Methods: 121 patients were included in the study. Different handling characteristics were examined during the manufacturing of the temporary restorations. Periodontal findings of every treated tooth and the adjacent teeth were collected and differences between pretreatment and post-treatment scores were analyzed. For the evaluation of the clinical performance an over-all parameter (Clinical Success Parameter, CSP) and a parameter assessing mechanical properties and patient's satisfaction (Clinical Success, CS) were developed. The clinical assessment was based on a system of modified CDA criteria. Two positive ratings (clinically good, clinically sufficient) and one negative rating (not acceptable) were created.
Results: Temporary restorations revealed a high level of clinical reliability. The median showed no alteration of the gingival health and no increased plaque adherence. CS was rated better for the Composites Protemp 3 and Luxatemp compared to the PMMA-product Dentalon plus. No differences were found concerning the over-all parameter CSP.
Conclusion: The surrogate parameter developed during the investigation seem to be adequate in order to evaluate clinical relevant differences between different groups.
The clinical trial was funded by 3M ESPE.