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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000037462 |
Receipt No. | R000042709 |
Scientific Title | Study on influence on intraoral sense (taste and the sense of touch) of nitrous oxide for healthy adults |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2020/07/28 |
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 |
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Condition | |||
Condition | Dental phobia | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
harano@kyu-dent.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 | |
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | There is no Important Notice. |
Management information | |||||||
Registered date |
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |