UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015934 |
|---|---|
| Receipt number | R000018538 |
| Scientific Title | Clinical Evaluation of Composite in Direct Class I and Class II Posterior Restorations |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2014/12/13 17:22:27 |
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Basic information
Public title
Clinical Evaluation of Composite in Direct Class I and Class II Posterior Restorations
Acronym
Clinical Evaluation of Composite in Posterior Restorations
Scientific Title
Clinical Evaluation of Composite in Direct Class I and Class II Posterior Restorations
Scientific Title:Acronym
Clinical Evaluation of Composite in Posterior Restorations
Region
| Japan |
Condition
Condition
caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate the clinical performance of an composite in posterior restorations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluated using modified United States Public Health Service (USPHS) criteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interventions:experimental composite resin, more than 3 years
Interventions/Control_2
Control_1: control composite resin, more than 3 years
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all posterior carious cases expect for clinical cases with the exclusion criterias
Key exclusion criteria
poor oral hygiene, severe periodontitis, heavy bruxism, known allergy to any of the materials used, diagnosis of painful pulp pathology, periapical diseases identified radiographically, rampant caries, and atypical extrinsic staining of the teeth.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kitasako |
Organization
Tokyo Medical and Dental University
Division name
Division of Cariology and Operative Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5483
kitasako.ope@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kitasako |
Organization
Tokyo Medical and Dental University
Division name
Division of Cariology and Operative Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5483
Homepage URL
kitasako.ope@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
Address
Tel
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
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 13 | Day |
Last modified on
| 2014 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018538
