UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040784 |
|---|---|
| Receipt number | R000046574 |
| Scientific Title | General management of late elderly patients during dental treatment. |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2020/06/16 15:09:28 |
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Basic information
Public title
General management of late elderly patients in our department.
Acronym
General management of late elderly patients in our department.
Scientific Title
General management of late elderly patients during dental treatment.
Scientific Title:Acronym
General management of late elderly patients during dental treatment.
Region
| Japan |
Condition
Condition
all disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
General management during dental treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observe vital signs such as blood pressure, pulse rate, and electrocardiogram during the procedure.
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases over 75 years old
Key exclusion criteria
All cases under 74 years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Oshikiri |
Organization
The Nippon Dental University,School of Life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
9518580
Address
1-8 Hamauracho Chuoku, 951-8580 Niigata, Japan
TEL
0252671500
ossi106@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Oshikiri |
Organization
The Nippon Dental University,School of Life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
9518580
Address
1-8 Hamauracho Chuoku, 951-8580 Niigata, Japan
TEL
0252671500
Homepage URL
ossi106@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University,School of Life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University,School of Life Dentistry at Niigata
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
The Nippon Dental University,School of Life Dentistry at Niigata
Address
1-8 Hamauracho Chuoku, 951-8580 Niigata, Japan
Tel
0252671500
ossi106@ngt.ndu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood pressure, pulse rate, and electrocardiogram are observed during the procedure, and a retrospective study is conducted to determine whether there is any intraoperative abnormality.
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046574
| 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 |
