UMIN-CTR Clinical Trial

Basic information
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
Condition	Diabetes Mellitus Periodontal Disease
Classification by specialty	Medicine in general Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 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	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
Other related information	1. prospective cohort study 2. We evaluate whether marker for diabetes and halitosis level improve or not.

Management information
Registered date	2013 Year 06 Month 12 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012233