UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005968 |
|---|---|
| Receipt number | R000007052 |
| Scientific Title | An investigation into the adherence of bacterial florae to various abutment materials |
| Date of disclosure of the study information | 2011/07/13 |
| Last modified on | 2013/07/05 08:59:53 |
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Basic information
Public title
An investigation into the adherence of bacterial florae to various abutment materials
Acronym
An investigation into the adherence of bacterial florae to various abutment materials
Scientific Title
An investigation into the adherence of bacterial florae to various abutment materials
Scientific Title:Acronym
An investigation into the adherence of bacterial florae to various abutment materials
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate plaques on various implant materials and reveal the factor affect an implant therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
florae
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Thirty subjects wear removable acrylic devices on which several kinds of disks are attached, for five days, except times for eating and toothbrushing.
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
| 25 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subject apply to the age restriction above (25 to 35 years)
Key exclusion criteria
no informed consent
Bleeding tendency
History of diabetes
Use of Removable denture
Use of antibiotics
History of moderate to severe periodontitis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Koyano |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Yamane |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
TEL
Homepage URL
dd101054@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
| 2011 | Year | 07 | Month | 12 | Day |
Last modified on
| 2013 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007052
