UMIN-CTR Clinical Trial

Public title

Multi-Institutional Collaborative Cohort Study on the improvement of marker for diabetes mellitus and oral malodor by periodontal treatment (MICCS-DOP)

Acronym

Improvement of DM and halitosis by periodontal treatment

Scientific Title

Multi-Institutional Collaborative Cohort Study on the improvement of marker for diabetes mellitus and oral malodor by periodontal treatment (MICCS-DOP)

Scientific Title:Acronym

Improvement of DM and halitosis by periodontal treatment

Region

Japan

Condition

Diabetes Mellitus
Periodontal Disease

Classification by specialty

Medicine in general

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Assessment for the usability of simple halitosis test on self-management and prevention of lifestyle-related diseases by analyzing the relationship between periodontal disease, diabetes mellitus and halitosis

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. test value for diabetes mellitus: HbA1c, LDL, HDL, TG, FBS
2. test value for periodontal desease: pocket depth, bleeding on probing, tooth mobility, IgG titer against periodontal pathogens, bone loss index
3. halitosis test level: bless checker level
4. Inflammatory marker: WBC, hs-CRP

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

A) Moderate diabetic outpatient under treatment for diabetes (fasting blood sugar: over 126 mg/dl or HbA1c[NGSP]: over 6.5% )
B) New patient with periodontal disease: Patients with suspected diabetes (in the case of the refference from dental clinc to medical clinic)
C) Healthy subject without diabetes and periodontal disease

Key exclusion criteria

A) Patient with a serious liver disease or renal disease
B) Patient with malignant tumor
C) Poorly controlled diabetic patient
(fasting blood sugar: over 160 mg/dl or HbA1c[NGSP]: over 8.4% )
D) Patient scheduled for surgery
E) In addition, patient being deemed inappropriate as subject in this study by the dentist

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University

Division name

Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Zip code

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan

TEL

086-235-6675

Email

stakashi@cc.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shogo Takashiba

Organization

Okayama University

Division name

Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pha

Zip code

Address

stakashi@cc.okayama-u.ac.jp

TEL

086-235-6675

Homepage URL

Email

stakashi@cc.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

Okayama University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人 社団建歯会 青木歯科医院（歯科・吹田市），池歯科医院（歯科・淀川区），伊津歯科医院（歯科・八尾市），デンタルクリニック　イマホリ（歯科・枚方市），杉本歯科診療所（歯科・岸和田市），牛嶋歯科医院（歯科・交野市），小澤歯科医院（歯科・西成区），カタオカ歯科医院（歯科・豊中市），医療法人 永隆会 川植歯科医院（歯科・岸和田市），貴島歯科（歯科・東大阪市），倉歯科医院（歯科・西成区），こいずみ歯科クリニック（歯科・住吉区），高津歯科医院（歯科・旭区），高麗歯科医院（歯科・北区），小山歯科医院（歯科・枚方市），近藤歯科医院（歯科・池田市），近藤歯科医院（歯科・淀川区），坂本歯科医院（歯科・泉南市），さわい歯科医院（歯科・都島区），新宅歯科医院（歯科・河内長野市），杉本歯科医院（歯科・柏原市），瀬戸歯科医院（歯科・西成区），医療法人 柏康会 デンタクリニックT.T.C（歯科・東大阪市），辻本歯科医院（歯科・城東区），医療法人 緑志会 寺嶋歯科医院（歯科・西成区），田島診療所歯科（歯科・生野区），とうじ歯科医院（歯科・東淀川区），とみもと歯科医院（歯科・港区），中西歯科医院（歯科・東大阪市），医療法人 清博会 野瀬歯科（歯科・東住吉区），光歯科医院（歯科・東大阪市），樋口歯科クリニック（歯科・東住吉区），医療法人 兵頭歯科医院（歯科・高石市），福原歯科医院（歯科・吹田市），医療法人 藤田歯科医院（歯科・松原市），ふじた歯科クリニック（歯科・西成区），はばら歯科（歯科・西成区），三木歯科医院（歯科・豊中市），南歯科医院（歯科・枚方市），宮本歯科医院（歯科・東成区），森歯科医院（歯科・東住吉区），森内歯科医院（歯科・阿倍野区），やべ歯科クリニック（歯科・八尾市），山内歯科医院（歯科・北区），医療法人 山岡歯科医院（歯科・羽曳野市），横田歯科医院（歯科・天王寺区），吉本歯科（歯科・河内長野市），脇歯科医院（歯科・淀川区），医療法人 貴医会 貴島中央病院（医科・八尾市），医療法人 共立会 たかもと診療所（医科・城東区），医療法人 松尾クリニック（医科・八尾市）

Date of disclosure of the study information

2013

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2013

Year

04

Month

29

Day

Date of IRB

2013

Year

06

Month

25

Day

Anticipated trial start date

2013

Year

07

Month

01

Day

Last follow-up date

2018

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. prospective cohort study
2. We evaluate whether marker for diabetes and halitosis level improve or not.

Registered date

2013

Year

06

Month

12

Day

Last modified on

2021

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012233