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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032052
Receipt No. 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 2018/04/01

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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).

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
Middle name
Last name Hanada Nobuhiro
Organization Tsurumi University
Division name School of Dental Medicine
Zip code
Address 2-1-3 Tsurumi, Yokohama, Japan
TEL 045-580-8461
Email hanada-n@tsurumi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Matin Khairul / Otsuka Ryoko
Organization Tsurumi University
Division name School of Dental Medicine
Zip code
Address 2-1-3 Tsurumi, Yokohama, Japan
TEL 045-580-8462
Homepage URL
Email matin-k@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University School of Dental Medicine, Department of Translational Research
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Tokyo Medical and Dental University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)、東京医科歯科大学医学部附属病院(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)、がもう歯科医院(東京都)
Tsurumi University Dental Hospital (Kanagawa), Tokyo Medical and Dental University (TMDU) Medical Hospital (Tokyo), Kioicho Plaza Clinic (Tokyo), Gamo Dental 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 10 Day
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
2018 Year 04 Month 01 Day
Last modified on
2018 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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