RESUMEN
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.
Asunto(s)
Cerámica/química , Materiales Dentales/química , Retención de Prótesis Dentales/estadística & datos numéricos , Fracaso de la Restauración Dental , Alisadura de la Restauración Dental/estadística & datos numéricos , Silanos/química , Adolescente , Adulto , Anciano , Adaptación Marginal Dental , Humanos , Rayos Láser , Persona de Mediana Edad , Cerámicas Modificadas Orgánicamente , Estudios Prospectivos , Estadísticas no ParamétricasRESUMEN
The purpose of this ongoing prospective long-term study was to evaluate the clinical performance of Ormocer restorative material in combination with a self-conditioning adhesive. Five operators at five clinics placed 356 restorations (48 class I, 150 class II, 63 class III, 32 class IV, and 63 class V) in 117 patients aged 17 to 65 years. All fillings were placed with cotton roll isolation and clear matrix bands for class III and IV restorations, and metal matrix bands and an incremental placement technique were used for class II restorations. In follow-up examinations after 6 and 12 months, modified Ryge criteria were recorded on all restorations. With 33 randomly selected class I and II restorations, measurements of occlusal wear (via 3D laser scanner) and qualitative and quantitative marginal analysis (via scanning electron microscope) were performed using a replica technique. After placing the fillings, patients reported postoperative hypersensitivity corresponding to B scores in 19 cases and to C scores in four cases. At 12-month recall, 328 restorations were available for evaluation. Losses in the five cavity classes (I, II, III, IV, V) numbered 0, 2, 0, 1, and 6, respectively. The percentages of retained restorations for clinical parameters in four categories (Alpha, Beta, Charlie, Delta) were: 94.7, 5, 0.3, and 0 (marginal integrity), 81.2, 18.8, 0, and 0 (marginal discoloration), 75.2, 24.8, 0, and 0 (anatomic form), and 95, 4.7, 0.3, and 0 (fracture), respectively. Marginal analysis showed 48.7% "continuous margin" initially and 17.7% at 12 months (difference statistically significant, P=0.05). The occlusal wear at 12 months was 10.0 microm (SD 11.6) for premolars and 22.0 microm (SD 24.1) for molars. Over the 12-month observation period, the Ormocer restorative was clinically effective in combination with a self-conditioning adhesive, and concern persists related to the marginal quality and retention of class V restorations.