UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062188 |
|---|---|
| Receipt number | R000071081 |
| Scientific Title | Effect of Combined Toothbrushing and Interdental Cleaning Devices on Interdental Dental Plaque Removal in Middle-Aged and Older Adults: A Randomized, Single-Blind, Crossover Trial |
| Date of disclosure of the study information | 2026/07/09 |
| Last modified on | 2026/07/09 15:38:53 |
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Basic information
Public title
A Randomized, Single-Blind, Crossover Trial Evaluating the Effect of Combined Toothbrushing and Interdental Cleaning Devices on Interdental Dental Plaque Removal in Middle-Aged and Older Adults
Acronym
A Study on the Effectiveness of Toothbrushing and Interdental Cleaning Devices for Dental Plaque Removal
Scientific Title
Effect of Combined Toothbrushing and Interdental Cleaning Devices on Interdental Dental Plaque Removal in Middle-Aged and Older Adults: A Randomized, Single-Blind, Crossover Trial
Scientific Title:Acronym
Toothbrushing and Interdental Cleaning Trial
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of combined toothbrushing with an interdental brush versus combined toothbrushing with dental floss for interdental dental plaque removal in middle-aged and older adults, and to evaluate cleaning time, cleaning efficiency, and user acceptability of each interdental cleaning device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Dental Plaque Removal Rate (%)
Key secondary outcomes
1. Interdental cleaning time per interdental site (seconds)
2. Participant-reported outcomes assessed by a post-use questionnaire (perceived gingival trauma, perceived cleaning effectiveness, ease of use, perceived complexity of use, and intention to continue use)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
interdental brush
Intervention
Study participants will use interdental brushes at home for five days, beginning six days before the test. On the day of the test, after brushing their teeth with a standard toothbrush, they will clean the target interdental spaces using interdental brushes. Under a crossover design, Group A will undergo this intervention in Test I, and Group B will undergo it in Test II.
Interventions/Control_2
Holder-type dental floss
Intervention
Study participants will use floss with a holder at home for five days, beginning six days before the test. On the day of the test, after brushing their teeth with a designated toothbrush, they will clean the target interdental spaces using floss with a holder. Under a crossover design, Group A will undergo this intervention in Test II, and Group B will undergo it in Test I.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 50 years or older
2. Having at least five interdental spaces in the molar region, excluding third molars, into which dental floss can be inserted
Key exclusion criteria
1. Presence of oral diseases, such as multiple dental caries or severe periodontitis
2. Unable to use interdental cleaning devices because of gingival swelling, suppuration, or other related conditions
3. Current use of anticoagulant medication
4. Considered ineligible by the investigator (dentist) for any other reason
5. Unable to use interdental cleaning devices appropriately
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Shimada |
Organization
Osaka Dental University
Division name
Department of Oral Health Sciences, Faculty of Health Sciences
Zip code
5731144
Address
1-4-4 Makinohonmachi, Hirakata, Osaka
TEL
072-856-9953
shimada-a@cc.osaka-dent.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Shimada |
Organization
Osaka Dental University
Division name
Department of Oral Health Sciences, Faculty of Health Sciences
Zip code
5731144
Address
1-4-4 Makinohonmachi, Hirakata, Osaka
TEL
072-856-9953
Homepage URL
shimada-a@cc.osaka-dent.ac.jp
Sponsor or person
Institute
Osaka Dental University
Institute
Department
Personal name
Shimada Akiko
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Osaka Dental University
Address
8-1 Kuzuhahanazono-cho, Hirakata, Osaka
Tel
072-864-3111
oduresearch@cc.osaka-dent.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
大阪歯科大学附属病院（大阪）、西宮北口歯科（兵庫）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 09 | 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 | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2027 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071081
