UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051407 |
|---|---|
| Receipt number | R000058634 |
| Scientific Title | The effects of ICON on early caries prevention in orthodontic patients |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/06/21 18:15:57 |
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Basic information
Public title
The effects of ICON on early caries prevention in orthodontic patients
Acronym
The effects of ICON on early caries prevention in orthodontic patients
Scientific Title
The effects of ICON on early caries prevention in orthodontic patients
Scientific Title:Acronym
The effects of ICON on early caries prevention in orthodontic patients
Region
| Japan |
Condition
Condition
caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of caries prevention effect by ICON
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess presence or absence of white spots every 6 months from application
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Once at the start of treatment.
Usual dosage and administration.
Interventions/Control_2
Phosphoric acid is used as an etching agent.
Usual dosage and administration.
Interventions/Control_3
Standard caries prevention
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
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients starting orthodontic treatment using brackets
Key exclusion criteria
Restorative treatment has already been performed on the target tooth
Who cannot be treated safely
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KEIICHI |
| Middle name | |
| Last name | HOSAKA |
Organization
Tokushima University
Division name
Department of Regenerative Dental Medicine
Zip code
7708504
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
0886337340
yuki.h@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | HOSOKAWA |
Organization
Tokushima Univesity
Division name
Department of Regenerative Dental Medicine
Zip code
7708504
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
08863337340
Homepage URL
yuki.h@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
3-18-15, Kuramoto-cho, Tokushima
Tel
0886337340
yuki.h@tokushima-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058634
