UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025706
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of periodontitis treatment on oral bacteria and glucose metabolism
Acronym KOS
Scientific Title Effects of periodontitis treatment on oral bacteria and glucose metabolism
Scientific Title:Acronym KOS
Region
Japan

Condition
Condition Diabetes mellitus and Periodontitis
Classification by specialty
Endocrinology and Metabolism Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of treatment of periodontitis on glucose metabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Treatment of periodontitis
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 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.

Key exclusion criteria 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.
Target sample size 37

Research contact person
Name of lead principal investigator
1st name Shozo
Middle name
Last name Yano
Organization Shimane University Faculty of Medicine
Division name Department of Laboratory Medicine
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2312
Email syano@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Tomii
Middle name
Last name Yuko
Organization Shimane University Faculty of Medicine
Division name Clinical Research Center
Zip code 693-8501
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2515
Homepage URL
Email kenkyu@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Shimane University IRB
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel 0853-20-2515
Email kenkyu@med.shimane-u.ac.jp

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 公立邑智病院(島根県)/Ohchi Hospital (Shimane prefecture)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 24 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 24
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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
2016 Year 12 Month 26 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 17 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.