UMIN-CTR Clinical Trial

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
Email	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
Email	ossi106@ngt.ndu.ac.jp

Sponsor
Institute	The Nippon Dental University,School of Life Dentistry at Niigata
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046574