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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033592
Receipt No. R000038311
Scientific Title Influence of oral ingestion of hydrogen containing jelly on periodontal tissue
Date of disclosure of the study information 2018/09/18
Last modified on 2019/08/02

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Basic information
Public title Influence of oral ingestion of hydrogen containing jelly on periodontal tissue
Acronym Influence of oral ingestion of hydrogen containing jelly on periodontal tissue
Scientific Title Influence of oral ingestion of hydrogen containing jelly on periodontal tissue
Scientific Title:Acronym Influence of oral ingestion of hydrogen containing jelly on periodontal tissue
Region
Japan

Condition
Condition gingivitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of ingestion of hydrogen containing jelly on periodontal tissue.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes percentage of sites of bleeding on probing
Key secondary outcomes probing pocket depth
clinical attachement level
periodontal inflamed surface area: PISA
plaque control record: PCR
oxidative stress (d-ROMs) and antioxidant capacity (OXY-adsorbent test) of serum
oxidative stress (8-OHdG) and lactate dehydrogenase of unstimulated saliva
cytokines (IL-1 beta, IL-6, IL-10, IL-17, and TNF-alpha) levels of gingival crevicular fluid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Hydrogen-containing jelly is swallowed after chewing for 10 seconds three times a day (after every meal) for 14 consecutive days.
Interventions/Control_2 Hydrogen-free jelly is swallowed after chewing for 10 seconds three times a day (after every meal) for 14 consecutive days.
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

Not applicable
Gender Male and Female
Key inclusion criteria Persons with inflammation in the maxillary anterior periodontal tissue
Key exclusion criteria Persons who took antibiotics, anti-inflammatory drugs, antiallergic drugs within the past two weeks
Smoker
Women who are pregnant or are likely to become pregnant
Lactating women
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6712
Email mmorita@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6712
Homepage URL
Email mmorita@md.okayama-u.ac.jp

Sponsor
Institute Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Shinryo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of oral biochemistry, Asahi University Graduate School of Dentistry.
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 岡山大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 18 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 Terminated
Date of protocol fixation
2018 Year 07 Month 19 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2018 Year 09 Month 19 Day
Last follow-up date
2022 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 08 Month 01 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038311

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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