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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041559
Receipt No. R000047451
Scientific Title An observational clinical trial of adhesively bonded biological restoration using an autogenous tooth with a digital workflow
Date of disclosure of the study information 2020/10/01
Last modified on 2021/02/25

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Basic information
Public title An observational clinical trial of adhesively bonded biological restoration using an autogenous enamel of extracted tooth
Acronym An observational clinical trial of adhesive biological restoration using an autogenous tooth with a digital workflow
Scientific Title An observational clinical trial of adhesively bonded biological restoration using an autogenous tooth with a digital workflow
Scientific Title:Acronym An observational clinical trial of adhesive restoration using an autogenous tooth with a digital workflow
Region
Japan

Condition
Condition Cases requiring full or partial crown restoration, direct bridge, full mouth reconstruction
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using digital technologies such as intra-oral scanning and CAD/CAM, the crown shape of the extracted tooth is processed accurately in a very short time. The prepared crown and targeted tooth are adhesively bonded. The purpose of this observational clinical study is to examine the clinical efficacy of the newly developed biological treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The survival rate, success rate, patient satisfaction, and the amount of wear are measured to compare with the conventional methods.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Processing of extracted crown and adhesively bonded restoration
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 Subjects in this study are healthy minors who gained consent after explaining adhesively bonded restorations and can collect information from patient records and questionnaires.
Key exclusion criteria Those who do not comply with the above selection criteria.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Hosaka
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 113-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5483
Email hosaka.ope@tmd.ac.jp

Public contact
Name of contact person
1st name Keiichi
Middle name
Last name Hosaka
Organization Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Ora
Division name Cariology and Operative Dentistry
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5483
Homepage URL
Email hosaka.ope@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University, Ethics Committee
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5406
Email d-hyoka.adm@tmd.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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 10 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
2020 Year 08 Month 26 Day
Date of IRB
2020 Year 12 Month 10 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2025 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
2020 Year 08 Month 26 Day
Last modified on
2021 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047451

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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