Ceramic Success Analysis Study of all-ceramic restorations

The study design

Welcome

Dear colleague, you are interested in the CERAMIC SUCCESS ANALYSIS (CSA). We, the ag keramik e.V., are very pleased about this. You are entering a new stage of your professional path as a dentist: you are taking part in the world's largest clinical study that reflects solely the treatment experience of practitioners. This is of great importance for all-ceramic systems, because only by taking note of successes and complications in practitioners' hands can all-ceramic systems be assessed over the long term, and can the systems be developed further on the basis of a broad body of data. In addition, this study already reflects the outstanding performance and treatment quality of the participating dentists. Furthermore, this study, of which you are now becoming part, creates evidence outside research and university that is already unparalleled. For you personally, however, the focus may be that CSA-online.net gives you a wider perspective on quality assurance in your practice. You will see under which conditions you achieve which results, and you can compare and interpret them with the results of your colleagues.

Here we briefly present the principles of this study.

1. Introduction

Dentists have been taking part in CSA for more than 10 years. The aim of this study is to observe all-ceramic restorations on single teeth over a long period. Inlays, onlays and single crowns in the posterior region are recorded, regardless of how they are made: directly chairside or indirectly in the laboratory. Besides various clinical conditions, the manufacturing method, the ceramic or framework ceramic used and, where applicable, the veneering ceramic are recorded. After the variables of the placement protocol have been entered, only the results of clinical check-ups are recorded in the period that follows.

The study entry is designed to spare you from entering redundant information as far as possible. In addition, there is context-related help and explanatory text throughout. In principle, data entry can be delegated to a trained member of staff. We also provide written guidance.

2. Study design

2.1 Number of cases

Each participant can initially take part with 50 cases (first cohort). Only one tooth per patient is recorded, i.e. the first tooth treated in a patient in the period that follows. After completing your first cohort, you can apply for a further cohort of 50 cases. This makes sense if, for example, you want to compare two different cementation protocols that you use in your practice, or if something essential in your treatment procedure has changed and you want to monitor this change over the long term as well.

2.2 Consecutive recording

The 50 cases must be recorded consecutively, i.e. if you start today, the next 50 all-ceramic single-tooth restorations must be included in the study protocol. Why? This study is designed as a scientific prospective study. You must therefore not leave out any case from the next 50 restorations, because otherwise you make a selection, intentionally or not, that distorts the validity of the later results for you and for the whole group.

2.3 Recording phase

First, your practice records 50 cases. Only one single-tooth restoration per patient can be recorded.

2.4 Check-up phase

After a restoration has been cemented, you carry out the dental check-ups as usual and document them in the re-examinations menu. This may extend over several years. The study includes check-ups as well as the occurrence of complications, such as a return visit because of pain on biting, gingivitis/periodontitis at the tooth, endodontic treatment, material complications such as chipping of ceramic, fracture of the marginal ridge or the like. Routine examinations should be documented at least once a year, but at intervals of at least 6 months. Ultimately, however, the timing of the documentation of check-ups, complications or failures reflects the clinical reality in your practice. You should not feel obliged to recall the study patients for check-ups more often!

3. Evaluations

The special feature of this software tool is the analysis of your data in comparison with the whole group, available at any time. For you this means immediate feedback on the success and on the clinical conditions under which you carry out your treatments. If you have questions about your evaluations, you can contact the scientific team of the ag keramik e.V. at wissenschaft@csa-online.net. By default you are offered 3 evaluations: A. The parameters of the placement protocol: you see a picture of your clinical procedure and of the conditions under which you provided your restorations, in comparison with the data of the whole group. As data from more than 5000 placement protocols are already available, you can quickly spot differences and interpret them in the context of your practice. B. The data of the re-examinations: first the frequencies of events and failures are shown in relation to the whole group, followed by a presentation that further differentiates the routine findings and events. C. A statement on the average survival of the restorations you have documented, in the form of a Kaplan-Meier survival probability chart. This chart is shown to you at the earliest one year after the first restoration has been entered, however.

4. Study conditions

The study meets all requirements of anonymity, both with regard to you as the practitioner and to your patients' data. All evaluations by the scientific team of the ag keramik e.V. and the evaluations on the website are carried out anonymously. If you wish, and note this separately, the scientific team will contact you if your observation data show strong deviations from the overall study data that make advice seem sensible from a clinical point of view. In addition, thanks to your ongoing access to your personal evaluations, you can of course contact the scientific team of the ag keramik to clarify your own questions about the evaluation.

5. Consent to the study

The study is carried out for purely scientific purposes. No commercial purposes are pursued, nor do you enter into any economic relationship with the ag keramik e.V. by joining the study. The data you provide are used anonymously and without commercial interests, and are made available to you for clinical re-evaluation. By consenting to the CERAMIC SUCCESS ANALYSIS study, you accept the conditions described here and in the terms of use.