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: This is a monocentric, practice-based observational study in the dental practice Kluge (Jägerstraße 8 in 96247 Michelau, Germany) with one interventional study arm. With suitable patients (e.
On1- Abutments, surface XealTM) should be placed. Patients with switching or free-end gaps in the posterior maxilla or mandible will be included. Randomisation and blinding are not planned.
Sponsors
Zahnarztpraxis Kluge
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. as far as possible no remaining periodontal infection. - Good oral hygiene and compliance, i.e. full-mouth plaque score (FMPS) < 25% and full-mouth bleeding on probing score (FMBS) < 25%. - A 3D radiographic bone volume (possibly after augmentative procedures such as sinus lift) for placement of the intended implants must be available. - Patient and anatomical conditions must correspond to the instructions for use of the implants to be used (NobelParallelTM Conical Connection, surface TiUltraTM). - Edentulous areas must be suitable for the intended implant-supported restoration. - Sufficiently keratinised peri-implant mucosa. - Tooth extraction should generally be three months ago. - Existing opposing dentition - Patients must be willing to adhere to a prevention 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 antiresorptive drugs - Patients with known titanium allergy - Patients with CMD symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine peri-implant marginal bone level changes of functionally loaded implants at patient level after a study period of three years. | — |
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, 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 ContactJürgen Kluge
Zahnarztpraxis Kluge
Outcome results
None listed