Unique ID issued by UMIN | UMIN000025706 |
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Receipt number | R000029577 |
Scientific Title | Effects of periodontitis treatment on oral bacteria and glucose metabolism |
Date of disclosure of the study information | 2017/10/24 |
Last modified on | 2019/07/23 15:41:10 |
Effects of periodontitis treatment on oral bacteria and glucose metabolism
KOS
Effects of periodontitis treatment on oral bacteria and glucose metabolism
KOS
Japan |
Diabetes mellitus and Periodontitis
Endocrinology and Metabolism | Dental medicine |
Others
NO
To investigate effects of treatment of periodontitis on glucose metabolism
Efficacy
Confirmatory
Not applicable
More than 25% of patients whose HbA1c level decreases 0.5% or more after the final treatment (3 months later), compared to that of the basal level.
HbA1c level is compared to that of historical control (past 3 months changes before the treatment). The other parameters (fasting blood sugar, insulin, HOMA-IR, blood pressure, lipids, liver function, urinary protein, changes of the number and species of oral bacteria, gingival index score, gingival bleeding, CRP, IL-6, and TNFalpha) are compared to those of the basal level.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Treatment of periodontitis
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Under treatment for Diabetes Mellitus type 2, or diagnosed by 75g OGTT.
2) Age on the agreement is within 20-80 yeas-old.
3) Data within 60 days fulfill the criteria below:
HbA1c>=7.0% (if <70 years-old)
HbA1c>=8.0% (if >=70 years-old)
4) Presence of periodontitis
5) Participants give their written consent to join this study.
1) The number of residual teeth is <12.
2) Received oral therapy within past 3 months.
3) Undergoing insulin therapy.
4) Changed abruptly in HbA1c level >=2% within past 3 months.
5) Current morbidity with acute infection, malignant disease or dementia.
6) Past history of hypersensitivity against Tetracycline antibiotics.
7) Past history of shock against the component of Amoxicillin capsules.
8) Past history of hypersensitivity against the component of Amoxicillin capsules or Penicillin antibiotics.
9) Infected by Infectious mononucleosis.
37
1st name | Shozo |
Middle name | |
Last name | Yano |
Shimane University Faculty of Medicine
Department of Laboratory Medicine
693-8501
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
0853-20-2312
syano@med.shimane-u.ac.jp
1st name | Tomii |
Middle name | |
Last name | Yuko |
Shimane University Faculty of Medicine
Clinical Research Center
693-8501
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
0853-20-2515
kenkyu@med.shimane-u.ac.jp
Shimane University Faculty of Medicine
Shimane University Faculty of Medicine
Self funding
None
None
Shimane University IRB
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
0853-20-2515
kenkyu@med.shimane-u.ac.jp
NO
公立邑智病院(島根県)/Ohchi Hospital (Shimane prefecture)
2017 | Year | 10 | Month | 24 | Day |
Unpublished
24
No longer recruiting
2016 | Year | 11 | Month | 07 | Day |
2016 | Year | 12 | Month | 26 | Day |
2017 | Year | 02 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 01 | Month | 17 | Day |
2019 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029577
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