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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035472
Receipt No. R000040407
Official scientific title of the study Diabetes improvement effect by full mouth SRP combined with antibiotics for diabetes patient with periodontal disease.
Date of disclosure of the study information 2019/01/10
Last modified on 2019/01/07

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Basic information
Official scientific title of the study Diabetes improvement effect by full mouth SRP combined with antibiotics for diabetes patient with periodontal disease.
Title of the study (Brief title) The effects of periodontal pharmacotherapy on diabetes.
Region
Japan

Condition
Condition chronic periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the improvement of periodontal disease and diabetes mellitus by the periodontal pharmacotherapy for the diabetic patient with periodontal disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PISA (Periodontal inflamed surface area)
time of assesment after 1, 3, 6 month, 1, 2 year from the start of the study.
Key secondary outcomes periodontal pocket depth, BOP, HbA1c, hs-CRP, IL-6, MCP-1

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Azithromysin
duration of administration: 1time/day, for 3 days
Dosage: 500mg/time
Interventions/Control_2 Full mouth SRP
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria *Age 35 years old or older
* The residual teeth more than 10 teeth
*Periodontal pockets 4mm or more have more than 30%
Key exclusion criteria *Person with a serious systemic disease except the diabetes mellitus
*The allergy to a macrolide derivative antimicrobial agent
*Smokers
*Person who dentist judged inadequate
Target sample size 120

Research contact person
Name of lead principal investigator Kazuhiro Gomi
Organization Tsurumi University, School of Dental Medicine
Division name Department of Periodontology
Address 2-1-3 Tsuurmi, Tsurumi-ku, Yokohama
TEL 045-580-8431
Email gomi-k@tsurumi-u.ac.jp

Public contact
Name of contact person Kazuhiro Gomi
Organization Tsurumi University, School of Dental Medicine
Division name Department of Periodontology
Address 2-1-3 Tsuurmi, Tsurumi-ku, Yokohama
TEL 045-580-8431
Homepage URL
Email gomi-k@tsurumi-u.ac.jp

Sponsor
Institute Department of Periodontology, School of Dental Medicine, Tsurumi University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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
2019 Year 01 Month 10 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
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

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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