UMIN-CTR Clinical Trial

Basic information
Public title	The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Acronym	The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Scientific Title	The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Scientific Title:Acronym	The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Region	Japan

Condition
Condition	Dental caries
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Detection of blood pressure variation by a new parameter esCCO that allows continuous measurement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference between esCCO-triggered manual blood pressure measurements and intermittent automatic blood pressure measurements
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Manual blood pressure measurement triggered by esCCO changes that occur within 5 minutes after the local anesthetic injection.
Interventions/Control_2	Manual blood pressure measurement in case of intraoperative esCCO changes
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults or adults with only well-controlled hypertension between 18 and 65 years old who are scheduled for dental treatment under intravenous sedation
Key exclusion criteria	Cardiovascular diseases other than hypertension, cerebrovascular, respiratory, hepatic, renal and psychiatric diseases, in addion to diabetes mellitus.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Wakita
Organization	Tokyo Medical and Dental University
Division name	Dental Anesthesiology and Orofacial Pain Medicine
Zip code	113-8549
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	0358035549
Email	ryoanph@tmd.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Wakita
Organization	Tokyo Medical and Dental University
Division name	Dental Anesthesiology and Orofacial Pain Medicine
Zip code	113-8549
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	0358035549
Homepage URL
Email	ryoanph@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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 Ethic Committee of Tokyo Medical and Dental University
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel	0358035404
Email	d-hyoka.adm@cmn.tmd.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	2022 Year 10 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 03 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 01 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055585