Polymer-gel materials used as short-term denture soft linings are blended with plasticizers to lower the glass transition temperature (Tg). A lower Tg allows for greater polymer chain mobility, thus producing a more flexible material. The present work evaluated the loss of plasticizers due to leaching both in vivo and in vitro. Two commercial denture soft-lining materials (A and B) were tested. These were both poly(ethyl methacrylate) polymers, blended with alcohol and phthalate esters. A clinical study was conducted in which patients wore, sequentially, dentures bearing (on separate occasions) each of the two soft-polymer lining materials. The two materials A and B were randomly assigned for each of ten patients and were worn for 14 and 30 days, respectively. With one exception, patients wore dentures with both lining materials, for a total of 19 clinical evaluations. The plasticizer loss occurring during the clinical trial was determined by GC analysis from the initial and terminal day sampling of plasticizer content of the soft polymer-gel materials. The results of this analysis were compared with results obtained from an in vitro leachability study by use of sink conditions in water at 37 degrees C for the same two commercial soft polymers conducted over the same time periods of 14 and 30 days. The results indicated that a higher loss of plasticizer occurred in vivo, compared with the in vitro tests for 17 of the 19 clinical evaluations. The average plasticizer lost in vivo from material A at 14 days was 122 +/- 58 mg/g, and for material B at 30 days it was 33 +/- 27 mg/g.(ABSTRACT TRUNCATED AT 250 WORDS)
A number of studies have been made investigating the properties of dental prosthodontic soft polymer materials. In such materials, which are used as short-term denture soft liners, the polymer component is complexed with one or more plasticizers. This lowers the glass transition temperature, Tg, of the polymer by allowing greater chain mobility and produces a more flexible material. Little information is available relating to the polymer components of such soft-lining materials. The chemical composition and molecular-weight distribution of a polymer help to determine its ability to form a plasticized soft polymer-gel. In the present work, both pyrolysis depolymerization/gas chromatography (GC) and size exclusion chromatography (SEC) have been used to characterize 11 commercial polymer powders. By use of SEC and polymer standards having a narrow molecular-weight range, it has been possible for accurate molecular-weight distributions to be determined for all 11 powders. The peak molecular weights were found to be between 1.79 x 10(5) and 3.28 x 10(5). These values are above the molecular weight at which chain entanglement occurs. The polydispersity ratios (Mw/Mn) were between 2.09 and 4.48. Methacrylate polymers can be readily decomposed thermally to their constituent monomers, which, once recovered, can be analyzed by gas chromatography. The simple pyrolysis apparatus used in the present study was easily assembled and was capable of producing both qualitative and quantitative results. None of the commercial polymers analyzed gave methacrylate decomposition products with pendant chains greater than ethyl (-CH2-CH3). All of the commercial polymers successfully studied by the pyrolysis test method proved to be poly(ethyl [100-79%]/methyl [0-21%] methacrylate) polymers or co-polymers.
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