Tooth replacement
Conditions
Interventions
Group 1: test: Standard implant placement + Probiotic lozenges (BiGaiaTM Prodentis, Streulipharma, Switzerland), containing two Lactobacillus reuteri strains (ATCC PTA 5289 and DSM 17938), 2 times dai
Sponsors
Clinic of Conservative and Preventive Dentistry University of Zurich, Center of Dental Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be early wound healing, microbiological data, immunological data (IL-1ß, IL-6, IL-8, MMP-8), clinical measurements (PPD and BoP) and marginal bone remodelling analysed by comparison of x-rays. Early wound healing Early wound healing after 3 days (visit 4) and 2 weeks (visit 6) will be analyzed using the early wound healing score (EHS). Microbiological data The anticipated integration of the probiotic bacterial strains into the subgingival biofilm will be analyzed by Next Generation Sequence and fluorescent in situ hybridization in confocal laser scanning microscopy of L. reuteri in situ organization on healing abutments. Dysbiosis index will be done prior to ingestion of probiotics (visit 2) at a neighboring tooth, as a reference. Later dysbiosis index and Next Generation Sequence will be done after two weeks (visit 6), eight weeks (visit 7) and six months (visit 9). In situ analysis of L. reuteri will be performed on the healing abutments which are exchanged after eight weeks (visit 7). Immunological data Levels of IL-1ß, IL-6, IL-8 and MMP-8 in GCF samples will be assayed with gene expression analysis at the mRNA level by using real-time quantitative PCR (qPCR). GCF samples will be taken after two weeks (visit 6), eight weeks (visit 7) and six months (visit 9). Clinical measurements A clinical examination including Pocket Probing Depth (PPD) and Bleeding on Probing (BoP) at six sites with a calibrated PCP 12 periodontal probe (Hu-Friedy Mfg. Co., LLC., 60528 Frankfurt a. M., Germany) will be conducted by a single calibrated investigator (visit 8 and 9). Bone remodeling Marginal bone remodeling will be evaluated by comparing standardized periapical x-rays taken directly after implant placement (visit 3) to x-rays taken after six months (visit 9). | — |
Countries
Switzerland
Contacts
Public ContactTobias M. Janson
Clinic of Conservative and Preventive Dentistry University of Zurich, Center of Dental Medicine
Outcome results
None listed