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946  dental materials 3 3 ( 2 0 1 7 ) 944–953



 Table 1 – Distribution and size of the experimental restorations.
 Surfaces  Maxilla  Mandibula  Total
 Premolars  Molars  Premolars  Molars
        Table 2 – Resin composites and adhesive system used.
 2 surfaces  20  32  15  22  89  Material  Composition      Type              Application steps       Manufacturer
 3 surfaces  3  7  5  11  26  cfm  cmf etch: buffered phosphoric  3-step etch-and-rinse light  • Etch for 15 s enamel and  Saremco AG, Rebstein,
 >3 surfaces  2  12  1  9  24  acid (pH = 1.5)       curing adhesive system  dentin              Switzerland
 Total  25  51  21  42  139    cmf primer: metacrylated                    • Rinse for maximally 10 s
                               phosphoric salt, alcohol,                   • Air dried carefully for ca 5 s.
                               aceton, CQ, co-initiator                    • The cmf primer was applied
 of the study, which was approved by the ethics committee of  the evaluated RC restorations belonged to nor of the earlier  cmf bonding: hydrophilic  using a rubbing motion for
 the University of Umeå (Dnr 07-152M).  recall evaluation scores. Cohen-kappa values performed dur-  ethoxylated Bis-GMA, silanized  30 s, followed by a careful 5 s
                               barium glass, CQ, co-initiator.              air blowing to remove
 Reasons for placement of the resin composite restorations  ing the follow up were >86%. Bite-wing radiographs were taken  solvent. Light cure 20 s
 were carious lesions, fracture of old fillings or replacements  at the yearly recalls. The participants were asked at their  • The cmf bonding was  dental
                                                                            applied using a rubbing
 due to esthetic or other reasons. No Class I cavities were  next visit and at all recalls if they had experienced symp-
                                                                            motion for 20 s
 HEMA-free resin composite system   TEGDMA/HEMA-free low shrinkage   were performed under local   • Light cure for 20 s
 included because of the relative good durability of these
 toms in the region of the experimental teeth The caries risk
 was developed with low volumetric   resin composite (els;Saremco AG,   anesthesia if necessary. Sixty-seven   AdheSE One F  Bis-acrylamide derivative,  single-step self-etching,  • Dry surface  Vivadent Ivoclar, Schaan,  materials
 of each participant and their parafunctional habits activity at
 restorations. Operative procedures were performed under
 shrinkage and low contraction   Rebstein, Switzerland), and bonded   patients, 33 female and 34 male, with   bis-methacrylamide  light-cured, nano-filled, with  • An adequate amount of  Liechtenstein
 local anesthesia if necessary. Sixty-seven patients, 33 female
 baseline and during the follow ups was estimated by treating
 stress  . In its 3-step etch-and-  either with the TEGDMA/HEMA-  a mean age of 53 years (range 29–82)   dihydrogenphosphate, amino  fluoride release in a pen  AdheSE One F was directly  3 3
 40
 clinician by means of clinical and socio-demographic informa-
 and 34 male, with a mean age of 53 years (range 29–82) par-
                                                     delivery system
                                                                            applied to the cavity with the
                               acid acrylamide, hydroxyalkyl
 rinse adhesive, smaller hydrophilic   free 3-step etch-and-rinse adhesive   participated in the study. One hundred   methacrylamide 20–40%, water  VivaPen.
 ticipated in the study. One hundred and thirthy-nine Class II
 tion routinely available at the annual clinical examinations,
 monomers were omitted resulting in   of the system (cmf, Saremco) or a   and thirty-nine Class II restorations   alcohol solvent 20–30%,  • The adhesive was brushed  ( 2 0 1 7 )
 restorations were placed in 46 premolars and 93 molars by
 e.g. incipient caries lesions, former caries history, frequency,
                                                                            into the entire surface for
                               stabilizers, initiators. highly
 amore hydrophobic resin layer, which   single-step HEMA-free self-etching   were placed in 46 premolars and 93   dispersed silicon dioxide, pH  30 s.
