UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053610 |
|---|---|
| Receipt number | R000061178 |
| Scientific Title | Observational Study on the Development of an Oral Condition Assessment System |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/04/19 12:14:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational Study on the Development of an Oral Condition Assessment System
Acronym
Development of an Oral Condition Assessment System
Scientific Title
Observational Study on the Development of an Oral Condition Assessment System
Scientific Title:Acronym
Development of an Oral Condition Assessment System
Region
| Japan |
Condition
Condition
Periodontal Disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a model for an Oral Condition Assessment System using intraoral photographs and dental chart data, and to compare its performance with other models to evaluate the effectiveness of this model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, Specificity, Accuracy, ROC-AUC, and F1 Score for the Detection of Periodontal Disease at the Individual Level
Key secondary outcomes
Sensitivity, Specificity, Accuracy, ROC-AUC, and F1 Score for the Detection of Periodontal Disease at the Single-Tooth Level
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are patients at a collaborative research institution and meet the following criteria (1) to (4):
(1) First-visit patients.
(2) Patients who are between 20 and 69 years old.
(3) Patients who have at least 20 natural teeth.
(4) Patients who have been provided with a written explanation and have given their consent.
When collecting data retrospectively, it is confirmed that the conditions (2) and (3) were met at the time of the first visit, and data is collected through an opt-out process.
Key exclusion criteria
(1) Patients who are undergoing orthodontic treatment.
(2) Patients who have more than five defective prostheses, crown restorations, or fillings, excluding inlays.
(3) Patients who are pregnant or lactating.
(4) Patients who are deemed unsuitable by the trial conductors or the attending dentists.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kato |
Organization
Sunstar Inc.
Division name
Oral Care, R&D
Zip code
566-0002
Address
Kento Innovation Park NK Building 7F, 3-17, Senrioka-Shinmachi, Settsu, Osaka, Japan
TEL
080-9937-4061
keisuke.kato@jp.sunstar.com
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Inoue |
Organization
Sunstar Inc.
Division name
Oral Care, R&D
Zip code
566-0002
Address
Kento Innovation Park NK Building 7F, 3-17, Senrioka-Shinmachi, Settsu, Osaka, Japan
TEL
070-2912-9045
Homepage URL
masaharu.inoue@jp.sunstar.com
Sponsor or person
Institute
Sunstar Inc.
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
(1) Sunstar Foundation
(2) DUO Dental Clinic, UShikubo Dental Office, Seiwa Medical Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Validity Evaluation Committee, Sunstar Inc.
Address
Asia One Center 8F, 1-17 koyochonaka, Higashinada-ku, Kobe,Hyogo, Japan
Tel
080-9937-4143
kentaro.yamashita@jp.sunstar.com
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
・サンスター株式会社（大阪府）
・一般財団法人サンスター財団附属千里歯科診療所（大阪府）
・医療法人晴和会うしくぼ歯科 DUOデンタルクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 14 | 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
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective and retrospective observational studies
Management information
Registered date
| 2024 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061178
