UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035472 |
|---|---|
| Receipt number | R000040407 |
| Scientific Title | 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 | 2024/01/11 09:03:57 |
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Basic information
Public title
Diabetes improvement effect by full mouth SRP combined with antibiotics for diabetes patient with periodontal disease.
Acronym
The effects of periodontal pharmacotherapy on diabetes.
Scientific Title
Diabetes improvement effect by full mouth SRP combined with antibiotics for diabetes patient with periodontal disease.
Scientific Title:Acronym
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
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Gomi |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, YOKOHAMA
TEL
0455808431
gomi-k@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Gomi |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3 Tsuurmi, Tsurumi-ku, Yokohama
TEL
045-580-8431
Homepage URL
gomi-k@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Periodontology, School of Dental Medicine, Tsurumi University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Tsurumi University, School of Dentakmedicine
Address
2-1-3 Tsurumi, Tsurumi-ku, YOKOHAMA
Tel
045-580-8431
fukuoka-m@tsurumi-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
小松病院（静岡県）
杢保クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 10 | 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
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 07 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
