UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027642 |
|---|---|
| Receipt number | R000031609 |
| Scientific Title | Statistical Analysis of Systemic Disorders and Oral Conditions in the Patients Treated in the Department of Special Care 1 at Tokyo Medical and Dental University |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2022/01/04 16:51:07 |
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Basic information
Public title
Statistical Analysis of Systemic Disorders and Oral Conditions in the Patients Treated in the Department of Special Care 1 at Tokyo Medical and Dental University
Acronym
Statistical Analysis of Systemic Disorders and Oral Conditions in the over 65 year-old Patients.
Scientific Title
Statistical Analysis of Systemic Disorders and Oral Conditions in the Patients Treated in the Department of Special Care 1 at Tokyo Medical and Dental University
Scientific Title:Acronym
Statistical Analysis of Systemic Disorders and Oral Conditions in the over 65 year-old Patients.
Region
| Japan |
Condition
Condition
over 65 years-old prevalence elderly
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze the rate of systemic disorders and correlation in between systemic disorder and oral conditions in over 65 years-old prevalence elderly.
Basic objectives2
Others
Basic objectives -Others
In order to treat the over 65 years-old prevalence elderly with systemic disorders during dental treatment, we will analyze the number and type of systemic disorders and oral conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We will analyze the number of systemic disorders and medicines administered in over 65 years-old prevalence elderly. In oral conditions, we will count the number of the teeth taking dental x-ray. The correlation in between systemic disorders, medicines, and oral conditions will be revealed.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who have medical examination in Tokyo Medical and Dental University of 1 special care clinic
Key exclusion criteria
The patients with no systemic disorders
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Kubota |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5582
kuboanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Kubota |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-4560
Homepage URL
Kazukubota211@aol.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None. Self funding.
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
東京医科歯科大学歯学部附属病院（東京都）、Dental Hospital, Tokyo Medical and Dental University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 24 | 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
83
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 01 | Day |
Other
Other related information
Statical analysis of systemic disorders in over 65 years-old prevalence elderly who need dental treatment. The correlation in between systemic disorders and oral conditions will be analyzed.
Management information
Registered date
| 2017 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031609
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
