UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033592 |
|---|---|
| Receipt number | 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 09:57:23 |
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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
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
mmorita@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038311
