UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002684 |
|---|---|
| Receipt number | R000003210 |
| Scientific Title | The short-term effect of daily fluoride rinsing in adults: a randomized controlled trial |
| Date of disclosure of the study information | 2009/11/06 |
| Last modified on | 2010/06/04 15:45:44 |
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Basic information
Public title
The short-term effect of daily fluoride rinsing in adults: a randomized controlled trial
Acronym
The short-term effect of daily fluoride rinsing in adluts
Scientific Title
The short-term effect of daily fluoride rinsing in adults: a randomized controlled trial
Scientific Title:Acronym
The short-term effect of daily fluoride rinsing in adluts
Region
| Japan |
Condition
Condition
Periodontal disease
Sensitive teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of daily fluoride rinsing on periodontal condition and sensitive teeth
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of biomarker levels in gingival crevicular fluid and oral symptoms at one month after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Fluoride mouth rinse group: to use fluoride mouthwash (0.05% NaF) twice per working day. It is directed to rinse for at least 30 seconds during about 4-week period.
Interventions/Control_2
Placebo group: tap water rinsing twice per working day. It is directed to rinse for at least 30 seconds during about 4-week period in the same way as an intervention group.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*Subjects with sensitive teeth
Key exclusion criteria
*Subjects who cannot participate the study due to occupational conditions.
*Subjects who have intension not to participate in an intervention program.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Ide |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Work Systems and Health, Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
093-603-1611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Ide |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Work Systems and Health, Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
093-603-1611
Homepage URL
r-ochide@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
8020 Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no significant difference between fluoride mouth rinse and placebo groups in biomarker levels in gingival crevicular fluid at baseline and post intervention.
Fluoride mouth rinse group was less likely to have symptoms of gum swelling, painful aching, and painful gums at post intervention, when compared to placebo group.
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 28 | Day |
Last modified on
| 2010 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
