UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026233
Receipt number R000030134
Scientific Title A study of the effects on oral bacteria with D-Tagatose chewing gum
Date of disclosure of the study information 2017/02/20
Last modified on 2020/08/31 10:55:19

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name