UMIN-CTR Clinical Trial

Basic information
Public title	Influence of maternal xylitol consumption from pregnancy on mother-child transmission of cariogenic bacteria and caries occurrence of the infants.
Acronym	Xylitol mother-child study
Scientific Title	Influence of maternal xylitol consumption from pregnancy on mother-child transmission of cariogenic bacteria and caries occurrence of the infants.
Scientific Title:Acronym	Xylitol mother-child study
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to evaluate the effect of maternal consumption of xylitol chewing gum via an early intervention period on mother-child transmission of MS among Japanese population. As a secondary analysis, MS levels of the mothers during the intervention and after cessation were assessed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	MS colonization was assessed the presence of bacterial growth on the strip and site strip in the children aged 6, 9, 12, 18, and 24 months (Dentocult SM).
Key secondary outcomes	Salivery MS levels of the mothers during intervention for 13 months and as well as for 15 months after cessation of the intervention(Dentocult SM).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The mothers in Xyl group received basic prevention such as oral hygiene instructions and professional tooth cleaning at 6th month of pregnancy. In Xyl group, maternal gum chewing started at 6th month of the pregnancy and terminated 13 mos later when their children were 9 mos of age. Children in both groups had never been intervened at all.
Interventions/Control_2	The mothers in Control group received basic prevention such as oral hygiene instructions and professional tooth cleaning at 6th month of pregnancy (the same way as Xyl group).
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	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women who visited Miyake Obstetrics and Gynecology Clinic were screened for their salivary MS levels that were estimated using Dentocult® SM Strip Mutans (Orion Diagnostica, Espoo, Finland) following a standard procedure. Of these, the pregnant women who showed high salivary MS levels (SM score>=2) were invited to participate in the study.
Key exclusion criteria	Individuals with a history of regular antibiotics medication or GI problem.
Target sample size	92

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukie Nakai
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Behavioral Pediatric Dentistry
Zip code
Address	2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8525, Japan
TEL	086-235-6717
Email

Public contact
Name of contact person	1st name Middle name Last name Yukie Nakai
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Behavioral Pediatric Dentistry
Zip code
Address	2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8525, Japan
TEL	086-235-6717
Homepage URL
Email

Sponsor
Institute	Dept. of Behavioral Pediatric Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (Grant-in-Aid for Scientific research)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
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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	2009 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2003 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date	2003 Year 12 Month 01 Day
Last follow-up date	2007 Year 09 Month 01 Day
Date of closure to data entry	2008 Year 03 Month 01 Day
Date trial data considered complete	2008 Year 06 Month 01 Day
Date analysis concluded	2008 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2009 Year 02 Month 06 Day
Last modified on	2012 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002040

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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