Eight-year clinical evaluation of a 2-step self-etch adhesive with and without selective enamel etching. 2010

M Peumans, and J De Munck, and K L Van Landuyt, and A Poitevin, and P Lambrechts, and B Van Meerbeek
Leuven BIOMAT Research Cluster, Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillo-facial Surgery, Catholic University of Leuven, Kapucijnenvoer 7, B-3000 Leuven, Belgium. marleen.peumans@med.kuleuven.be

OBJECTIVE The objective of this randomized controlled clinical trial was to evaluate the 8-year clinical performance of a mild 2-step self-etch adhesive in non-carious Class-V lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins. METHODS A total of 100 non-carious Class-V lesions in 29 patients were restored with Clearfil AP-X (Kuraray). The composite restorations were bonded following two different approaches: (1) application of Clearfil SE (Kuraray) following a self-etch approach (control group; C-SE non-etch), (2) selective phosphoric acid-etching of the enamel cavity margins before application of Clearfil SE (experimental group; C-SE etch). The restorations were evaluated after 6 months, 1, 2, 3, 5 and 8 years of clinical service regarding their retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity. RESULTS The recall rate at 8 years was 76%. Only two restorations, one of the C-SE non-etch group and one of the C-SE etch group, were clinically unacceptable due to loss of retention leading to a retention rate and a clinical success rate of 97% in both groups. Aging of the restorations was characterized by an increase in the percentage of restorations with a small but clinically acceptable marginal defect (C-SE non-etch: 92%; C-SE etch: 84%) and/or a superficial marginal discoloration (C-SE non-etch: 44%; C-SE etch: 28%). At the enamel side, the presence of small marginal defects (C-SE non-etch: 86%; C-SE etch: 65%) and superficial marginal discoloration (C-SE non-etch: 11%; C-SE etch%) was more frequently noticed in the control group than in the experimental group. The difference, however, was only statistically significant for the presence of superficial marginal discoloration (McNemar, p=0.01). CONCLUSIONS After 8 years of clinical functioning, the clinical effectiveness of Clearfil SE remained excellent, with selective acid-etching of the enamel cavity margins only having some minor positive effect on marginal integrity and absence of marginal discoloration at enamel.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010756 Phosphoric Acids Inorganic derivatives of phosphoric acid (H3PO4). Note that organic derivatives of phosphoric acids are listed under ORGANOPHOSPHATES. Pyrophosphoric Acids,Acids, Phosphoric,Acids, Pyrophosphoric
D003188 Composite Resins Synthetic resins, containing an inert filler, that are widely used in dentistry. Composite Resin,Resin, Composite,Resins, Composite
D003743 Dental Enamel A hard thin translucent layer of calcified substance which envelops and protects the dentin of the crown of the tooth. It is the hardest substance in the body and is almost entirely composed of calcium salts. Under the microscope, it is composed of thin rods (enamel prisms) held together by cementing substance, and surrounded by an enamel sheath. (From Jablonski, Dictionary of Dentistry, 1992, p286) Enamel,Enamel Cuticle,Dental Enamels,Enamel, Dental,Enamels, Dental,Cuticle, Enamel,Cuticles, Enamel,Enamel Cuticles,Enamels
D003793 Dental Restoration, Permanent A restoration designed to remain in service for not less than 20 to 30 years, usually made of gold casting, cohesive gold, or amalgam. (Jablonski, Dictionary of Dentistry, 1992) Dental Fillings, Permanent,Dental Filling, Permanent,Dental Permanent Filling,Dental Permanent Fillings,Dental Restorations, Permanent,Filling, Dental Permanent,Filling, Permanent Dental,Fillings, Dental Permanent,Fillings, Permanent Dental,Permanent Dental Filling,Permanent Dental Fillings,Permanent Dental Restoration,Permanent Dental Restorations,Permanent Filling, Dental,Permanent Fillings, Dental,Restoration, Permanent Dental,Restorations, Permanent Dental
D003807 Dentin Sensitivity Pain associated with exposed DENTIN surfaces of the teeth. Dentin Hypersensitivity,Dentine Hypersensitivity,Dentine Sensitivity,Tooth Sensitivity,Dentin Hypersensitivities,Dentin Sensitivities,Dentine Hypersensitivities,Dentine Sensitivities,Hypersensitivities, Dentin,Hypersensitivities, Dentine,Hypersensitivity, Dentin,Hypersensitivity, Dentine,Sensitivities, Dentin,Sensitivities, Dentine,Sensitivities, Tooth,Sensitivity, Dentin,Sensitivity, Dentine,Sensitivity, Tooth,Tooth Sensitivities
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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