K06.9
Conditions
Interventions
Group 1: Single-arm, practice based observational study of the behaviour of functionally loaded NobelParallel Conical Connection implants with the TiUltra surface in combination with multi-unit abutme
Sponsors
Zahnarztpraxis Drs. Thoneick
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Good general health (ASA = 2 [9]) a. Diabetes mellitus should be well controlled (HbA1c < 7). b. Smoking = 20 cigarettes / day c. No alcohol or drug abuse - No pathology of bone metabolism - Patients with periodontitis should have been successfully treated, i.e. as far as possible no remaining periodontal infection. - 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 radiographic bone volume (possibly after augmentative procedures such as sinus lift) for insertion of the intended implants must be available. - Patient and anatomical conditions must be in accordance with the instructions for use of the implants to be used (NobelParallelTM Conical Connection, TiUltraTM surface). - Edentulous areas must be suitable for the intended implant-supported restoration. - Sufficiently keratinised peri-implant mucosa. - Tooth extraction should generally be done three months before. - Existing opposing dentition - Patients must be willing to adhere to a preventive concept (supportive therapy, UT). This is a routine protocol. - Written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: - Minors - Pregnant and breastfeeding patients - Taking antiresorptives - Patients with known titanium allergy - Patients with CMD symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary project objective is to systematically record and evaluate the stability of the peri-implant bone level. The primary outcome variable is peri-implant marginal bone level changes of functionally loaded implants at patient level (?PMKPatient) after a study period of three years. Based on the data published so far, the project objective in particular, which is presumably related to the new TiUltraTM and XealTM surfaces (stability of the peri-implant bone level), is to be considered as exploratory (pilot study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary project objectives are the systematic recording and evaluation of the implant survival rate, biological complications (i.e. peri-implant mucositis, peri-implantitis), technical complications (i.e. implant fracture, abutment screw fracture, abutment screw loosening, prosthetic restoration fracture, prosthetic restoration loosening) and prosthetic restoration survival rate one, two and three years after prosthetic restoration. | — |
Countries
Germany
Contacts
Public ContactMaurice Thoneick
Zahnarztpraxis Drs. Thoneick
Outcome results
None listed