K08
Conditions
Interventions
Group 1: 40 patients in whom the replacement of one or more missing tooth/teeth (interdental gap or free-end situation) in the posterior region in the upper or lower jaw by an implant-prosthetic resto
Sponsors
Zentrum für Zahnmedizin Prof. Dr. Schnutenhaus MVZ GmbH
Oral Reconstruction Foundation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Interdental gaps in the maxillary and/or mandibular posterior region - Free-end situations in the maxillary and/or mandibular posterior region o The extraction was at least 3 months ago. Only early implantations (3 - 6 months post extraction) and late implantations (> 6 months post extraction) are performed. - A contralateral natural tooth must be present as a reference tooth, as well as antagonistic dentition. - The patient has good oral hygiene and compliance. - A pre-implant hygiene phase must have been completed. - The patient's declaration of consent is available.
Exclusion criteria
Exclusion criteria: - Persons under 18 or persons lacking legal capacity - Untreated acute periodontitis with pocket depths > 4 mm. - Heavy smokers (more than 10 cigarettes per day) - Taking bisphosphonates - Pregnant women - Alcohol or drug addicts - Patients with an infectious disease such as hepatitis, HIV or AIDS - Patients with severe diabetes mellitus. - Immediate implantations - Primarily recognizable need for augmentation - Width of the gap in the mesio-distal direction for single-tooth gaps > 6.8 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant loss in an observation period of 5 years after insertion differentiated according to the two forms of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Biological and technical complications of the implant-crown complex - Clinical parameters: Probing Depth (PD), Ginigival Index (GI), Plaque Index (PI), Bleeding on Probing (BOP), stability of the implant (PerioTest) and bone resorption (standardized radiographs). Collection of clinical data: Baseline, 6, 12, 24, 36, 48, 60 months Radiological data collection: baseline, 12, 36, 60 months - Technical complications: Chipping, screw loosening or screw fractures. Recording: when the complication occurs - Aesthetic outcome (Pink Aesthetic Score according to Fürhauser et al. 2005) Data collection: Baseline, 12,36,60 months - Patient satisfaction (PROMs) Collection of data: Baseline, 12, 36, 60 months - Cost-effectiveness of the procedures. This aspect of the study uses the data from the randomized clinical trial to perform a cost-benefit analysis in the test and control group with the described procedure (piggy-back). Cost-effectiveness is compared with patient satisfaction on the basis of documented treatment costs (dental and technical services and material costs). Ongoing data collection | — |
Countries
Germany, Switzerland
Contacts
Public ContactSigmar Schnutenhaus
Zentrum, für Zahnmedizin Prof. Dr. Schnutenhaus MVZ GmbH
Outcome results
None listed