UMIN-CTR Clinical Trial

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009497