Randomized clinical pilot study investigating the effect of Lactobacillus reuteri on subgingival biofilm formation on healing abutments and inflammatory status of surrounding peri-implant tissues

Phase 4

Recruiting

• Conditions: Tooth replacement

• Registration Number: DRKS00030602
• Lead Sponsor: Clinic of Conservative and Preventive Dentistry University of Zurich, Center of Dental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients requiring a single implant in the posterior area (premolars and molars, maxilla or mandible) with a single-tooth supported crown
• Patients 18 to 90 years of age
• no active periodontitis as determined by no PPD =6mm or no periodontitis, as determined by a PSI score of =2
• a full-mouth plaque score and full-mouth bleeding score <25% as recorded at 6 sites per tooth
• = 4 months post extraction
• Signed Informed Consent after being informed

Exclusion Criteria

• general medical condition, which represents a contraindication for implant treatment
• Systemic or local disease or condition that can compromise healing or osseointegration
• History of radiation in head-neck area
• current pregnancy (captured through inquiry)
• >10 Cigarettes daily
• Diabetes mellitus with an HbA1c > 7
• antibiotic therapy within the last = 4 weeks
• use of orally applied antibacterial products
• use of probiotic supplements
• use of anti-inflammatory drugs
• Use of drugs influencing bone metabolism
• marginal bone augmentation during implantation
• attached horizontal tissues =2mm after implantation
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early wound healing after 1 week (visit 5) will be analyzed as the primary outcome using the early wound healing score (EHS) by Marini et al. 2018.