UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects on oral bacteria with D-Tagatose chewing gum
Acronym	A study with D-Tagatose chewing gum
Scientific Title	A study of the effects on oral bacteria with D-Tagatose chewing gum
Scientific Title:Acronym	A study with D-Tagatose chewing gum
Region	Japan

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

Objectives
Narrative objectives1	In order to verify the effect of D-tagatose on oral bacteria, measure changes in oral bacteria with chewing D-tagatose gum or D-tagatose and xylitol mixing gum.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	About 10 ml of saliva is collected before starting the gum test and collected one week later periodically until the fourth week. Dilute saliva is seeded on BHI and Mitis Salivarious Bacitracin Agar (MSB) agar plates and bacterial counts are measured.
Key secondary outcomes	Evaluate bacterial counts of Streptococcus mutans or Lactobacillus with Dentocult SM or Dentocult LB kit.

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	D-tagatose gum The weight of one gum tablet is 1.5 g, used three times after each meals, chew 2 tables to 1 time for 10 minutes
Interventions/Control_2	Xylitol gum The weight of one gum tablet is 1.5 g, used three times after each meals, chew 2 tables to 1 time for 10 minutes
Interventions/Control_3	D-tagatose and Xylitol mixing gum The weight of one gum tablet is 1.5 g, used three times after each meals, chew 2 tables to 1 time for 10 minutes
Interventions/Control_4	Multitose gum The weight of one gum tablet is 1.5 g, used three times after each meals, chew 2 tables to 1 time for 10 minutes
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) High dental caries active person by saliva buffering ability test or intraoral examination 2) Person who can agree with writing on participation of this exam
Key exclusion criteria	1) Low dental caries active person by saliva buffering ability test or intraoral examination 2) Person who cannot agree on participation of this exam even through parents or assistant 3) Antibiotics or anticancer drug, patient who was receiving the same treatment during radiation therapy treatment or within 1 year 4) Those judged unsuitable as subjects 5) Can not bite 3 g (2 tables) of gum for more than 10 minutes 6) Use of removable dentures, use of orthodontic treatment equipment 7) Salivary gland disease, xerostomia, renal dysfunction, abnormal liver function 8) Children under 6 years of age
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Ogawa
Organization	Kagawa University Hospital
Division name	Department of oral and maxillofacial surgery
Zip code	761-0793
Address	1750-1 Ikenobe, MIki-cho, Kita-gun, Kagawa
TEL	087-891-2227
Email	ogawata@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Ogawa
Organization	Faculty of Medicine, Kagawa University
Division name	Department of oral and maxillofacial surgery
Zip code	761-0793
Address	1750-1 Ikenobe, MIki-cho, Kita-gun, Kagawa
TEL	087-891-2227
Homepage URL
Email	ogawata@med.kagawa-u.ac.jp

Sponsor
Institute	Department of oral and maxillofacial surgery, Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Faculty of Medicine, Kagawa University
Address	1750-1 Ikenobe, MIki-cho, Kita-gun, Kagawa
Tel	087-898-5111
Email	chosa@med.kagawa-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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 20 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	No longer recruiting
Date of protocol fixation	2015 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 06 Day
Last follow-up date	2017 Year 05 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	2017 Year 02 Month 20 Day
Last modified on	2020 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030134