Inhibitory effect of local administration of Lactobacillus rhamnosus K03 (L8020) on peri-implantitis with suppuratio
- Conditions
- Peri-implantitis ActiveD057873
- Registration Number
- JPRN-jRCTs061230059
- Lead Sponsor
- Yasuda Keisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement rate to peri-implantitis Remission after 7 days of L8020 treatment in patients with peri-implantitis Active
- Secondary Outcome Measures
Name Time Method Changes in the structure of the bacterial flora comprising the peri-implant sulcus