UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018061 |
|---|---|
| Receipt number | R000020756 |
| Scientific Title | Development of a periodontal disease-related questionnaire: PD-Q study |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2015/12/28 17:03:41 |
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Basic information
Public title
Development of a periodontal disease-related questionnaire: PD-Q study
Acronym
Development of a periodontal disease-related questionnaire: PD-Q study
Scientific Title
Development of a periodontal disease-related questionnaire: PD-Q study
Scientific Title:Acronym
Development of a periodontal disease-related questionnaire: PD-Q study
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a periodontal disease-related questionnaire.
Basic objectives2
Others
Basic objectives -Others
To develop a periodontal disease-related questionnaire.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Question items examining clinical status and QOL in the mouth
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
40 year-old or older male and female
Key exclusion criteria
39 year-old or elder male and female
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Mafune |
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name
Division of research and development
Zip code
Address
Chuo-ku, Tokyo 103-8234, Japan
TEL
03-5255-6330
mafune.eiichi.ds@daiichisankyo-hc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisahiro Kamoi |
Organization
NIPPON MEDICAL SCHOOL CHIBA HOKUSOH HOSPITAL
Division name
Dentistry
Zip code
Address
1715 kamagari, Inzai, Chiba 270-1694 Japan
TEL
0476-99-1111
Homepage URL
hisakamo@nms.ac.jp
Sponsor or person
Institute
DAIICHI SANKYO HEALTHCARE CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD.
DeNA Life Sciece, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
日本医科大学千葉北総病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The questionnaire items asking the clinical status and QOL
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020756
