UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028311
Receipt number 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 23:10:11

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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 or person

Institute

The Nippon Dental University School of Life Dentistry at Niigata

Institute

Department

Personal name



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

Value
https://center6.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