UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062160 |
|---|---|
| Receipt number | R000071136 |
| Scientific Title | A non-randomized two-arm parallel comparative study of the usefulness of dental health guidance using an intraoral scanner compared with an intraoral camera |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/07 20:17:25 |
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Basic information
Public title
Evaluation of the usefulness of dental health guidance using an intraoral scanner: comparison with an intraoral camera
Acronym
Intraoral scanner dental health guidance study
Scientific Title
A non-randomized two-arm parallel comparative study of the usefulness of dental health guidance using an intraoral scanner compared with an intraoral camera
Scientific Title:Acronym
Intraoral scanner guidance comparative study
Region
| Japan |
Condition
Condition
Not applicable / Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of dental health guidance using an intraoral scanner with those using an intraoral camera in individuals aged 18 to under 30 years who have not received professional education in dentistry or oral health science.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Plaque Control Record (PCR) from baseline to 3 weeks after the initial dental health guidance
Key secondary outcomes
Changes in the stained plaque area ratio, changes in the area ratios of newly formed and mature plaque evaluated by two-tone plaque disclosing, changes in anterior PMA-index, understanding of the guidance content, motivation for oral hygiene, discomfort associated with the device used, and operator-rated usability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dental health guidance using an intraoral scanner (TRIOS 3, 3Shape) will be provided. After plaque disclosure, intraoral scanner images will be used to show the oral condition and plaque accumulation sites to the participants, and toothbrushing points and the basic technique of the Bass method will be explained. The intervention will be provided twice: at baseline and at the second visit, which will be conducted between 21 and 35 days after the initial guidance.
Interventions/Control_2
Dental health guidance using an intraoral camera (WAVE PICT SD, Yoshida) will be provided. After plaque disclosure, intraoral camera images will be used to show the oral condition and plaque accumulation sites to the participants, and toothbrushing points and the basic technique of the Bass method will be explained. The intervention will be provided twice: at baseline and at the second visit, which will be conducted after 21 days or later after the initial guidance.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following criteria will be included:
1. Individuals aged 18 to under 30 years at the time of consent
2. Individuals who have not received professional education in dentistry or oral health science; however, first-year dental students may be included
3. Individuals who provide written informed consent to participate in the study
Key exclusion criteria
Participants who meet any of the following criteria will be excluded:
1. Individuals with a history of allergy to plaque disclosing agents
2. Individuals with a severe gag reflex
3. Individuals who are judged by the principal investigator to be unsuitable for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rena |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Science Tokyo
Division name
Department of Oral Health Care Education
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-0239
rtakahasshi.ope@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Rena |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of scienn
Division name
Department of Oral Health Care Education
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-0239
Homepage URL
rtakahashi.ope@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
Research Ethics Committee Office, Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3726-1111
rinri.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 | 07 | Month | 07 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071136
