UMIN-CTR Clinical Trial

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
Email	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
Email	matayoshi.saaya.dent@osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055827