UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008582 |
|---|---|
| Receipt number | R000010079 |
| Scientific Title | Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2019/02/04 10:51:09 |
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Basic information
Public title
Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis
Acronym
Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis
Scientific Title
Discussion regarding the correlation between periodontal disease and the blood sugar level/arteriosclerosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Setsuko Moriyasu |
Organization
Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Division name
Dentistry
Zip code
Address
94 Choushouji Monzen-chou Sakyou-ku Kyouto city
TEL
075-708-2115
moriyasu@clinic-moriyasu.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Setsuko Moriyasu |
Organization
Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Division name
Dentistry
Zip code
Address
94 Choushouji Monzen-chou Sakyou-ku Kyouto city
TEL
075-708-2115
Homepage URL
moriyasu@clinic-moriyasu.com
Sponsor or person
Institute
Moriyasu Clinic of Dentistry/Internal Medicine/Dermatology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010079
