Influence of hydrogen containing jelly on periodontal tissue

Not Applicable

• Conditions: 1: Healthy, 2: gingivitis

• Registration Number: JPRN-jRCTs061180055
• Lead Sponsor: Morita Manabu

Brief Summary

Administration of the hydrogen-containing jelly may have a preventive effect on periodontal disease by reducing the production of inflammatory cytokines in the periodontal tissue.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Study Completion: 2020-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study on safety of hydrogen-containing jelly:<br>adverse side effect<br><br>Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:<br>percentage of sites of bleeding on probing

Secondary Outcome Measures

Name	Time	Method
Study on safety of hydrogen-containing jelly:<br>none<br><br>Investigation of effects on periodontal tissue by oral ingestion of hydrogen containing jelly:<br>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