UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effects on dental caries during orthodontic treatment using dental caries prevention program
Acronym	Effects of dental caries prevention program
Scientific Title	Preventive effects on dental caries during orthodontic treatment using dental caries prevention program
Scientific Title:Acronym	Effects of dental caries prevention program
Region	Japan

Condition
Condition	Dental caries (CO,C1,C2)
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As dental caries risks increasing during orthodontic treatment, we want to reduce dental caries risks during that period
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of dental caries infection rate and demineralization depth preoperative and postoperative
Key secondary outcomes

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	Prevention
Type of intervention	Medicine Device,equipment Behavior,custom
Interventions/Control_1	Inspection of bacterial activity using cariscreen(Yoshida). Using fluoride mouth wash. Instruction of brushing habits and tools to use
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	20 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects in this study are healthy minors who is seeing orthodontic dental or scheduled to be consulted and has no history of other systemic diseases.
Key exclusion criteria	Adult patients and minors who has history of systemic diseases are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Tagami
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences
Division name	Cariology and Operative Dentistry
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-5483
Email	tagami.ope@tmd.ac.jp

Public contact
Name of contact person	1st name Keiichi Middle name Last name Hosaka
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Ora
Division name	Cariology and Operative Dentistry
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-5483
Homepage URL
Email	keiichihosaka@gmail.com

Sponsor
Institute	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences Cariology and Operative Dentistry
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences Cariology and Operative Dentistry
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	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Oral Health Sciences, Cariology and Operative Dentistry
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel	03-5803-5483
Email	060371ds@gmail.com

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	2018 Year 06 Month 18 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	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 18 Day
Date of IRB	2018 Year 10 Month 12 Day
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 18 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037671