Ontbrekende gebitselementen Missing teeth/ Diastema
Conditions
Interventions
In this study, one-piece zirconia implants are inserted in the jaw bone. This
is done with a widely used and well-documented implant type. Therefore, this is
not considered an experimental intervent
Sponsors
Academisch Centrum Tandheelkunde Amsterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: ·Male and female partially edentulous patients with missing anterior or premolar teeth in the maxilla or mandible. ·Patients requesting dental implants for the support of single crowns and/or short span 3 or 4 units fixed dental prostheis for the replacement of their missing teeth. ·Patients with stable general health (ASA1 & ASA2) ·Patients with adequate bone volume to accommodate implants with minimum length of 8mm and minimum diameter of 4.1mm (to allow ideal implant placement and avoid any implant preparation or grinding after implant insertion). ·Augmentation of surgical site, if needed should be performed pre-operatively before inclusion in the study
Exclusion criteria
Exclusion criteria: ·Patients under the age of 21 ·Patients with less than 4 intact remaining natural teeth (for superimposition of CBCT and Intra-oral scans) ·Any medical conditions contraindicating implant surgery ·Irradiated or bone-grafted jaws ·Use of intravenous bisphosphonates ·Heavy smoking (more than 10 cigarettes per day) ·Pregnant females at intake (because of exposure to CBCT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Does a digitally planned and fully-guided surgical protocol result in a more accurate placement of two-piece zirconia implants, and eliminate the need for any future preparation or grinding of the implant/abutment surface? Furthermore, the accuracy of the fully-guided (sleeved) vs. semi-guided (sleeveless) surgical protocol for the placement of two-piece zirconia implants will be assessed. This will be achieved via a form that registers any post-surgical adjustments, modifications, or preparations of the abutments and also by superimposing the planning intra-oral scan and CBCT files with post-surgical intraoral scans and digitally subtracting and comparing the proposed and the actual location of the implants. For the registration form, please see Appendix I. * For the digital subtraction, the outcome measures are: deviation at the implant apex (in mm), deviation at implant entry point (in mm) and angular deviation (in degree). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the degree of fit of the printed temporary restorations. This will be measured by superimposing the planning intra-oral scan and CBCT files with the actual intra-oral scans of the fitted restorations and digital subtraction of the fit of the temporary restorations. - Outcomes: mid-buccal of the cervical margin, mid-buccal of the mesial margin, mid-buccal of the distal margin. 2. Clinical evaluation of the fit of the final milled zirconia supra-structures. This is achieved by means of a questionnaire. The three possible outcomes are: perfect fit, acceptable fit, non-acceptable fit. Please see Appendix II. Digital subtraction of intra- oral scans will also be used for the evaluation of the fit as previously described for the temporary printed restoration. 3. Describe the survival rates and prosthodontic outcomes of zirconia implants, printed temporary restorations and the final milled monolithic Zirconia restorations at one- year follow-up period and annually thereafter for a 5-year period. 4. To evaluate the microbiological environment around two-piece zirconia implants using Next Generation Sequence technique. Please see Appendix III. | — |
Countries
Netherlands
Outcome results
None listed