 dietary habits, oral hygiene, medications, salivary properties
 one experienced operator (JvD) (Table 1). All, except 5 patients,
 is less prone to water absorption   adhesive in a pen delivery system   molars by one experienced operator   1.4  • Air blow for more than 5 s  944–953
 received at random two restorations with the two restorative
 and symptoms related to bruxing activity [45,46]. All patients
                                                                            until a glossy, immobile
                               fillers <5%, potassium fluoride
 and hydrolytic degeneration  41,42 . The   (AdheSE One F, VivadentIvoclar,   (JvD) (Table 1). All, except 5 patients,   liquid film appeared.
 techniques. The 5 participants received also one more Class II
 were informed about the follow up evaluations according
 HEMA substitution for Bis EMA, which  teeth were in occlusion.  to the rules at  received at random two restorations   • Light-cure for 10 s.
 restoration with the cmf adhesive. All
 Schaan, Liechtenstein; ASE). The els  the PDHS clinic at the Dental School Umeå.
 represents high molecular weight   resin composite does not contain  treatment was given to the patients in confor-  els (extra low shrinkage)  Bis-GMA, Bis-EMA, IBMA,  low shrinkage resin composite  Applied in 2–3 mm layers,  Saremco, Switzerland
 with the two restorative techniques.
 Concomitant
 The majority of cavities had dentin bordered proximal cervical
 may result in reduced toxicity. Clinical   comonomers of low molecular weights clinical routines at the clinic. Patients were  catalysts, inhibitors, pigment  volume shrinkage 2.3%,  oblique when possible.
 The 5 participants received also one
 margins.
 mity with normal
 more Class II restoration with the cmf
 effectiveness of the resin composite   and showed the lowest contraction  contact the clinic immediately if any discomfort  filler: Ba glass, Ba-Al-B-Si glass,  shrinkage stress after 30 min:  Light cured 20–40 s per layer
 instructed to
                                                     2.6 MPa
                               silanized, ø 0,7  m, max.
 system in Class V non carious cervical   stress of marketed resin composites   adhesive. All teeth were in occlusion.  2,6  m, 74 wt%, 50 vol.%.
 occur.
 Clinical procedure
 2.2.
 lesions was reported recentlyin a   40,41 . During 2009, adult patients   The majority of cavities had dentin   Abbreviations: HEMA 2-hydroxyethyl-methacrylate, 4-MET 4-methacryloxyethyl trimetellitic acid, IBMA, isobornylmethacrylate, PENTA Phosphoric acid modified acrylate resin, TCB resin carboxylic
        acid modified dimethacrylate, TEGDMA triethyleneglycol dimethacrylate, Bis GMA bisphenol A-glycidyl methacrylate, Bis EMA Bisphenol A ethoxylate dimethacrylate, UDMA urethane dimethacrylate;
 5-year follow up  , but no clinical   attending the Public Dental Health   bordered proximal cervical margins.  CQ camphoroquinon.
 43 of the old restorations and/or caries excavation
 After removal
 Statistical analysis
 2.4.
 according to the principles of adhesive dentistry, the opera-
 study reported the durability in Class   Service clinic at the Dental School   CLINICAL PROCEDURE
 tive field was carefully isolated with cotton rolls and suction
 II restorations.The aim of the present   Umeå, who at the yearly examination   After removal of the old restorations
 The characteristics of the restorations are described by
 device. No bevel was placed. For all cavities a thin metallic
 randomized controlled prospective   did need two Class II restorations  statistics using cumulative relative frequency  7,Vivadent; Demetron light meter, Kerr,   restorations belonged to nor of the   to the rules at the PDHS clinic at the
 and/or caries excavation according
 descriptive
 matrix was used and carefully wedging was performed with
 to the principles of adhesive dentistry,
 study was to investigate the clinical   were asked to participate in a clinical  the scores. The experimental and control  Orange, CA, USA). The low shrinkage   earlier recall evaluation scores. Cohen-  Dental School Umeå. Concomitant   947
 distributions of
 longevity of Class II restorations   follow up. No patients were excluded   the operative field was carefully  with  resin composite (els, Saremco) was   kappa values performed dur-ing the   treatment was given to the patients in
 restorative techniques were compared intra-individually
 wooden wedges (Kerr/Hawe Neos, Switzerland). No Ca(OH) 2
 base or other base material was used. The cavities in each
 performed with the TEGDMA/HEMA-  because of caries risk, bruxing habits   isolated with cotton rolls and suction   applied in all cavities in layers of   follow up were >86%. Bite-wing   conformity with normal clinical routines
 the non parametric Friedman two-way analysis of variance
 individual pair were randomly distributed to the two test
 test [47]
 free resin composite system. The   or not acceptable oral hygiene.   device. No bevel was placed. For all   maximally 2–3 mm with if possible,   radiographs were takenat the yearly   at the clinic. Patients wereinstructed
 adhesives, before the operative procedure started, by throwing
 3-step etch-and-rinse TEGDMA/  All patients were informed on the   cavities a thin metallic matrix was used   an oblique layering technique using   recalls. The participants were asked   to contact the clinic immediately if any
 dice. In this way, an intraindividual comparison was possible
 HEMA-free adhesive of the system   background of the study and each   and carefully wedging was performed   selected resin composite instruments   at their next visit and at all recalls if   discomfort occur.
