UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of clinical usefulness of Prinia Smile, GC
Acronym	Evaluation of clinical usefulness of an electric toothbrush
Scientific Title	Evaluation of clinical usefulness of an electric tooth brush, Prinia Smile, GC
Scientific Title:Acronym	Evaluation of clinical usefulness of an electric tooth brush, Prinia Smile, GC
Region	Japan

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

Objectives
Narrative objectives1	We will check whether PCR (Plaque Control Record) 20%, which is one of the evaluation criteria when treating periodontal disease, can be achieved by TBI(teeth brushing instructiono) with an electric toothbrush.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Check if PCR(Plaque Control Record) 20% was achieved
Key secondary outcomes	Confirm that no adverse events such as pain occurred

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Get periodontal examination before using electric toothbrush
Interventions/Control_2	Fix the frequency of the electric toothbrush used
Interventions/Control_3	Change the frequency of the electric toothbrush used
Interventions/Control_4	Changing the head of the electric toothbrush used
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Age:Patients who are 20 years of age or older when obtaining consent (2)Gender:Any (3)Hospitalization / Outpatient: Outpatient only (4)Periodontal examination:Patients who have been diagnosed as having moderate or more chronic periodontitis or invasive periodontitis as a result of periodontal examination (5)Patients who have received sufficient explanation for participation in this study, and who have fully understood and consented to the document by their own will. (6)Systemic periodontal disease treatment has not been received in the past, or even if it has been received, plaque control is poor and there is a wide range of recurrence sites. (7)There are more than 20 remaining teeth in all jaws. 8)Antibacterial drugs.You have not taken any antibacterial drugs within the past 3 months on the registration date.
Key exclusion criteria	(1)Patients with diabetes that cannot be controlled (2)Patients with severe heart disease (3)Patients with severe liver and renal dysfunction (4)Patients taking antibody drugs or anti-inflammatory drugs for autoimmune diseases (5)Other patients who are deemed inappropriate by the research director
Target sample size	40

Research contact person
Name of lead principal investigator	1st name yamashita Middle name Last name yasunori
Organization	Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University
Division name	Department of Periodontology and Endodontology
Zip code	8528501
Address	1-7-1, sakamoto, nagasaki city, nagasaki prefecture
TEL	095-819-7643
Email	yamachanpon@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name yamashita Middle name Last name yasunori
Organization	Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University
Division name	Department of Periodontology and Endodontology
Zip code	8528501
Address	1-7-1, sakamoto, nagasaki , nagasaki
TEL	095-819-7643
Homepage URL
Email	yamachanpon@nagasaki-u.ac.jp

Sponsor
Institute	Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Department of Periodontology and Endodontology
Institute
Department

Funding Source
Organization	Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Department of Periodontology and Endodontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	nagasaki university
Address	1-7-1, sakamoto, nagsaki, nagasaki
Tel	095-819-7229
Email	gaibushikin@ml.nagasaki-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	長崎大学病院

Other administrative information
Date of disclosure of the study information	2019 Year 10 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
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	2019 Year 10 Month 30 Day
Date of IRB	2019 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 11 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 28 Day
Last modified on	2020 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043774