UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033737
Receipt number R000038306
Scientific Title Effect of salivary test on medical treatment for behaviors of diabetic patients
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/10 18:53:01

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Basic information

Public title

Effect of salivary test on medical treatment for behaviors of diabetic patients

Acronym

Effect of salivary test on medical treatment for behaviors of diabetic patients

Scientific Title

Effect of salivary test on medical treatment for behaviors of diabetic patients

Scientific Title:Acronym

Effect of salivary test on medical treatment for behaviors of diabetic patients

Region

Japan


Condition

Condition

Diabetes mellitus, Periodontal disease

Classification by specialty

Endocrinology and Metabolism Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess change of diabetes patient's behavior with salivary test and dental instruction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of treatment behavior

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Salivary test

Interventions/Control_2

No salivary test

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Uncontrolled diabetes (HbA1c >=7.4%),
No dental treatment for 1 year and
Periodontal Risk Score >=0.25.

Key exclusion criteria

None

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuichi Kuribayashi

Organization

Misaki internal medicine clinic

Division name

Internal Medicine

Zip code


Address

6-44-9, Futawahigashi, Funabashi, Chiba, Japan

TEL

047-440-2222

Email

misakin@bh.wakwak.com


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Kudo

Organization

Misaki internal medicine clinic

Division name

Internal Medicine

Zip code


Address

6-44-9, Futawahigashi, Funabashi, Chiba, Japan

TEL

047-440-2222

Homepage URL


Email

misakin@bh.wakwak.com


Sponsor or person

Institute

Misaki internal medicine clinic

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

2018 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Enrolling by invitation

Date of protocol fixation

2017 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 01 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

2018 Year 08 Month 13 Day

Last modified on

2018 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name