UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049454 |
|---|---|
| Receipt number | R000055827 |
| Scientific Title | Effects of mouthwash on periodontopathogenic bacterial species and diabetes markers in patients complicated with diabetes mellitus |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2022/11/08 09:18:36 |
* 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 mouthwash on periodontal pathogens and diabetes markers in patients complicated with diabetes mellitus
Acronym
Effects of mouthwash on periodontal pathogens and diabetes markers in patients complicated with diabetes mellitus
Scientific Title
Effects of mouthwash on periodontopathogenic bacterial species and diabetes markers in patients complicated with diabetes mellitus
Scientific Title:Acronym
Effects of mouthwash on periodontopathogenic bacterial species and diabetes markers in patients complicated with diabetes mellitus
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of mouthwash on periodontopahogenic bacteria in patients complicated with diabetes mellitus and its effect on diabetic markers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of periodontalpathogenic bacterial species
Key secondary outcomes
diabetic markers; blood sugar level, hemoglobin A1c
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Gurgling with water for 6 months before gurgling with mouthwash for 6 months.
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
Persons diagnosed with diabetes mellitus
Key exclusion criteria
Persons with dementia
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Saaya |
| Middle name | |
| Last name | Matayoshi |
Organization
Osaka University Graduate School of Dentistry
Division name
Joint Research Laboratory of Science for Oral and Systemic Connection
Zip code
5650871
Address
1-8, Yamada-oka, Suita, Osaka
TEL
0668792962
matayoshi.saaya.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Saaya |
| Middle name | |
| Last name | Matayoshi |
Organization
Osaka University Graduate School of Dentistry
Division name
Joint Research Laboratory of Science for Oral and Systemic Connection
Zip code
5650871
Address
1-8, Yamada-oka, Suita, Osaka
TEL
0668792962
Homepage URL
matayoshi.saaya.dent@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Weltec Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board and ethics committee of Osaka University Dental Hospital
Address
1-8, Yamada-oka, Suita, Osaka
Tel
0668795111
si-soumu-syomu@office.osaka-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 30 | 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
280
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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055827
