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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002684
Receipt No. 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

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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
Email

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
Email r-ochide@med.uoeh-u.ac.jp

Sponsor
Institute Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003210

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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