Dental implantology within the scope of routine dental treatment and thus also within the scope of the intended purpose of a Class IIb medical device (MP) with CE marking in a dental practice.
Conditions
Interventions
Group 1: In suitable patients (e.g: willingness to participate in the observational study over a period of three years), implant-supported single crowns with screw-retained abutments should be placed
Sponsors
Zahnzentrum Porta
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Mentally healthy adults, i.e. patients capable of giving consent - Good general health (ASA = 2 [16]) a. Diabetes mellitus should be well controlled (HbA1c < 7 [17]) b. Smoking = 20 cigarettes / day c. No alcohol or drug abuse - No pathology of the bone metabolism - Patients with periodontitis should be successfully treated, i.e. no remaining periodontal infection as far as possible - Good oral hygiene and compliance, i.e. plaque level (full-mouth plaque score, FMPS) < 25% and bleeding level after probing (full-mouth bleeding on probing score, FMBS) < 25% - A 3D radiological bone volume (possibly after augmentative procedures such as sinus lift) must be available for insertion of the planned implants. - Patient and anatomical conditions must correspond to the instructions for use of the implants to be used (Straumann® BLX implants with the SLActive® surface). - Edentulous posterior areas must be suitable for the intended implant-supported restoration. - Sufficiently keratinised peri-implant mucosa. - Tooth removal should generally have taken place 4-8 weeks ago (i.e. early implant placement type II). - Existing opposing dentition - Patients must be prepared to adhere to a prevention concept (supportive therapy, UT). This is a routine protocol. - Written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: - Minors - Pregnant and breastfeeding patients - Taking antiresorptives - Patients with a known titanium allergy - Patients with CMD symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to systematically record and evaluate the stability of the peri-implant bone level one, two and three years after prosthetic restoration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are the systematic recording and evaluation of the implant survival rate, implant survival rate, biological complications (i.e. peri-implant mucositis, peri-implantitis), technical complications (i.e. implant fracture, abutment screw fracture, abutment screw loosening, fracture of the prosthetic restoration, loosening of the prosthetic restoration) and survival rate of the prosthetic restoration one, two and three years after prosthetic restoration. | — |
Countries
Germany
Contacts
Public ContactBjörn Kranz
Zahnzentrum Porta
Outcome results
None listed