JRCT ID: jRCTs061230042
Registered date:02/08/2023
Effect of hydrogen-containing jelly on periodontal tissue
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Periodontitis |
Date of first enrollment | 05/08/2023 |
Target sample size | 70 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Hydrogen-containing jelly group: Hydrogen-containing jelly is swallowed without chewing three times a day (morning, noon, night) for 28 consecutive days. Hydrogen-free jelly (placebo) group: Hydrogen-free jelly (placebo) is swallowed without chewing three times a day (morning, noon, night) for 28 consecutive days. |
Outcome(s)
Primary Outcome | Percentage of sites of bleeding on probing |
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Secondary Outcome | 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, lactate dehydrogenase of unstimulated saliva, cytokines (IL-1 beta, IL-6, IL-10, IL-17, and TNF-alpha) levels of gingival crevicular fluid |
Key inclusion & exclusion criteria
Age minimum | >= 70age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Persons over 70 years old 2. Persons who have more than 10 teeth 3. Persons with periodontitis |
Exclude criteria | 1. Persons who took antibiotics, anti-inflammatory drugs, antiallergic drugs within the past two weeks 2. Persons who drink hydrogen water regularly 3. Persons who have gelatin allergy 4. Persons who have difficulty in swallowing |
Related Information
Primary Sponsor | Takayuki Maruyama |
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Secondary Sponsor | Shinichi Tokuno,Eiji Takayama |
Source(s) of Monetary Support | Shinryo Corporation |
Secondary ID(s) |
Contact
Public contact | |
Name | Maruyama Takayuki |
Address | 2-5-1, Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558 |
Telephone | +81-86-235-6712 |
t-maru@md.okayama-u.ac.jp | |
Affiliation | Okayama University Hospital |
Scientific contact | |
Name | Maruyama Takayuki |
Address | 2-5-1, Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558 |
Telephone | +81-86-235-6712 |
t-maru@md.okayama-u.ac.jp | |
Affiliation | Okayama University Hospital |