UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035871 |
|---|---|
| Receipt number | R000040867 |
| Scientific Title | Clinical report and survival analysis of direct composite resin restorations |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2021/09/01 15:03:19 |
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Basic information
Public title
Clinical report and survival analysis of direct composite resin restorations
Acronym
Clinical report of direct composite resin restorations
Scientific Title
Clinical report and survival analysis of direct composite resin restorations
Scientific Title:Acronym
Clinical report of direct composite resin restorations
Region
| Japan |
Condition
Condition
Dental caries (C2), Root treated tooth, MT
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By long-term observation of the clinical prognostic process after direct composite restorations, we will investigate risk factors related to survival analysis and prognosis and look for criteria settings for indication judgment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of preoperative patient information, restoration design, adhesive material and postoperative trouble rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Design and technique of direct composite restoration
Interventions/Control_2
preoperative patient information
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
Subjects in this study are healthy minors who gained consent after explaining about direct composite resin restorations and can collect information from patient record and questionnaire.
Key exclusion criteria
Those who do not comply with the above selection criteria.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Tagami |
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences
Division name
Cariology and Operative Dentistry
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5483
tagami.ope@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Hosaka |
Organization
Tokyo Medical and Dental University
Division name
Cariology and Operative Dentistry
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5483
Homepage URL
keiichihosaka@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences, Cariology and Operative Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences, Cariology and Operative Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Habara dental clinic
Tashiro dental clinic
Total dental clinic Tokyo Aoi
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences, Cariology and Operative Dentistry
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel
03-5803-5483
060371ds@gmail.com
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
東京医科歯科大学歯学部附属病院
はばら歯科
田代歯科医院
トータル歯科東京青井
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040867
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
