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Human Application Study to Evaluate the Functionality of a Probiotic Complex Affecting Gum Health

Evaluation of the Functionality of the DM163 and DSR920 Probiotic Affecting Gingival Health: A Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0009762
Enrollment
30
Registered
2024-09-06
Start date
2023-09-12
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Names: Lactobacillus plantarum DSR920 and Lacticaseibacillus rhamnosus DM163. Dosage: Each dose contains 7.5E10 CFU of L. plantarum DSR920 and 2.5E10 CFU of L. rhamnosus DM163. Fr

Sponsors

Apple Tree Medical Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals with at least one tooth in the Ramfjord teeth with a probing depth (PD) between 3 mm and 5 mm. Individuals with bleeding on probing (BOP) in 10% or more of the sites in the Ramfjord teeth. Individuals exhibiting symptoms of gingivitis or mild periodontitis. Individuals with 20 or more natural teeth (excluding roots, implants, and impacted teeth, but including crowned teeth).

Exclusion criteria

Exclusion criteria: Individuals with clinically significant cardiovascular, immune, infectious, or neoplastic diseases. Individuals with uncontrolled hypertension (=160/100 mmHg, measured after 10 minutes of rest). Individuals with uncontrolled diabetes (fasting blood glucose =180 mg/dL or those who have started new medication for diabetes within the last 3 months). Individuals with mental disorders such as schizophrenia, depression, drug addiction, or alcohol dependence. Individuals with a history of bleeding disorders or diseases, or those taking antiplatelet or anticoagulant medications for prevention. Individuals diagnosed with cancer within the past 5 years. Individuals who have taken medications that can affect periodontal status (e.g., phenytoin, CCBs, cyclosporine, coumadin, NSAIDs, aspirin) for more than 5 consecutive days within the past month. Individuals who have taken antibiotics or adjunctive treatments for periodontal disease within the past month. Pregnant women and women planning to become pregnant. Breastfeeding women. Women within 6 months postpartum. Heavy smokers (average of 25 or more cigarettes per day). Individuals who consume excessive alcohol (men: more than 4 drinks per day or 15 drinks per week; women: more than 3 drinks per day or 8 drinks per week; Ministry of Health and Welfare standards: 1 standard drink = 7 g alcohol = 50 mL soju = 200 mL beer). Individuals with allergies or adverse reactions to the test product. Individuals who have taken probiotics other than the test product from 1 month before the start of the study until the end of the study. Individuals who have participated in another clinical trial within the past month. Individuals deemed unsuitable for participation in the study by the researcher.

Design outcomes

Primary

MeasureTime frame
Probing depth and gingival index

Secondary

MeasureTime frame
Antiinflammatory, antibacteriual indicators and clinical parameters

Countries

Korea, Republic of

Contacts

Public ContactMU YEOL CHO

Apple Tree Medical Foundation

whanduf@appleden.com+82-70-4601-5479

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 27, 2026