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

JRCT ID: jRCTs061230059

Registered date:13/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peri-implantitis Active
• Date of first enrollment: 10/10/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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 drainage period will be selected.)
Drug used in this study: Drug containing 2.5% Lactobacillus rhamnosus KO3

Outcome(s)

• Primary Outcome: Improvement rate to peri-implantitis Remission after 7 days of L8020 treatment in patients with peri-implantitis Active
• Secondary Outcome: Changes in the structure of the bacterial flora comprising the peri-implant sulcus

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yasuda Keisuke
• Source(s) of Monetary Support: JEX Co., Ltd.