UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Natural initialcaries caries lesions remineralization by chewing sugar-free gum containing bio-available fluoride
Title of the study (Brief title)	Initial caries lesions remineralization by chewing gum
Region	Japan

Condition
Condition	initial caries lesion
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of chewing gum containing fluoride on natural initial caries lesions remineralization
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	surface property of initial caries lesions are evaluated by ICDAS score
Key secondary outcomes	lesion depth of initial caries are evaluated using OCT images

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	daily chewing gum containing bioaveialble calcium and fluoride over 3 months
Interventions/Control_2	daily chewing gum containing bioaveialble fluoride over 3 months
Interventions/Control_3	daily chewing placebo gum over 3 months
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	Not applicable
Gender	Male and Female
Key inclusion criteria	For inclusion in the study, the subjects were required to have at least one WSL, with an ICDAS score of 2 or 1
Key exclusion criteria	Exclusion criteria included smoking, evidence of poor oral health including periodontal disease, recent professional fluoride therapy (<2 weeks), uptake of fluoridated water or any medication that could affect oral flora, and pregnancy.
Target sample size	50

Research contact person
Name of lead principal investigator	Tagami Junji
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Cariology and Operative Dentistry
Address	5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL	03-5803-5483
Email	tagami.ope@tmd.ac.jp

Public contact
Name of contact person	Kitasako Yuichi
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Cariology and Operative Dentistry
Address	5-45 Yushima 1-chome, Bunkyo-ku, Tokyo
TEL	03-3813-6111
Homepage URL
Email	kitasako.ope@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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 02 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2018 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024379