UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019463 |
|---|---|
| Receipt number | R000022499 |
| Scientific Title | Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2021/10/26 11:45:20 |
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Basic information
Public title
Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system
Acronym
Hybrid resin crown restorations for anterior tooth
Scientific Title
Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system
Scientific Title:Acronym
Hybrid resin crown restorations for anterior tooth
Region
| Japan |
Condition
Condition
tooth decay, treated tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate clinical performance of habrid resin crown restorations which improved homogeneity and a surface property as material at anterior tooth
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adaptation of CAD/CAM crowns
A: the border accept it if not recognize CAD/CAM crown and the border with the tooth plane with a explorer
B: it is possible and does the gap with impossibility
C:if both the border and the gap admit
D: if there are fracture and/or the detachment of crown
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
CAD/CAM hybrid resin rerstorations for anterior tooth
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation on participating to this study
Key exclusion criteria
The applicable patient intends for even one following conditions and excludes it.
1. Inappropriate abutment tooth (when there is the apical lesion) of the root canal treatment
2. Of the alveolar bone level when is low (when an alveolar bone level decreases more than 1/2)
3. When it is inappropriateness of the abutment construction
4. Buraxismcase with remarkable attrition 5. The case that the clearance of the occlusal surface cannot secure
6. When it becomes the abutment tooth of the removable partial denture
7. Of the opposing tooth when there is not it
8. Opposing tooth in the case of artificial teeth of removable partial denture
9. When, for a meta chestnut rate system polymer, there is an anamnesis of hypersensitivity such as a rash, dermatitis
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Yoshida |
Organization
Nagasaki Univesity Hospital
Division name
Clinic of Fixed Prosthodontics
Zip code
8528588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
keiichi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Yoshida |
Organization
Nagasaki Univesity Hospital
Division name
Clinic of Fixed Prosthodontics
Zip code
8528588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7688
Homepage URL
keiichi@nagasaki-u.ac.jp
Sponsor or person
Institute
Clinic of Fixed Prosthodontics, Nagasaki Univesity Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1, sakamoto, Nagasaki
Tel
095-819-7744
keichi@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
| 2015 | Year | 11 | 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
| 2015 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2022 | 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
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022499
