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A multipractice clinical evaluation of an ORMOCER restorative--2-year results
Michael Rosin1, Christian Schwahn, Bernd Kordass
1Department of Restorative Dentistry, Periodontology and Pediatric Dentistry, University of Greifswald, Germany. rosin@uni-greifswald.de <rosin@uni-greifswald.de>
Objectives:
This ongoing prospective study evaluates the clinical performance of an ORMOCER restorative material (Definite; Degussa) in combination with a self-conditioning adhesive (Etch & Prime 3.0; Degussa).
Method And Materials:
Three hundred fifty-six restorations (48 Class I, 150 Class II, 63 Class III, 32 Class IV, and 63 Class V) in 117 patients (17 to 65 years) were placed by 5 operators at 5 centers. Fillings were placed with cotton roll isolation using clear matrix bands for Classes III and IV and metal matrix bands for Class II restorations. Follow-ups took place after 6, 12, and 24 months whereby modified Ryge criteria were recorded. With 33 randomly selected Class I and II restorations, measurements of occlusal wear (3-dimensional laser scanner) and marginal analyses (scanning electron microscope) were done using replicas.
Results:
At 24 months, 307 restorations were available for evaluation. The cumulative number of losses in the 5 cavity classes (I, II, III, IV, and V) and the percentages of scores for the clinical parameters in the 4 categories (Alfa, Beta, Charlie, and Delta) of the retained restorations were loss (1/ 6/ -/ 2/ 7), marginal integrity (93.1/ 6.9/-/-), marginal discoloration (73.5/ 25.5/ 1/ -), anatomic form (82.8/17.2/-/-), and fracture (93.1/ 6.9/-/ -). Marginal analysis showed 48.7% "continuous margin" initially and 13.2% at 24 months (difference statistically significant, a = 0.05). Occlusal wear at 24 months was 12.3 Microm for premolars and 21.4 Microm for molars.
Conclusions:
The overall clinical performance of the ORMOCER restorative over 24 months was acceptable with concerns related to marginal quality and to retention of Class V restorations.
