UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041559 |
|---|---|
| Receipt number | 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 | 2023/02/26 09:49:04 |
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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
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
hosaka.ope@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Terminated
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
| 2023 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047451
| 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 |
