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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025133
Receipt No. 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 2020/07/21

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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

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 Koji
Middle name
Last name Ota
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
Email 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 082-257-5945
Homepage URL
Email d186958@hiroshima-u.ac.jp

Sponsor
Institute Dept. of Public Oral Health, Institute of Health & Biomedical Sciences, Hiroshima University
Institute
Department

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
Email 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
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 02 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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