Two-year clinical evaluation of a self-adhesive luting agent for ceramic inlays.
OBJECTIVE
The aim of this prospective randomized controlled clinical trial was to evaluate the 2-year clinical performance of a self-adhesive resin cement, RelyX Unicem (3M ESPE), used for cementation of ceramic inlays. In addition, the influence of selectively acid etching enamel prior to luting on marginal integrity, inlay integrity, tooth integrity, sensitivity, and complications of the restored teeth was assessed. The hypothesis tested was that there was no significant difference in these criteria between restorations with (Etch) or without prior enamel acid etching (Non-etch).


METHODS
Sixty-two IPS Empress 2 inlays/onlays were placed in 31 patients by two experienced clinicians. The restorations were luted with RelyX Unicem with (=experimental group; Etch) or without (=control group; Non-etch) prior enamel etching with phosphoric acid. At baseline, 6 months, 1 year and 2 years after placement, the restorations were assessed by two calibrated investigators using modified USPHS criteria.


RESULTS
The recall rate at 24 months was 96.6%. Two restorations were clinically unacceptable due to loss of retention, leading to a survival rate of 96.6% (Kaplan-Meier). No significant difference was noted between the experimental group and the control group regarding marginal integrity, inlay integrity, tooth integrity, complications and sensitivity (McNemar, p > 0.05). An obvious deterioration in marginal adaptation was observed after 24 months as only 21.7% (Etch = 23.4%; Non-etch = 20%) of the restorations exhibited an excellent marginal adaptation compared to 70.7% (Etch = 75%; Non-etch = 66.7%) at baseline. In 74.9% of the restorations, small, still clinically acceptable marginal deficiencies were observed (Etch = 76.6%; Non-etch = 73.2%).


CONCLUSIONS
The self-adhesive resin cement RelyX Unicem showed acceptable clinical behavior after two years of clinical service. Selective enamel etching prior to luting had no significant influence on marginal integrity, inlay integrity, tooth integrity, sensitivity or complications of the restored teeth after 24 months. Longer term evaluation is needed to confirm this finding.
Peumans
Marleen
M
Department of Conservative Dentistry, Oral Pathology and Maxillofacial Surgery, Catholic University of Leuven, Belgium. marleen.peumans@med.kuleuven.ac.be
De Munck
Jan
J
Van Landuyt
Kirsten
K
Poitevin
Andre
A
Lambrechts
Paul
P
Van Meerbeek
Bart
B
D000134:Acid Etching, Dental; D000293:Adolescent; D000328:Adult; D002484:Cementation; D018772:Dental Marginal Adaptation; D003776:Dental Porcelain; D003807:Dentin Sensitivity; D017220:Dentin-Bonding Agents; D005260:Female; D006801:Humans; D007284:Inlays; D053208:Kaplan-Meier Estimate; D018020:Lithium Compounds; D008297:Male; D008875:Middle Aged; D010756:Phosphoric Acids; D011446:Prospective Studies; D019279:Resin Cements; D018709:Statistics, Nonparametric; D055815:Young Adult
D017220:Dentin-Bonding Agents; C118557:Empress 2; D018020:Lithium Compounds; D010756:Phosphoric Acids; C483701:Rely X Unicem; D019279:Resin Cements; D003776:Dental Porcelain; C030242:phosphoric acid