Influence of hydrogen containing jelly on periodontal tissue

JRCT ID: jRCTs061180055

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: 1: Healthy, 2: gingivitis
• Date of first enrollment: 17/05/2019
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Study on safety of hydrogen-containing jelly:
Hydrogen-containing jelly is swallowed three times a day (after every meal) for 14 consecutive days.

Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:
Hydrogen-containing jelly group: Hydrogen-containing jelly is swallowed three times a day (after every meal) for 14 consecutive days.
Hydrogen-free jelly (placebo) group: Hydrogen-free jelly (placebo) is swallowed three times a day (after every meal) for 14 consecutive days.

Outcome(s)

Primary Outcome

Study on safety of hydrogen-containing jelly:
adverse side effect

Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:
percentage of sites of bleeding on probing

Secondary Outcome

Study on safety of hydrogen-containing jelly:
none

Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:
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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Both

Include criteria

Study on safety of hydrogen-containing jelly:
1. Healthy persons over 20 years old

Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:
1. Persons with gingival inflammation with more than 20% of sites of bleeding on probing
2. Persons 20 to 39 years old

Exclude criteria

Study on safety of hydrogen-containing jelly:
1. Persons who drink hydrogen water regularly
2. Persons who have gelatin allergy
3. Persons who have difficulty in swallowing
4. Women who are pregnant or are likely to become pregnant
5. Lactating women

Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:
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
5. Smoker
6. Women who are pregnant or are likely to become pregnant
7. Lactating women

Related Information

• Primary Sponsor: Morita Manabu
• Source(s) of Monetary Support: Shinryo Corporation