UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057641 |
|---|---|
| Receipt number | R000065860 |
| Scientific Title | Non-randomized controlled trial on the effectiveness of oral hygiene instruction using an intraoral scanner |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/04/17 15:02:51 |
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Basic information
Public title
Effectiveness of oral hygiene instruction using an intraoral scanner
Acronym
Effectiveness of oral hygiene instruction using an intraoral scanner
Scientific Title
Non-randomized controlled trial on the effectiveness of oral hygiene instruction using an intraoral scanner
Scientific Title:Acronym
Non-randomized controlled trial on the effectiveness of oral hygiene instruction using an intraoral scanner
Region
| Japan |
Condition
Condition
healthy adults, periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of dental health guidance applying an intraoral scanner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in oral hygiene 2-3 weeks after instruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide oral hygiene instruction using intraoral scanner images at the time of initial intervention and evaluate improvement in oral hygiene after 2 weeks
Interventions/Control_2
Conventional oral hygiene instruction using a hand mirror is given at the time of initial intervention, and improvement in oral hygiene is evaluated after 2 weeks.
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
University students who are between 18 and 30 years of age at the time of consent
Those who have given their consent to participate in the research.
Key exclusion criteria
Those who could not give their consent to participate in the research
Those who have not received professional education in dentistry or oral health.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Oral Health Care Education
Zip code
1138549
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358034649
suzuki.ohce@tmd.ac.jp
Public contact
Name of contact person
| 1st name | hitomi |
| Middle name | |
| Last name | suzuki |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Oral Health Care Education
Zip code
1138549
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358034649
Homepage URL
suzuki.ohce@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, 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
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Address
1-5-45 Yushima Bunkyo-ku Tokyo
Tel
0358034649
suzuki.ohce@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
| 2025 | Year | 08 | 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
| 2025 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065860
