UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032052 |
|---|---|
| Receipt number | R000035917 |
| Scientific Title | Role of oral care in the remission phase of inflammatory bowel disease: a study focusing on oral bacteria and intestinal flora |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2025/10/18 16:07:06 |
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Basic information
Public title
Role of oral care in the remission phase of inflammatory bowel disease: a study focusing on oral bacteria and intestinal flora
Acronym
orogutbiomics on improved oral care
Scientific Title
Role of oral care in the remission phase of inflammatory bowel disease: a study focusing on oral bacteria and intestinal flora
Scientific Title:Acronym
orogutbiomics on improved oral care
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease (IBD) and Oral Infectious Disease
Classification by specialty
| Gastroenterology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether improved oral care can bring changes in the intestinal flora of the IBD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative and quantitative changes of oral pathogens in intestinal flora.
Key secondary outcomes
Qualitative and quantitative changes of oral pathogens in the oral cavity with an improvement of periodontal pocket depths, bleeding on probing; BOP, salivary secretion rate, hematological indices (general and specific, e.g.; albumin, CRP, hemoglobin levels), salivary calprotectin, fecal calprotectin.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
IBD Volunteers will receive improved disinfection treatment and advice (including mechanical tooth surface and periodontal pocket cleaning) and then will follow improved home care with a super-oxidized water (SOW) using a liquid-carrier type custom try (lc-3DS) twice daily for 12 weeks in addition to usual home care.
Interventions/Control_2
Healthy volunteers will receive improved disinfection treatment and advice (including mechanical tooth surface and periodontal pocket cleaning) and then will follow improved home care with a super-oxidized water (SOW) using a liquid-carrier type custom try (lc-3DS) twice daily for 12 weeks in addition to usual home care.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Volunteers not having severe caries and periodontal disease.
2 Volunteers not having history of any kind of gastrointestinal surgery.
3 Volunteers currently not receiving treatment of any chronic disease; however, volunteers who are taking medicinal treatment for stabilizing remission condition can take part.
4 Volunteers have not received/ receiving any kind of fecal (microbiota) transplantation.
5 Volunteers have not taken any antibiotics 3 months prior to the start of the study.
6 Volunteers who are not participating in other clinical study.
7 Volunteers who agree to participate willingly.
Key exclusion criteria
1 Volunteers having a habit of smoking.
2 Volunteers who are pregnant or may get pregnant.
3 IBD Volunteers who will have an altered dose of medicine or receive new medicine in 3 months before that the start of the study.
4 Volunteers have taken any antibiotics 3 months prior to the start of the study.
5 Volunteers have received/ receiving any kind of fecal (microbiota) transplantation.
6 Volunteers need treatment for any other disease as priority.
7 Volunteers taking part in any other clinical study not relating to this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hanada |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Yokohama, Japan
TEL
045-580-8415
hanada-n@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Otsuka |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Yokohama, Japan
TEL
045-580-8415
Homepage URL
otsuka-r@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University School of Dental Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Institute of Science Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tsurumi University School of Dental Medicine
Address
2-1-3 Tsurumi, Yokohama, Japan
Tel
045-581-1001
kyoken@tsurumi-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
鶴見大学歯学部附属病院（神奈川県）、東京科学大学病院(東京都)、医療法人社団研裕会紀尾井町プラザクリニック（東京都）、
Tsurumi University Dental Hospital (Kanagawa), Institute of Science Tokyo University Hospital (Tokyo), Kioicho Plaza Clinic (Tokyo),
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035917
