UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057089 |
|---|---|
| Receipt number | R000064877 |
| Scientific Title | Study on the caries-preventive effect of abrasives containing surface-reactive glass ionomer (S-PRG), a biological filler, on 6-year-old students at Ngo Quyen Elementary Schools in Can Tho City 2025.Double-blind, randomized, parallel-group study |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/10/02 22:36:54 |
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Basic information
Public title
Study on the caries-preventive effect of abrasives containing surface-reactive glass ionomer (S-PRG), a biological filler, on 6-year-old students at Ngo Quyen Elementary Schools in Can Tho City 2025.
Acronym
The caries-preventive effect of abrasives containing surface-reactive glass ionomer (S-PRG), a biological filler, on students
Scientific Title
Study on the caries-preventive effect of abrasives containing surface-reactive glass ionomer (S-PRG), a biological filler, on 6-year-old students at Ngo Quyen Elementary Schools in Can Tho City 2025.Double-blind, randomized, parallel-group study
Scientific Title:Acronym
The caries-preventive effect of abrasives containing surface-reactive glass ionomer (S-PRG), a biological filler, on students
Region
| Japan | Asia(except Japan) |
Condition
Condition
healthy person
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effect of abrasives containing S-PRG filler, a bioactive filler, at 3 and 6 months in the following intervention and control groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The International Caries Classification Disease Analysis System (ICDAS) will be used to evaluate caries activity in the S-PRG ProCare Gel surface-applied group and the control gel group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
S-PRG Pro Care Gel applied to the tooth surface
Interventions/Control_2
control gel groups
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
| 6 | years-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who consent to the study and participate voluntarily (requires a consent form and parental consent).
Key exclusion criteria
Children undergoing orthodontic treatment with fixed appliances.
Children who have undergone or just stopped caries treatment with topical fluoride within 6 months.
Children with a history of allergy to fluoride.
Children receiving treatment with drugs that cross-react with fluoride, such as chlorohexidine.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University Hospital
Division name
Department of Special care dentistry
Zip code
734-8551
Address
1-2-3 Kasumi Minami-ku
TEL
0822575727
okay@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Shintani |
Organization
Hiroshima University Hospital
Division name
Center of oral clinical examination
Zip code
7348551
Address
1-2-3 Kasumi Minami-ku
TEL
0822575727
Homepage URL
tshintan@hiroshima-u.ac.jp
Sponsor or person
Institute
Can Tho University of Medical and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi Minami-ku
Tel
0822571947
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
S6:+6au/QD-DH\DCT
Org. issuing International ID_1
Can Tho University of Medical and Pharmaceutical Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 20 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064877
