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Inhibitory effect of local administration of Lactobacillus rhamnosus K03 (L8020) on peri-implantitis with suppuration

Inhibitory effect of local administration of Lactobacillus rhamnosus K03 (L8020) on peri-implantitis with suppuration

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061230059
Enrollment
10
Registered
2023-09-13
Start date
2023-10-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Peri-implantitis Active

Interventions

L8020 is administered topically in the peri-implant groove for peri-implantitis with drainage. (However, if there are multiple cases of peri-implantitis with suppuration, the implant with the longest

Sponsors

Yasuda Keisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Persons who are 18 years of age or older at the time consent is obtain 2. Those who can obtain written consent from the individual to participate in this study 3. Patients with implants that meet the diagnostic criteria for peri-implantitis for at least one year at the time of study entry. Peri-implantitis is defined as patients who meet the following diagnostic criteria i) Inflammation around the implant ii) Bone resorption around the implant 4. Patients with implants that have been known to drain for at least 3 months and have drained within 1 week prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients who have received a lactic acid bacteria preparation, bifidobacteria preparation, butyric acid bacteria preparation, or this drug as a prescription drug within 3 months prior to the start of administration of this drug. 2. Patients who have experienced serious adverse reactions to lactic acid bacteria, bifidobacteria, butyric acid bacteria, or this drug as ethical drugs in the past. 3. Patients who have received antimicrobial agents administered topically in the oral cavity or systemically by oral administration, etc. within 7 days. 4. Patients already using this drug.

Design outcomes

Primary

MeasureTime frame
Improvement rate to peri-implantitis Remission after 7 days of L8020 treatment in patients with peri-implantitis Active

Secondary

MeasureTime frame
Changes in the structure of the bacterial flora comprising the peri-implant sulcus

Contacts

Public ContactYuhei Hashimoto

Hiroshima University Hospital

hash588@hiroshima-u.ac.jp+81-822575677

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026