Effect of hydrogen-containing jelly on periodontal tissue

JRCT ID: jRCTs061230042

Registered date:02/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Periodontitis
• Date of first enrollment: 05/08/2023
• Target sample size: 70
• 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
• 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
• 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
• Secondary Sponsor: Shinichi Tokuno,Eiji Takayama
• Source(s) of Monetary Support: Shinryo Corporation