UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055005 |
|---|---|
| Receipt number | R000062233 |
| Scientific Title | Prospective study of monolithic zirconia crowns and bridges |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/07/18 00:33:51 |
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Basic information
Public title
Prospective study of monolithic zirconia crowns and bridges
Acronym
Prospective study of monolithic zirconia crowns and bridges
Scientific Title
Prospective study of monolithic zirconia crowns and bridges
Scientific Title:Acronym
Prospective study of monolithic zirconia crowns and bridges
Region
| Japan |
Condition
Condition
Teeth and dental implants required fixed dental prosthesis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical performance of monolithic zirconia crowns and bridges with a fully digital workflow
Basic objectives2
Others
Basic objectives -Others
Cumulative success and survival rates
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative success and survival rates
Key secondary outcomes
To analyze the causes of the failure
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who requested fixed dental prosthesis
Patients who will have regular dental check-ups
Key exclusion criteria
Patients who will not be able to attend the clinic for over a year
Patients who have difficulty communicating due to poor judgment ability
When a patients request to decline research participation or withdraws consent
When fixed dental prosthesis break or debond
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Nakai |
Organization
Nakai Dental Office
Division name
Nakai Dental Office
Zip code
604-0916
Address
724-1 Yohoji-mae-cho, Nakagyo-ku, Kyoto
TEL
075-252-1020
nakai@ndo-kyoto.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Nakai |
Organization
Nakai Dental Office
Division name
Nakai Dental Office
Zip code
604-0916
Address
724-1 Yohoji-mae-cho, Nakagyo-ku, Kyoto
TEL
075-252-1020
Homepage URL
nakai@ndo-kyoto.jp
Sponsor or person
Institute
Nakai Dental Office
Institute
Department
Personal name
Nakai Nobuyuki
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Prosthetic Dentistry Graduate School of Biomedical Sciences Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences Administration Department General Affairs Division
Address
1-12-4, Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 18 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062233
| 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 |
