UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003325 |
|---|---|
| Receipt number | R000004037 |
| Scientific Title | Comparison of New Apatite Ionomer Cement and Conventional Glass Ionomer Cement used as ART Restorations & Sealants in Tongan School Children: A double-blinded, randomized, controlled and investigator-initiated clinical trial |
| Date of disclosure of the study information | 2010/04/04 |
| Last modified on | 2010/03/12 21:45:21 |
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Basic information
Public title
Comparison of New Apatite Ionomer Cement and Conventional Glass Ionomer Cement used as ART Restorations & Sealants in Tongan School Children: A double-blinded, randomized, controlled and investigator-initiated clinical trial
Acronym
Comparison of New Apatite Ionomer Cement and Conventional Glass Ionomer Cement used as ART Restorations & Sealants in Tongan School Children
Scientific Title
Comparison of New Apatite Ionomer Cement and Conventional Glass Ionomer Cement used as ART Restorations & Sealants in Tongan School Children: A double-blinded, randomized, controlled and investigator-initiated clinical trial
Scientific Title:Acronym
Comparison of New Apatite Ionomer Cement and Conventional Glass Ionomer Cement used as ART Restorations & Sealants in Tongan School Children
Region
| Australia |
Condition
Condition
Dental caries of primary and permanent teeth in healthy elementary school children
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy of new apatite ionomer cement and conventional glass ionomer cement used as ART restorations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Statas and maintenance rate of restrations, morbidity of secondary caries and survival rate of treated teeth after five or six months
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In ART restoration
Conventional GIC for restoration(powder and liquid of Fuji IX GP, GC Co., Tokyo, Japan )
Second primary molor (100 teeth)
Interventions/Control_2
In ART restoration
Conventional GIC for restoration (powder and liquid of Fuji IX GP)
First permanent molor (100 teeth)
Interventions/Control_3
In ART restoration
AGIC for restoration (Fuji IX GP powder with Hydroxyapatite powder(Spherical HAP, Taihei Industrial Co., Osaka, Japan) and Fuji IX liquid)
Second primary molor (100 teeth)
Interventions/Control_4
In ART restoration
AGIC for restoration (Fuji IX GP powder with Hydroxyapatite powder(Spherical HAP, Taihei Industrial Co., Osaka, Japan) and Fuji IX liquid)
First permanent molor (100 teeth)
Interventions/Control_5
In ART sealant
Conventional GIC for pit and fissure sealant (powder and liquid of Fuji III, GC Co., Tokyo, Japan)
Second primary molor (100 teeth)
Interventions/Control_6
In ART sealant
Conventional GIC for pit and fissure sealant (powder and liquid of Fuji III)
First permanent molor (100 teeth)
Interventions/Control_7
In ART sealant
AGIC for pit and fissure sealant (Fuji III powder with Spherical HAP and Fuji III liquid)
Second primary molor (100 teeth)
Interventions/Control_8
In ART sealant
AGIC for pit and fissure sealant Fuji III powder with Spherical HAP and Fuji III liquid)
First permanent molor (100 teeth)
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Intact teeth, enamel caries and dentin caries with no symptom or reversible pulpitis
Key exclusion criteria
Acute and chronic pulpitis and periodontitis
Treated teeth
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Arita |
Organization
The University of Tokushima Graduate School
Division name
Institute of Health Biosciences
Zip code
Address
3-18-15, Kuramoto, Tokushima, Japan
TEL
088-633-7359
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Arita |
Organization
The University of Tokushima Graduate School
Division name
Institute of Health Biosciences
Zip code
Address
3-18-15, Kuramoto, Tokushima, Japan
TEL
088-633-7359
Homepage URL
kenji@dent.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
Japanese Science and Technology Agency(JST)
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 04 | Month | 04 | 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
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | 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
| 2010 | Year | 03 | Month | 12 | Day |
Last modified on
| 2010 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004037
