UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008071
Receipt number R000009497
Scientific Title The study on the effects on atherosclerotic diseases by periodontal treatment
Date of disclosure of the study information 2012/06/01
Last modified on 2021/10/19 13:38:11

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Basic information

Public title

The study on the effects on atherosclerotic diseases by periodontal treatment

Acronym

Relation between atherosclerotic diseases and periodontitis

Scientific Title

The study on the effects on atherosclerotic diseases by periodontal treatment

Scientific Title:Acronym

Relation between atherosclerotic diseases and periodontitis

Region

Japan


Condition

Condition

Periodontitis, Atherosclerosis

Classification by specialty

Cardiology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of relation between periodontal disease and atherosclerosis, and investigation of effect on index of atherosclerosis by periodontal treatment, for lifestyle-related disease patients

Basic objectives2

Others

Basic objectives -Others

Statistic study on relation between periodontal index and atherosclerosis index at early stage examination

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Periodontitis: Periodontal probing depth, Blood IgG antibody titer to periodontal pathogens
Atherosclerosis: Carotid artery Intima - media thickness, Serum lipid, Blood sugar

Key secondary outcomes

Body Mass Index, Creatine phosphokinase, White blood cell, Urine occult blood, Pulse wave velocity, High - sensitivity C - reactive protein, Tumor necrosis factor - alpha, Adiponectin


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

Patients with lifestyle-related disease: one of following criteria
LDL over 140 mg/dl
systolic blood pressure over 140 mmHg
diastolic blood pressure over 90mmHg
fasting blood glucose over 110 mg/dl
glycosylated Hemoglobin A over 5.9 %

Periodontitis patients:following criteria
periodontal probing depth over 4mm at any probing site

Key exclusion criteria

A) acute myocardial infarction (within 6 months)
B) unstable angina
C) severe heart diseases
D) Cardiovascular surgery (within 6 months)
E) cerebrovascular accidents (within 6 months)
F) severe hepatitis or renal disease
G) malignant tumors
H) port control diabetes
I) lipidosis with following conditions
a) nephrotic syndrome
b) hypothyroidism
c) cushing Syndrome
d) secondary hyperlipemia according to other diseases
J) hyperlipemia according to medicine such as steroids
K) perioperative patients
L) patients with poor compliance

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shogo Takashiba

Organization

Okayama University

Division name

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

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 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 Pahophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Phar

Zip code


Address

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

TEL

086-235-6675

Homepage URL

http://www.cc.okayama-u.ac.jp/~perio/bind2/index.html

Email

perio@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



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

関町内科クリニック{東京保険医協会(医科)},きょうどう歯科{東京歯科保険医協会(歯科)},文教通り歯科クリニック{千葉県保険医協会(歯科)},医療法人社団敬天会鶴田クリニック,森元歯科医院,松島歯科医院,しのはら歯科医院,甲斐歯科医院,三咲内科クリニック,フレンド歯科,川村歯科医院,KUMAデンタルクリニック,医療法人社団永研会,原井デンタルオフィス,なかむら医院,ぴあーすクリニック,ごうけ歯科クリニック,ほりうち歯科医院,はしもと歯科クリニック,池田デンタルクリニック,始平堂歯科医院,重城病院,なるかわ歯科医院,KENクリニック,とりうみ歯科クリニック,三上歯科医院,さかえ歯科医院,社団 恵修会 クリニック安田,社団 ペリオ会 目白メディカルロード歯科,練馬総合病院内科,沼口歯科医院,田中デンタルクリニック,さかい歯科医院,稲毛デンタルクリニック,牛込台さこむら内科,牛込神楽坂デンタルオフィス,永研会クリニック,永研会クリニック,松本歯科医院,ポートスクエア柏戸クリニック,柏戸病院内科,平良クリニック,健生クリニック,上総記念病院,熊切歯科医院,大澤歯科医院,ほたるのセントラルクリニック,星野歯科クリニック,おだ歯科クリニック,本田内科医院,たかかぜ歯科,つばさデンタルクリニック,伊藤内科小児科クリニック,ながなわ歯科,小貫歯科医院,天台歯科医院,おおの歯科医院,ほたる野歯科医院,勝田台歯科医院,富谷中央病院,富谷中央病院,富谷中央病院,植村歯科クリニック


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://link.springer.com/article/10.1007%2Fs10266-014-0172-3

Number of participants that the trial has enrolled


Results

There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis.

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

Completed

Date of protocol fixation

2012 Year 05 Month 22 Day

Date of IRB

2012 Year 05 Month 22 Day

Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2015 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 05 Month 31 Day


Other

Other related information

Pilot study has been performed.


Management information

Registered date

2012 Year 05 Month 31 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=R000009497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name