[Is it necessary to assess experimentally and clinically restorative materials already on the market?].
The precondition for introducing medical products, e.g. new filling materials, in the European Union is their safety, not their clinical reliability. The latter arises from longitudinal studies and is assessed on the basis of available standards or, if not existant, on formulated quality guidelines. In the case of the specific products Ariston Liner and Ariston pHc (Vivadent, Schaan, FL), designed as an amalgam substitute, the material combination did not correspond to the Swiss standard 2 of restorative dentistry. Although after a short-term application testing on caries free premolars the pulp and dentin were free from inflammation and bacteria, the material combination clinically failed within the 18 months control period with a cumulative failure rate of 16.1% due to marginal caries. After six months of function the subjectively assessed sensitivity tended to increase. Gap formations and porous zones were detected in the composite-tooth-interface in vitro as well as in vivo. Neither the lining, designed to ensure the passage of cations and anions out of the filling material, nor the concept of an adequate caries protective effect proved successful. Marginal caries and hypersensitivity of teeth were the main reasons for the replacement of this amalgam substitute. The specific material combination was withdrawn from the market. As long as laboratory methods cannot substitute clinical evaluations, the introduction of new materials or systems into the market should be supported by short-term clinical studies and the further quality assessment should result from intermediate to long-term longitudinal studies. In this respect guidelines are valuable, such as the Swiss guidelines concerning materials as amalgam substitute.
Merte
Ilka
I
Poliklinik für Konservierende Zahnheilkunde und Parodontologie, ZZMK, Universität Leipzig.
Schneider
Hartmut
H
Merte
Knut
K
D000180:Acrylic Resins / Q000009:adverse effects; D003188:Composite Resins / Q000009:adverse effects / Q000592:standards*; D003731:Dental Caries / Q000209:etiology; D003763:Dental Leakage / Q000209:etiology; D019232:Dental Restoration Failure; D003793:Dental Restoration, Permanent / Q000009:adverse effects / Q000592:standards*; D003807:Dentin Sensitivity / Q000209:etiology; D005062:European Union; D006801:Humans; D008689:Methacrylates / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013557:Switzerland; D014082:Tooth Fractures / Q000209:etiology
D000180:Acrylic Resins; C409382:Ariston pHc; D003188:Composite Resins; D008689:Methacrylates; C454691:ariston liner