Clinical Evaluations
Filtek Supreme Ultra Universal Restorative (6 yr)
Description
FiltekTM Supreme Ultra Universal Restorative is a composite indicated for anterior and posterior restorations. The composite is filled 63% by volume with a combination of 4-20 nm particles and loosely-bound clusters of these particles, 0.6-10 micron in size. The composite is radiopaque. Cure times, using a high intensity LED curing light, are 10 seconds for the body, enamel and translucent shades and 20 seconds for the dentin shades. Filtek Supreme Ultra Universal Restorative is available in 4 g syringes and 0.2 g single-dose capsules.
Clinical Evaluation Protocol
598 restorations were placed over a 6-year period. Restorations were evaluated for esthetics, resistance to fracture/chipping, resistance to marginal discoloration, and wear resistance on a 1-5 rating scale: 1=poor, 2=fair, 3=good, 5= excellent. Th e distribution of restorations is shown in Figure 1. The years in service of restorations is shown in Figure 2.
Clinical Observations
Esthetics
Filtek Supreme Ultra Universal Restorative shades blended extremely well with the surrounding tooth structure. The availability of numerous shades helped in achieving superior esthetics in the vast majority of recalled restorations. Eighty-nine percent of the restorations received a 5 or excellent rating, 9% a 4 or very good rating and 2% received a 3 or good rating (Figure 3). None of the restorations were replaced due to lack of esthetics. Often the recalled restorations exhibited a very smooth and shiny surface texture with margins that were difficult to discern from tooth structure.
Resistance to Fracture/Chipping
Ninety-five percent of the recalled restorations exhibited no chipping or fracture (Figure 3). Of the fifteen restorations (5%) that chipped or fractured only 5 (1.3%) required replacement; the rest were smoothed, re-contoured or repaired with flowable composite.
Resistance to Marginal Discoloration
Ninety-one percent of restorations had no visible staining at the margins and received a rating of 5 (Figure 3). Eight percent had minimal staining at the margins not requiring replacement with a rating of 3 or 4. Only 1% of the restorations needed to be replaced due to marginal discoloration, probably as a result of the bonding agent. The bonding agents used were: 5th-, 6th- and 7th-generation bonding agents.
Wear Resistance
Ninety-seven percent of the recalled restorations exhibited no wear while 2% exhibited minimal to moderate wear with a rating of 4 or 3 (Figure 3). Only 1% of the restorations required replacement due to excessive wear. These restorations had wear at the incisal edges of upper or lower anterior teeth as result of bruxism.
Discussion
Among the 302 recalled restorations, there were 24 restorations (8%) replaced as a result of recurrent decay. Another 1% were repaired due to open contacts or after root canal treatment or fracture of the tooth. These failures were not attributed to the composite.
Summary
Overall Filtek Supreme Ultra Universal Restorative performed exceptionally well in the categories of esthetics, resistance to fracture/chipping, resistance to marginal discoloration, and wear resistance. Two other areas of interest that THE DENTAL ADVISOR tracked were the number of restorations replaced and those that debonded. Thirteen restorations debonded, 10 were facial and 3 were incisal. This is often due to the bonding agent and technique. Forty-three restorations (14%) were replaced. The most common reason for replacement was decay (8%), fracture/chipping (3%), marginal discoloration (2%) and wear (1%). Another 1% were repaired due to open contacts or after root canal treatment or fracture of the tooth. These were not material related. FiltekTM Supreme Ultra Universal Restorative received a clinical performance rating of 98% at six years.