Unique ID issued by UMIN | UMIN000032052 |
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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 | 2023/08/25 21:43:03 |
Role of oral care in the remission phase of inflammatory bowel disease: a study focusing on oral bacteria and intestinal flora
orogutbiomics on improved oral care
Role of oral care in the remission phase of inflammatory bowel disease: a study focusing on oral bacteria and intestinal flora
orogutbiomics on improved oral care
Japan |
Inflammatory Bowel Disease (IBD) and Oral Infectious Disease
Gastroenterology | Dental medicine |
Others
NO
Whether improved oral care can bring changes in the intestinal flora of the IBD patients.
Efficacy
Exploratory
Pragmatic
Not applicable
Qualitative and quantitative changes of oral pathogens in intestinal flora.
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).
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Behavior,custom |
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.
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.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
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.
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.
45
1st name | |
Middle name | |
Last name | Hanada Nobuhiro |
Tsurumi University
School of Dental Medicine
2-1-3 Tsurumi, Yokohama, Japan
045-580-8461
hanada-n@tsurumi-u.ac.jp
1st name | |
Middle name | |
Last name | Matin Khairul / Otsuka Ryoko |
Tsurumi University
School of Dental Medicine
2-1-3 Tsurumi, Yokohama, Japan
045-580-8462
matin-k@tsurumi-u.ac.jp
Tsurumi University School of Dental Medicine, Department of Translational Research
Japan Society for the Promotion of Science
Japanese Governmental office
JAPAN
Tokyo Medical and Dental University
NO
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)
2018 | Year | 04 | Month | 02 | Day |
Unpublished
Completed
2017 | Year | 06 | Month | 14 | Day |
2017 | Year | 07 | Month | 25 | Day |
2018 | Year | 05 | Month | 10 | Day |
2023 | Year | 07 | Month | 25 | Day |
2018 | Year | 04 | Month | 01 | Day |
2023 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035917
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