UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017067 |
|---|---|
| Receipt number | R000019797 |
| Scientific Title | Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart) |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2020/04/13 06:33:23 |
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Basic information
Public title
Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart)
Acronym
Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Scientific Title
Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart)
Scientific Title:Acronym
Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Region
| Japan |
Condition
Condition
Molar Caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
crack/fracture of crown, deslocated, condition of occlusal contact, condition of occlusal surface of crown/antagonistic teeth, crown color, plaque build-up, condition of interproximal contact, necessity of retreatment, pain, second caries
Key secondary outcomes
condition of metal allergy
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
application of CAD/CAM hybrid resin crown for molar teeth
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
treatment by crown for molar teeth, sufficient occlusal cleaeance, antagonistic teeth are existed
Key exclusion criteria
abutement tooth is infected by periodontal disease/apical periodontitis, clasped tooth, bruxism
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Koyano |
Organization
Kyushu University, Faculty of Dental Science
Division name
Division of Oral Rehabilitation
Zip code
8128582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
TEL
092-642-6441
koyano@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Ogino |
Organization
Kyushu University, Faculty of Dental Science
Division name
Division of Oral Rehabilitation
Zip code
8128582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
TEL
092-642-6441
Homepage URL
ogino@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Section of Implant and Rehabilitative Dentistry,Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
GC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University
Address
3-1-1 Maidashi Higashi-ku, Fukuoka
Tel
092-642-5774
nw-info@med.kyushu-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
九州大学病院義歯補綴科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
No published
Number of participants that the trial has enrolled
20
Results
Fracture 1
Unbonding 1
Results were provided to GC
Results date posted
| 2020 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Followed by protocol
Participant flow
Followed by protocol
Adverse events
Fracture 1
Unbonding 1
Outcome measures
Survival and success rate of crown in 12 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019797
| 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 |
