Objectives: Different composite materials for provisional crowns and fixed partial dentures (FPDs) were developed to improve mechanical properties and handling. Aim of the present clinical study was the assessment of the mechanical properties, selected periodontal parameter (GI, PI, BOP) and the handling of two composites [Protemp®3 Garant® (3M ESPE), Luxatemp® (DMG)] and one PMMA material (Dentalon® plus (Heraeus Kulzer)]. Methods: The temporary restorations were fabricated following a Clinical Investigation Plan. Stratified randomization (crowns/ FPDs) was used for material selection. For all patients the restoration located most posterior was included in the study. All restorations were made using impressions and fixed with Procem" under supervision of two dentists (E-MB, KU). The clinical examination at the first and second appointment after insertion were conducted by the clinical investigator or the dentist not involved in the manufacturing of the provisional restorations (blinded design). For the evaluation of the clinical performance an over-all parameter (Clinical Success Parameter, CSP) and a parameter assessing mechanical properties and patients' satisfaction (Clinical Success, CS) were calculated. The statistical analysis was performed using Fischer's exact test. Results: 121 patients were included in the study. 60 crowns, 35 FPDs and 26 splinted crowns were fabricated. The drop-out was 18 patients, 13 of them did not receive any provisional restoration. The median time under function was 16 days for Protemp®3 Garant®, 14 days for Dentalon® plus, and 13 days for Luxatemp®. CS was rated better for the Composites Protemp®3 and Luxatemp® compared to the PMMA-product Dentalon® plus. The median showed no alteration of the gingival health and no increased plaque adherence. Conclusion: The clinical reliability of the provisional restorations was high. No clinically relevant differences were found. This study was supported in part by the 3M ESPE AG, Seefeld, Germany. Ralph.Luthardt@mailbox.tu-dresden.de

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