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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035871
Receipt No. 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 2019/02/13

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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
Middle name
Last name Tagami Junji
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
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL 03-5803-5483
Email tagami.ope@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hosaka Keiichi
Organization Tokyo Medical and Dental University
Division name Cariology and Operative Dentistry
Zip code
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL 03-5803-5483
Homepage URL
Email keiichihosaka@gmail.com

Sponsor
Institute Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences, Cariology and Operative Dentistry
Institute
Department

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
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 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 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 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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