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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028311
Receipt No. R000032404
Scientific Title Study on change of the blood sugar level by eating and drinking intake restrictions at the time of the mandibular impacted wisdom tooth extraction.-Influence that the preoperative glucose dosage gives-
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/20

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Basic information
Public title Study on change of the blood sugar level by eating and drinking intake restrictions at the time of the mandibular impacted wisdom tooth extraction.-Influence that the preoperative glucose dosage gives-
Acronym Study on fluctuation of blood sugar level
Scientific Title Study on change of the blood sugar level by eating and drinking intake restrictions at the time of the mandibular impacted wisdom tooth extraction.-Influence that the preoperative glucose dosage gives-
Scientific Title:Acronym Study on fluctuation of blood sugar level
Region
Japan

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

Objectives
Narrative objectives1 Mandibular Implantation in Combination with Intravenous Sedation Method Drinking intake restriction is performed 4 hours before commencing tooth extraction, glucose is administered before surgery, and examination on fluctuation of blood sugar level after the operation is completed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Blood sugar level standard
2.Clinical findings
3.Vital sign
4.Sedation score
5.Electroencephalogram
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Intravenously administer 100 ml of 5% glucose solution.
Interventions/Control_2 Saline 100ml administered intravenously.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects sufficiently understood the purpose of this study and compared healthy adult males and females without history of diabetes with consent
Key exclusion criteria Patients with ASA classification two degree or higher
Patients under 20 years of age
Patients with drug allergy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mio Sekine
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Anesthesiology and Resuscitation
Zip code
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Email mi0@ngt.ndu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mio Sekine
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Anesthesiology and Resuscitation
Zip code
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Homepage URL
Email mi0@ngt.ndu.ac.jp

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

Funding Source
Organization None
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
Address
Tel
Email

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
2017 Year 07 Month 31 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
2017 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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