UMIN-CTR Clinical Trial

Basic information
Public title	Study on influence on intraoral sense (taste and the sense of touch) of the laughing gas for healthy adults
Acronym	Influence on intraoral sense of the laughing gas
Scientific Title	Study on influence on intraoral sense (taste and the sense of touch) of nitrous oxide for healthy adults
Scientific Title:Acronym	Influence on intraoral sense of nitrous oxide
Region	Japan

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

Objectives
Narrative objectives1	Nitrous oxide is discovered and is going to greet 250 years. Nitrous oxide was effective in the "painkilling" "sedation" "poor memory" and has been used for initial first aid at the time of delivery in dental treatment all over the world. By the dental treatment, many patients who came held uneasiness, strain, fear, the unpleasant feelings such as the pain, and such feelings have been used expecting an effect of the "sedation" "poor memory" among other things to enlarge the risk such as the aggravation of complications much less the resistance to the dental treatment of the patient. Nitrous oxide is shown to act on hearing and the sense of touch, optic restraint in a past study, but the influence on taste is not apparent. I have a sense of fear for the intraoral sense (taste and the sense of touch) except the sense of pain to feel during dental treatment in the dental phobia patient and may lead to a refusal action. It is intended that I clarify it about usefulness of the nitrous oxide use to a dental treatment patient by inspecting the effect to an intraoral sense of the nitrous oxide in this study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	I obtain its consent with predetermined written consent at the time of a study cooperation request. I let a target person obtained its consent reply a young man, an adult sense profile and a questionnaire. Under 0% of laughing gas (nitrous oxide), 20%, 30%, 50%, 70%, I carry out following experiments. 1.Blood pressure, the pulse, temperature, ventilatory frequency, the measurement of the percutaneous arterial blood oxygen saturation 2.Judgment (Ramsay score) of the sedation degree by the sedation score 3.The measurement (a mental stress activates excitement of the sympathetic system, and amylase activity increases as an internal self-defense reaction.) of saliva amylase 4.Examination of electric pulpal stimulation (A-delta fiber of four or five maxillary pulps, the threshold measurement by the C fiber stimulation) 5.The measurement of the surface of a body ache by the perception meter (10-20 g) and the oral pain 6.Examination of taste with the electric taste meter 7.Examination of taste with the reagent for examinations for taste qualitative fixed-quantity of the filter paper disk (sweetness, saltiness, acidity, bitterness) 8.Examination for R-R distance (examination of heart rate change)
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
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Interventions/Control_5
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	The person that I performed written informed consent by the adult volunteer including the student of Kyushu Dental College, and consent was provided.
Key exclusion criteria	The person who corresponds to a taboo of the laughing gas. Or the person that a case and the agreement that had difficulty in understanding of study contents were not provided.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name NOZOMU Middle name Last name HARANO
Organization	Kyushu Dental University
Division name	Dental Anesthesiology
Zip code	803-8580
Address	2-6-1, manaduru, kokurakitaku, kitakyushu city, Fukuoka, Japan
TEL	093-581-1131
Email	harano@kyu-dent.ac.jp

Public contact
Name of contact person	1st name Nozomu Middle name Last name Harano
Organization	Kyushu Dental University
Division name	Dental Anesthesiology
Zip code	803-8580
Address	2-6-1, manaduru, kokurakitaku, kitakyushu city, Fukuoka, Japan
TEL	093-581-1131
Homepage URL
Email	harano@kyu-dent.ac.jp

Sponsor
Institute	Kyushu Dental University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu Dental University
Address	2-6-1, manaduru, kokurakitaku, kitakyushu city, Fukuoka, Japan
Tel	093-701-9551
Email	harano@kyu-dent.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	2019 Year 08 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	2019 Year 04 Month 09 Day
Date of IRB	2019 Year 06 Month 03 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	There is no Important Notice.

Management information
Registered date	2019 Year 07 Month 24 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042709

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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