Z96.5
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 will be placed on
Sponsors
Z-MVZ Zahnärzte am Exe GmbH
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) a. Diabetes mellitus should be well controlled (HbA1c < 7) 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 planned implant-supported restoration. - Sufficiently keratinised peri-implant mucosa. - Tooth removal should generally have taken place 12-16 weeks previously (i.e. early implant placement type III). - 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 aim is marginal peri-implant bone level change. Point in time Patient treatment Before enrolment in the clinical trial - Pre-selection of patients - 3D X-ray images - Patient information - Written declaration of consent to participate - Clinical examination - Treatment planning - implant planning - Supportive therapy UT (if necessary) Inclusion in the observational study - Implantation - Digital X-ray - Transgingival healing Generally twice a year UT. + usually 6 weeks - Start of the prosthetic restoration in a digital workflow - Implant loss (early loss) + 1-2 week - Insertion of the prosthetic restoration - Digital X-ray image (RöBL) + 2 weeks - Checking the static and dynamic occlusion - Recording (photo) of the static (blue occlusion paper) and dynamic dynamic (red occlusion paper) occlusion + 3 months after insertion of the prosthetic restoration Clinical examination (implants only) - Implant loss (late loss) - Biological complications - Technical complications - Loss of the prosthetic restoration + 1, 2, 3 years after insertion of the prosthetic restoration Clinical examination (teeth and implants) - Implant loss (later loss) - Biological complications - Technical complications - Loss of the prosthetic restoration - Digital X-ray (X-ray years) The minimum total study duration for the individual patient is therefore approx. 3 years and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are 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 ContactAmien Andabili
Z-MVZ Zahnärzte am Exe GmbH
Outcome results
None listed