UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis
Title of the study (Brief title)	Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis
Region	Japan

Condition
Condition	Periodontal Disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we will measure the blood sugar level and arteriosclerosis index before and after treatment in patients with periodontal disease,and compare the values to investigate the effects of periodontal treatment.Thus,it will be clarified that the start of thorough treatment in the initial phase of periodontal disease reduces arteriosclerosis and blood sugar level even at practitioner's levels, contributing to the prevention of arteriosclerotic lifestyle-related disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will select patients with moderate to severe periodontal disease in our clinic. Blood will be collected before periondontal treatment to measure the blood sugar level and arteriosclerosis index.Examination parameters include the blood sugar level,Hba1c,IL-6,high-sensitivityCRP,and1.5HG. The arteriosclerosis index will be measured using a VaSera VS-1500 blood pressure/pulse wave-testing system(Fukuda Electron Co.,Ltd). Periodontal disease will be evaluated as follows: The depth of pocket(gingival groove)is measured using a probe,and the presence or absence of hemorrhage is evaluated.Furthermore,the degree of tooth fluctuation is assessed in 4 grades.In addition,the grade of bone resorption is visually evaluated using X-ray films.The results of these examinations are written on a sheet for measurement,and the condition of periodontal disease is comprehensively evaluated.For assessment before and after periodontal treatment,the total nummber of all tooth pockets/number of teeth is used. After periodontal treatment is performed,the blood sugar level and arterioaclerosis index will be additionally measured, and compared with the preoperative values. A non-house intermist of our clinic,Dr.Koshiba(Professor,Depratment of Disaster Medicine Support,Fukushima Prefectural Medical University)will make scientific comments from an MD's prespective.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with moderate to severe periodontal disease
Key exclusion criteria	When it is difficult to obtain informed consent from subjects
Target sample size	60

Research contact person
Name of lead principal investigator	Setsuko Moriyasu
Organization	Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Division name	Dentistry
Address	94 Choushouji Monzen-chou Sakyou-ku Kyouto city
TEL	075-708-2115
Email	moriyasu@clinic-moriyasu.com

Public contact
Name of contact person	Setsuko Moriyasu
Organization	Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Division name	Dentistry
Address	94 Choushouji Monzen-chou Sakyou-ku Kyouto city
TEL	075-708-2115
Homepage URL
Email	moriyasu@clinic-moriyasu.com

Sponsor
Institute	Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Institute
Department

Funding Source
Organization	Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will measure the blood sugar level and arteroiaclerosis index before and after treatment in patients with periodontal disease,and compare the values to investigate the effect of periodontal treatment.

Management information
Registered date	2012 Year 07 Month 31 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010079