UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019146 |
|---|---|
| Receipt number | R000022137 |
| Scientific Title | A study on the longevity of resin composite and cast restorations |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2019/03/18 09:03:00 |
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Basic information
Public title
A study on the longevity of resin composite and cast restorations
Acronym
A study on the longevity of resin composite and cast restorations
Scientific Title
A study on the longevity of resin composite and cast restorations
Scientific Title:Acronym
A study on the longevity of resin composite and cast restorations
Region
| Japan |
Condition
Condition
Dental caries and fracture of tooth and/ or restorative materials
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to provide more reliable evidence, long-term clinical performances of resin composite and cast restorations were investigated by using patients records.
To determine the cause of the re-treatment may be able to lead not only to improvement and development of restorative materials and techniques but also to prevent a recurrence.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restorations were examined and rated clinically acceptable, clinically unacceptable or already replaced according to the FDI criteria.
Survival time was defined as the age when the restoration was replaced, repaired, tooth extracted or diagnosed the need for such treatments.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients research leader was responsible since 1995.
- Patients from the document consent has been example cases (relocation, health, can not visit for reasons such as death, for those who agree in writing can not be obtained, to carry out information disclosure)
Key exclusion criteria
none
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shisei Kubo |
Organization
Nagasaki University Hospital
Division name
Medical Education Development Center
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7533
kubo@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shisei Kubo |
Organization
Nagasaki University Hospital
Division name
Medical Education Development Center
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7533
Homepage URL
kubo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 10 | Month | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Kubo S: Longevity of resin composite restorations. JDSR, 47: 43-55, 2011.
2.Survival rate of composite resin and casting repair; Japan Conservative Dentistry Journal,44,802-809,2001.
3.Kubo S, Kawasaki A, Hayashi Y: Factors associated with the longevity of resin composite restorations, Dent Mater J, 30: 374-383, 2011.
4.Nippon Dental save Gakkai. Second edition caries treatment guidelines,Kyoto,2015
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022137
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
