UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021135 |
|---|---|
| Receipt number | R000024379 |
| Scientific Title | Natural initialcaries caries lesions remineralization by chewing sugar-free gum containing bio-available fluoride |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2018/02/23 09:58:24 |
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Basic information
Public title
Natural initialcaries caries lesions remineralization by chewing sugar-free gum containing bio-available fluoride
Acronym
Initial caries lesions remineralization by chewing gum
Scientific Title
Natural initialcaries caries lesions remineralization by chewing sugar-free gum containing bio-available fluoride
Scientific Title:Acronym
Initial caries lesions remineralization by chewing gum
Region
| Japan |
Condition
Condition
initial caries lesion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of chewing gum containing fluoride on natural initial caries lesions remineralization
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
surface property of initial caries lesions are evaluated by ICDAS score
Key secondary outcomes
lesion depth of initial caries are evaluated using OCT images
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
daily chewing gum containing bioaveialble calcium and fluoride over 3 months
Interventions/Control_2
daily chewing gum containing bioaveialble fluoride over 3 months
Interventions/Control_3
daily chewing placebo gum over 3 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For inclusion in the study, the subjects were required to have at least one WSL, with an ICDAS score of 2 or 1
Key exclusion criteria
Exclusion criteria included smoking, evidence of poor oral health including periodontal disease, recent professional fluoride therapy (<2 weeks), uptake of fluoridated water or any medication that could affect oral flora, and pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tagami Junji |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Cariology and Operative Dentistry
Zip code
Address
5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-5483
tagami.ope@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kitasako Yuichi |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Cariology and Operative Dentistry
Zip code
Address
5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
kitasako.ope@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2016 | Year | 02 | Month | 22 | 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
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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024379
