Thank you for your interest in the CERAMIC SUCCESS ANALYSIS (CSA). We, the Society for Dental Ceramics, are very pleased to welcome you to a new phase in your professional life as a dentist: you are about to participate in the largest clinical study in the world which solely reflects the treatment experience of practitioners. In terms of all-ceramic systems, this is of great importance, because only by paying attention to success and complications from the practitioner’s point of view is a long-term assessment of the all-ceramic systems possible, and only then can the systems be further developed and improved based on a broad data set. Even now, this study can already document the outstanding performance and treatment quality of the participating dentists. Moreover, through this study – of which you are now a part – an evidence base is being created outside the realm of research and university, an unparalleled development. But the central point for you personally is that CSA-online.net gives you a broader view of the quality assurance in your office. You’ll discover under what conditions you reach which results, and you’ll be able to compare and interpret this against the results of your colleagues.
In the following, we will briefly acquaint you with the principles of this study.
For over 10 years now, dentists have been participating in the CSA. The aim of the study is to observe all-ceramic single-tooth restorations over the long term. Inlays, onlays and single crowns are included, regardless of whether they were fabricated directly or indirectly in the dental laboratory. Besides various clinical conditions, the manufacturing process and the ceramic or framework ceramic (and, if applicable, veneering ceramic) used are recorded. After entering the variables of the insertion examination, only the results of clinical follow-ups are subsequently documented.
The documentation of the study is set up so that you are largely relieved of entering redundant information. In addition, there are help and explanation texts for each context. Data entry can also be delegated to an appropriately instructed co-worker. In addition, we will supply you with written support.
2. Study design
2.1 Number of cases
Every participant can initially take part with 50 cases (first cohort). Only one tooth per patient is documented, i.e., in each case, the first tooth treated in a patient in the subsequent time period. After completing your first cohort, you can apply for another cohort of 50 cases. This makes sense if, for instance, you want to compare two different luting protocols that you use in your office, or if substantive changes have been made in the work/treatment flow, and you wish to monitor this in the long term as well.
2.2 Consecutive documentation
The 50 cases must be consecutively documented, that is, if you begin today, you must include the next 50 all-ceramic single-tooth restorations in the study protocol. Why? This study is designed as a scientific, prospective study. For that reason, you may not omit any of the next 50 restorations, because otherwise you would intentionally or unintentionally be making a selection, which would damage the validity of later results – for you and for the entire group.
2.3 Documentation phase
First, your practice will document 50 cases. Only one single-tooth restoration per patient can be documented.
2.4 Control phase
After luting a restoration, perform the follow-up examinations as you always have, and document these in the menu “Follow-up Examinations”. This may continue for several years. Not only follow-up examinations are entered into the study, but also complications, such as new appointments due to bite-down complaints, occurrence of gingivitis/periodontitis on the tooth, endodontic procedures, material complications such as chipping of the ceramic, marginal fracture, etc. Normal examinations should be documented at least once a year, but no more than at 6-month intervals. After all, the timepoint of the documentation of controls, complications, or failures reflects the clinical reality in your practice. You should not feel obliged to recall the patients enrolled in the study more often than you otherwise would!
The special feature of the present software tool is that you can analyze your data compared to the total group at any time. For you, this means immediate feedback on the success and clinical conditions under which you perform your treatments. If you have questions about the results of your evaluation, you can contact the scientific team of the Society of Dental Ceramics (SDC) under email@example.com. You will be offered 3 standard evaluations: A. The parameters of the insertion examination: You will see a representation of your clinical process and the conditions under which you performed your restorations compared to data from the whole group. Because data from over 5000 insertion examinations are already available, you can quickly see the differences and interpret them in the context of your practice. B. The data from the follow-up studies: first, the frequencies of events and failures compared to the entire group are shown, followed by a diagram which further differentiates the routine findings and the events. C. A statement on the average survival rate of the restorations you documented, in the form of a Kaplan-Meier survival probability curve. However, this graph will be shown to you at the earliest one year after entering the first restoration.
4. Study conditions
The study meets all requirements for ensuring your anonymity as an operator, as well as for the anonymity of patient data. All evaluations by the scientific team of the Society for Dental Ceramics and the analyses on Internet websites are conducted anonymously. If you wish and separately indicate such, you will be contacted by the scientific team if your data show pronounced deviations from those of the study as a whole and a consultation would make sense from a clinical point of view. In addition, you may of course contact the scientific team of the SDC to discuss any questions you may have about your evaluation.
5. Participation agreement
The study is being conducted for purely scientific purposes. No commercial ends are being pursued, nor does your joining the study entail entering into a commercial relationship with the SDC. The data you make available will be strictly anonymously analyzed without commercial interests, and will be returned to you for clinical re-evaluation. With your agreement to participate in the study CERAMIC SUCCESS ANALYSIS, you declare your acceptance of the conditions described here and in the conditions for use.