UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043609
Receipt No. R000049622
Scientific Title An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Date of disclosure of the study information 2021/05/01
Last modified on 2021/03/10

* 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 An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Acronym An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title:Acronym An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Region
Japan

Condition
Condition Periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of using an electric toothbrush during periodontal therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcomes are set at Plaque Control Record and the result of saliva test(ammonia). These outcomes will obtain at before and after periodontal therapy.
Key secondary outcomes Secondary outcomes are set at periodontal condition (the percentage of probing depth deeper than 4mm, BOP, PISA) and results of saliva test (bacterial count, acidity, buffering capacity, WBC, protein).These outcomes will obtain at before and after periodontal therapy.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Participants assigned to use an electric tooth brush use an electric tooth blush (Hypersonic pro) during experimental period.
Interventions/Control_2 Participants assigned to use a hand tooth brush use a hand tooth blush (CURAPROX CS5460) during experimental period.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who come to the Department of Endodontics at Tohoku University Hospital, have at least one periodontal pocket of 4 mm or deeper in the periodontal examination.
Key exclusion criteria People who are judged to have difficulty in using an electric toothbrush and to have difficulty in participating in the study due to psychosis or psychiatric symptoms.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Saito
Organization Tohoku University Graduate School of Dentistry
Division name Conservative Dentistry
Zip code 980-8575
Address 4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL 022-717-8343
Email mssaito@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Saito
Organization Tohoku University Graduate School of Dentistry
Division name Conservative Dentistry
Zip code 980-8575
Address 4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL 022-717-8343
Homepage URL
Email mssaito@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Fibermedicine
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 Tohoku University Graduate School of Dentistry, Research Ethics Committee
Address 4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
Tel 022-717-8343
Email mssaito@dent.tohoku.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
2021 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 13 Day
Last modified on
2021 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.