinical skill in prosthodontics that determines the marginal fit and long-term prognosis of prosthetic restorations. However, in the postgraduate clinical training program at our hospital, tooth preparation practice is not part of the formal curriculum, and dental residents currently practice on their own initiative during free time. In this self-directed practice, residents may occasionally receive evaluations when they request them from supervising dentists; however, as supervisors are heavily occupied with clinical and educational duties, such opportunities are limited, and no systematic framework for evaluation and feedback exists. Moreover, even when preparation skills are assessed in undergraduate or postgraduate education, the judgment depends on supervisors' subjective assessment, raising concerns about the objectivity and reproducibility of evaluations (inter- and intra-rater reliability). Consequently, the quality and consistency of feedback to learners are not necessarily assured.
Recently, with the widespread adoption of dental 3D scanners, the morphology of prepared teeth (e.g., taper angle, axial wall height, and continuity of the finish line) can be quantitatively analyzed as digital data. However, no established system automatically scores these data using artificial intelligence (AI) and presents the results as verbal educational feedback.
This study aims to develop an AI-based system that automatically scores and verbalizes the quality of tooth preparation from 3D scan data, and (1) to examine the agreement between AI and supervisor (expert) evaluations, and (2) to investigate the educational effectiveness of immediate AI feedback through a randomized comparison with supervisor feedback.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group difference in the rate of improvement calculated from the changes in preparation accuracy scores (AI-generated scores) over Phase 1 (10 sessions in total).
Key secondary outcomes
1.Rate of improvement in preparation accuracy scores during Phase 2 (secondary analysis accounting for carryover effects)
2.Agreement between AI-generated scores and supervising dentists' scores
3.Changes in self-assessed confidence measured by questionnaires at each time point (before the practice sessions, at the end of Phase 1, and after the end of Phase 2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: After tooth preparation, an AI system analyzes STL data obtained via 3D scanning and provides feedback through an AR-based visualization of reduction amount, taper angle, and other scores with evaluative comments.
Control group: After tooth preparation, trainees receive standard verbal feedback from a supervising dentist.
Interventions/Control_2
Control group: After tooth preparation, trainees receive standard verbal feedback from a supervising dentist.
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 residents in clinical training at Okayama University Hospital who have provided written informed consent to participate in the tooth preparation practice sessions and in this study.
Key exclusion criteria
Those who do not provide consent to participate in the study
Those otherwise judged ineligible by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Taketa |
Organization
Okayama University Hospital
Division name
Dentistry (Division of Comprehensive Dentistry)
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-6788
taketa-h@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Takada |
Organization
Okayama University Hospital
Division name
Dentistry (Division of Comprehensive Dentistry)
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-6788
Homepage URL
pqpy3pap@s.okayana-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
Tel
086-235-6938
mae6605@adm.okayama-u.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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | 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 | 21 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071778
