Evaluation of resin composite materials. Part II: in vivo investigations.
OBJECTIVE
To clinically evaluate two different resin-based composites (Solitaire I and Ariston pHc) in order to determine the minimum clinical evaluation time needed to detect critical signs of failure.


METHODS
In a controlled prospective clinical study, 99 cavities (30 Class I, 69 Class II) in 31 patients were restored (50 Ariston pHc without enamel etching and rubber dam, 49 Solitaire I restorations with total etching and rubber dam) and clinically investigated at baseline, after 6, 12, and 24 months.


RESULTS
After 2 years of clinical service, 49 restorations (Ariston pHc: n = 38, Solitaire: n = 11) had to be replaced. The majority of failures occurred after more than 1.5 years. The reasons for replacement were differently distributed in both groups (Ariston pHc: 28 tooth fractures, 3 gap formations, 5 hypersensitivities, 1 bulk fracture, 1 marginal fracture. Solitaire: 5 gap formations, 1 hypersensitivity, 3 bulk fractures, 1 wear of the restorative material, 1 void in the restoration). Forty-four restorations were still in function after 2 years (overall failure rate after 2 years: 14%; Ariston pHc: 17%; Solitaire: 7%; survival analysis algorithm according to Kaplan/Meier). Comparing the materials, no statistical differences were evident except for the criteria "integrity tooth" (= tooth fracture or cracks) and "hypersensitivity" (from the 12-month recall; Mann-Whitney U-test; P< 0.05). In both cases of significant difference, Ariston pHc exhibited inferior results. After 2 years, only three teeth restored with Ariston pHc did not show considerably cracked enamel. The additional marginal analysis showed statistically significant differences for both materials regarding the criteria "perfect margin" (decrease), "gap formation" (increase), and "negative step formation" (increase; P< 0.05; Friedman 2-way ANOVA) between the four recalls. Therefore, a 2-year in vivo evaluation should be recommended prior to marketing a dental restorative material.
Krämer
Norbert
N
Department of Operative Dentistry and Periodontology, University of Erlangen-Nuremberg, Glueckstrasse 11, D-91054 Erlangen, Germany. kraemer@dent.uni-erlangen.de
García-Godoy
Franklin
F
Frankenberger
Roland
R
D000134:Acid Etching, Dental; D000180:Acrylic Resins / Q000737:chemistry; D000328:Adult; D003188:Composite Resins / Q000737:chemistry*; D003737:Dental Cavity Preparation / Q000145:classification; D018772:Dental Marginal Adaptation; D019232:Dental Restoration Failure; D019554:Dental Restoration Wear; D003793:Dental Restoration, Permanent; D003807:Dentin Sensitivity / Q000209:etiology; D017220:Dentin-Bonding Agents / Q000737:chemistry; D004852:Epoxy Compounds / Q000737:chemistry; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008422:Materials Testing; D008689:Methacrylates / Q000737:chemistry; D008875:Middle Aged; D011446:Prospective Studies; D013499:Surface Properties; D014082:Tooth Fractures / Q000209:etiology
D000180:Acrylic Resins; C409382:Ariston pHc; D003188:Composite Resins; D017220:Dentin-Bonding Agents; D004852:Epoxy Compounds; D008689:Methacrylates; C407604:Solid Bond; C113049:Solitaire composite resin; C454691:ariston liner