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
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
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
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
