UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042450 |
|---|---|
| Receipt number | R000048099 |
| Scientific Title | Exploratory study of surface changes of dental restoration materials in oral environment |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2023/11/17 11:16:52 |
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Basic information
Public title
Exploratory study of surface changes of dental restoration materials in oral environment
Acronym
Exploratory study of surface changes of dental restoration materials in oral environment
Scientific Title
Exploratory study of surface changes of dental restoration materials in oral environment
Scientific Title:Acronym
Exploratory study of surface changes of dental restoration materials in oral environment
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the restorative materials surface and biofilm formation, when these materials are placed in oral of healthy persons.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surface change of each restorative materials after 6h
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Restoration materials (composite resin) are temporally attached to a healthy person.
Interventions/Control_2
Restoration materials (glass ionomer cement) are temporally attached to a healthy person.
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
1) 20 years of age or more
2) Person who obtain the consent
3) Person who have all 4 premolars on both sides
Key exclusion criteria
1) Those who are allergic to dental materials
2) Women who are pregnant or may become pregnant
3) lactating women
4) Not appropriate to this study judged by investigator or related
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Maruo |
Organization
Okayama University Hospital
Division name
Occlusion and Removable Prosthodontics
Zip code
700-8558
Address
2-5-1, Shikata-cho, Okayama
TEL
086-235-6687
ykmar@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Maruo |
Organization
Okayama University Hospital
Division name
Occlusion and Removable Prosthodontics
Zip code
700-8558
Address
2-5-1, Shikata-cho, Okayama
TEL
086-235-6687
Homepage URL
https://www.okayama-u.ac.jp/user/hospital/en/index153.html
ykmar@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1, Shikata-cho, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048099
