UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000017067 |
| Receipt No. | 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 (Ver. 8) |
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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 |
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| Condition | ||
| Condition | Molar Caries | |
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| Institute | Section of Implant and Rehabilitative Dentistry,Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University |
| Institute | |
| Department | |
| 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 |
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| 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 |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Followed by protocol |
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| Participant flow | Followed by protocol |
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| Adverse events | Fracture 1 Unbonding 1 |
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| Outcome measures | Survival and success rate of crown in 12 months |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019797 |
