UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035609
Receipt No. 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 2019/01/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open -no one is 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 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikako Hayashi
Organization Osaka University Graduate School of Dentistry
Division name Department of Restorative Dentistry and Endodontology
Zip code
Address 1-8 Yamadaoka, Suita
TEL 06-6879-2926
Email mikarin@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Asahi
Organization Osaka University Graduate School of Dentistry
Division name Department of Restorative Dentistry and Endodontology
Zip code
Address 1-8 Yamadaoka, Suita
TEL 06-6879-2927
Homepage URL
Email yoko-a@dent.osaka-u.ac.jp

Sponsor
Institute Department of Restorative Dentistry and Endodontology, Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Osaka 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
Address
Tel
Email

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 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 21 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
2019 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040565

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.