![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001690 |
Receipt No. | R000002040 |
Scientific Title | Influence of maternal xylitol consumption from pregnancy on mother-child transmission of cariogenic bacteria and caries occurrence of the infants. |
Date of disclosure of the study information | 2009/02/10 |
Last modified on | 2012/04/27 |
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 |
|
Condition | ||
Condition | dental caries | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 | |
Registered date | File name |
Research case data | |
Registered date | File name |