UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035609 |
|---|---|
| Receipt number | R000040565 |
| Scientific Title | Clinical study to assess the caries preventive and inhibitory effects of tooth coating materials on initial active root caries |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2024/01/26 13:56:41 |
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Basic information
Public title
Clinical study to assess the caries preventive and inhibitory effects of tooth coating materials on initial active root caries
Acronym
Clinical study to assess the anti-caries effects of tooth coating materials on initial root caries
Scientific Title
Clinical study to assess the caries preventive and inhibitory effects of tooth coating materials on initial active root caries
Scientific Title:Acronym
Clinical study to assess the anti-caries effects of tooth coating materials on initial root caries
Region
| Japan |
Condition
Condition
Initial active root caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the anti-caries efficacy of tooth coating materials on initial active root caries by conducting a randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Inspection every 3 months
Key secondary outcomes
Palpation
Oral photo taking
Diagnosis by laser
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tooth surface coating cement including fluorozinc silicate glass
Interventions/Control_2
Surface protectant glass ionomer cement
Interventions/Control_3
2 % sodium fluoride solution
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Permanent tooth with initial active root caries (less than 0.5 mm deepness, soft or leathery lesion)
Key exclusion criteria
Patients who are not able to visit clinic every 3 months
Patients who need operative care
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Restorative Dentistry and Endodontology
Zip code
5650871
Address
1-8 Yamadaoka, Suita
TEL
06-6879-2926
mikarin@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Asahi |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Restorative Dentistry and Endodontology
Zip code
5650871
Address
1-8 Yamadaoka, Suita
TEL
06-6879-2927
Homepage URL
yoko-a@dent.osaka-u.ac.jp
Sponsor or person
Institute
Department of Restorative Dentistry and Endodontology, Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Cariolology, Operative Dentistry and Endodontics, Department of Oral Health Science, Niigata University Graduate School of Medical and Dental Sciences
Department of Periodontology and Endodontology, Institute of Biomedical Sciences, Tokushima University Graduate School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board and ethics committee of Osaka University Dental Hospital
Address
1-8, Yamadaoka, Suita, Osaka
Tel
06-6879-5111
si-soumu-syomu@office.osaka-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
| 2019 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38256410/
Number of participants that the trial has enrolled
47
Results
A total of 58 lesions in 47 older adults were enrolled in this study. The plaque attachment rates tended to be lower in the material-coated root surfaces than in the healthy exposed root surfaces after 3, 6, and 12 months, although the differences among the three groups were not significant. Moreover, the coating material fall-out rate tended to be lower in the Caredyne group than in the Fuji VII group. There was no significant difference in the failure rate among the three groups at the 12 months mark.
Results date posted
| 2024 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients (more than 65 years old) with initial active root caries
Participant flow
Patients were randomly allocated to one of the following three groups: Caredyne ZIF-C, Fuji VII , and sodium fluoride. All the lesions were treated with the assigned materials without removing the infected dentin, and evaluated after 3, 6, and 12 months.
Adverse events
No adverse events were observed.
Outcome measures
The primary outcome was inspection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040565
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