UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025133 |
|---|---|
| Receipt number | R000028901 |
| Scientific Title | Randomized controlled trial on the efficiency in removal of dental plaque related to changes of bristles' hardness of toothbrushes, Tuft 24 Soft and Medium |
| Date of disclosure of the study information | 2016/12/02 |
| Last modified on | 2022/04/14 12:11:50 |
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Basic information
Public title
Randomized controlled trial on the efficiency in removal of dental plaque related to changes of bristles' hardness of toothbrushes, Tuft 24 Soft and Medium
Acronym
Clinical trial on the efficiency in removal of dental plaque related to changes of bristles' hardness of toothbrushes
Scientific Title
Randomized controlled trial on the efficiency in removal of dental plaque related to changes of bristles' hardness of toothbrushes, Tuft 24 Soft and Medium
Scientific Title:Acronym
Clinical trial on the efficiency in removal of dental plaque related to changes of bristles' hardness of toothbrushes
Region
| Japan |
Condition
Condition
Healthy volunteers belonging to Hiroshima University
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association of toothbrush bristles' hardness with the efficiency in removal of dental plaque
Basic objectives2
Others
Basic objectives -Others
To examine whether Tuft 24 Soft is non-inferior to Medium in removal of dental plaque
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of dental plaque removal: PCR (Plaque Control Record) just before continuous use of an allocated toothbrush and 1, 2 and 3 month after use of it
Key secondary outcomes
Just before continuous use of an allocated toothbrush and 1, 2 and 3 month after use of it,
1. Percentage of dental plaque removal PHP (Patient Performance Record)
2. Hardness of toothbrush bristles
3. Frequency of tooth brushing during the study duration
4. Pressure of a toothbrush
5. Food during the period without tooth brushing
6. Area of worn toothbrush
7. Plaque area measurement
8.An investigation of deep learning using the bristle splaying image
9.1Evaluation of bristle abrasion using a SEM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects are healthy volunteers belonging to Hiroshima University. They are classified into 2 groups. One group consists of people relating to Course of Oral Science, while the other one consists of people not relating to the course. Tuft 24 soft toothbrush, which is randomly allocated to each subject. Everyone continues to use the allocated toothbrush for the successive 6 months. Just before continuous use of an allocated toothbrush and 1, 2 and 3 month after use of it, the efficiency in removal of dental plaque will be examined after 1 day suspension of tooth brushing.
Interventions/Control_2
Subjects are healthy volunteers belonging to Hiroshima University. They are classified into 2 groups. One group consists of people relating to Course of Oral Science, while the other one consists of people not relating to the course. Tuft 24 medium toothbrush, which is randomly allocated to each subject. Everyone continues to use the allocated toothbrush for the successive 6 months. Just before continuous use of an allocated toothbrush and 1, 2 and 3 month after use of it, the efficiency in removal of dental plaque will be examined after 1 day suspension of tooth brushing.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Undergraduate and postgraduate students studying at Kasumi campus of Hiroshima University fulfilling the following criteria;
1) Persons from 18 to 40 years old
2) Persons who agree to participate in this study with document.
3) Persons who have 18 teeth or more.
Key exclusion criteria
1) Persons who have crown restoration in several teeth or orthodontic appliances in the oral cavity.
2) Persons who receive treatment affecting oral condition in a medical clinic at present.
3) Women who are pregnant or supposed to be pregnant.
4) Persons who have been determined not to be suitable as subjects of this study
5) Persons who were classified into those requiring dental treatment based on a questionnaire and an intraoral examination before the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Ohta |
Organization
Hiroshima University
Division name
Dept. of Public Oral Health, Institute of Health & Biomedical Sciences
Zip code
7348553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-Shi, Hiroshima
TEL
082-257-5958
otkouji@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshino |
| Middle name | |
| Last name | Kaneyasu |
Organization
Hiroshima University
Division name
Dept. of Public Oral Health, Graduate School of Health & Biomedical Sciences
Zip code
7348553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-Shi, Hiroshima
TEL
082-257-5957
Homepage URL
yoshi-kane@hiroshima-u.ac.jp
Sponsor or person
Institute
Dept. of Public Oral Health, Institute of Health & Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Dept. of Public Oral Health, Institute of Health & Biomedical Sciences, Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University Hospital
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-Shi, Hiroshima
Tel
082-257-1551
iryo-seisaku@cimr.hiroshima-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
広島大学(広島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028901
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| Registered date | File name |
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