UMIN-CTR Clinical Trial

Basic information
Public title	Survey on the prevention of oral diseases
Acronym	Survey on the prevention of oral diseases
Scientific Title	Survey on the prevention of oral diseases
Scientific Title:Acronym	Survey on the prevention of oral diseases
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years national medical expenses, due to the increase by 1 billion each year, there is a growing importance of prevention. In, which is also touted the importance of prevention in the dental field, workers who are busy in day-to-day duties, dental treatment is tend to become secondary. Therefore when the prominent symptoms in the oral cavity (pain, upset, etc.) is not from appearing without visit to the dentist's office, a result there is a case in which saving the tooth becomes impossible. In addition the treatment is hard to do even early detection and early treatment of the disease for retention rate is also low of regular checkups after the end (maintenance). Therefore, in the present study examines the awareness and need for dental treatment of people falls on working people, to establish the system and educational activities to improve the participation rate of regular checkups, it aims to clarify the role as a regional primary care physician to.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Three times every six months the state to caries, periodontal disease from the oral cavity in the examination for the first time by the intra-oral examination.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Use the disposable paper tray, the probe and the mirror tweezers probe rubber gloves, perform the intra-oral examination. Also make the toothpaste guidance using a hand mirror, toothbrush. The period of intervention and two years, frequency and once in six months.
Interventions/Control_2	Use the disposable paper tray, the probe and the mirror tweezers probe rubber gloves, perform the intra-oral examination.The duration of the intervention shall be two years and the frequency shall be once every six months. This group is used as a control group.
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	15 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Workers in Osaka Prefecture belonging to the service industry, transportation industry, manufacturing industry, small businesses and individual shops among those who are not visiting dental clinics
Key exclusion criteria	Persons who are visiting a dental office, people with mental illness, people with movement disorders
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Okinori Middle name Last name Shikura
Organization	Matsumoto Dental University Institute /Dentistry independent Graduate School
Division name	hin oral function control Laboratory /Biological regulation control studies
Zip code	399-0781
Address	Nagano Prefecture Shiojiri Hirookagobara 1780
TEL	080-8923-9797
Email	o.shikura@outlook.jp

Public contact
Name of contact person	1st name Okinori Middle name Last name Shikura
Organization	Matsumoto Dental University Institute /Dentistry independent Graduate School
Division name	Chin oral function control Laboratory /Biological regulation control studies
Zip code	399-0781
Address	Nagano Prefecture Shiojiri Hirookagobara 1780
TEL	080-8923-9797
Homepage URL
Email	o.shikura@outlook.jp

Sponsor
Institute	Matsumoto Dental University Institute /Dentistry independent Graduate School
Institute
Department

Funding Source
Organization	Matsumoto Dental University Institute /Dentistry independent Graduate School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Matsumoto Dental University Institute /Dentistry independent Graduate School
Address	Nagano Prefecture Shiojiri Hirookagobara 1780
Tel	0263-51-2188
Email	info_kakenhi@po.mdu.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	2016 Year 12 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	21
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	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 09 Month 30 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 10 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	2016 Year 11 Month 09 Day
Last modified on	2020 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028506