 3.
 Results
 of the adhesive systems.
 was compared with a HEMA-free   participant provided informed consent   with wooden wedges (Kerr/Hawe   (Hu Friedy). Every increment was light   they had experienced symptoms in   STATISTICAL ANALYSIS
 After rinsing of the cavities with water, application of the
 1-step self-etch adhesive. The null   to participate in the study. The study   Neos, Switzerland). No Ca(OH)2base   cured for 20–40 s. After checking the   the region of the experimental teeth   The characteristics of the restorations
 respective adhesive was performed according to the manu-
 Three molar teeth (1 cmf, 3 ASE) showed post-operative sen-
 hypothesis tested was that the   design followed the requirements   or other base material was used.   occlusion/articulation and contouring   The caries risk of each participant   are described by descriptive statistics
 facturer’s instructions (Table 2). Curing was performed with
 sitivity during the first 3 weeks for temperature changes and
 adhesives showed similar clinical   outlined in the CONSORT 2010   The cavities in each individual pair   with finishing diamond burrs, the final   and their parafunctional habits   using cumulative relative frequency
 a well controlled light curing unit for at least 10 s (Astralis 7,
 occlusal forces. Two male patients with 2 pair of restorations
 performance when used with the   statement. All participants were   were randomly distributed to the two   polishing was performed with the   activity at baseline and during   distributions of the scores. The
 Vivadent; Demetron light meter, Kerr, Orange, CA, USA). The
 (2P, 2M) could not be evaluated during the whole 6 year follow
 1-step self-etch adhesive.  informed on the background of the   test adhesives, before the operative   Shofu polishing system (brownie).  the follow ups was estimated by   experimental and control restorative
 low shrinkage resin composite (els, Saremco) was applied in
 up due to death of both participants during the third and fifth
 all cavities in layers of maximally 2–3 mm with if possible,
 year, respectively, of the follow up. After 6 years, 135 restora-
 Materials and methods  study, which was approved by the   procedure started, by throwing   EVALUATION  treatingclinician by means of clinical   techniques were compared intra-
 ethics committee of the University of
                                                                                  individually with the non parametric
                                             and socio-demographic information
 dice. In this way, an intra individual
        The restorations were blindly
 an oblique layering technique using selected resin compos-
 tions were evaluated.
 EXPERIMENTAL DESIGN  Umeå (Dnr 07-152M).Reasons for   comparison was possible of the  the 6  evaluated and scored by using   routinely available at the annual   Friedman two-way analysis of variance
 ite instruments (Hu Friedy). Every increment was light cured
 Twenty-one Class II molar restorations failed during
                                                                                     47
 for 20–40 s. After checking
 The study was a randomized  the occlusion/articulation and con-  years (15.6%),  adhesive systems. After rinsing of the   slightly modified US Public Health   clinical examinations, e.g. incipient   test  .
 placement of the resin composite  8 cmf/els (11.4%) and 13 ASE/els (20.0%). This
 touring with finishing diamond
 controlled prospective trial. In an  burrs, the final polishing was  resulted in  cavities with water, application of the   Service criteria at base-line (after   caries lesions, former caries history,
 restorations were carious lesions,  annual failure rates (AFR) of 1.9% and 3.3%, for cmf
 performed with the Shofu polishing system (brownie).
 intra-individual comparison each   fracture of old fillings or replacements   respective adhesive was performed   performance of the restorations) and   frequency, dietary habits, oral hygiene,   Results
 and AES respectivelly and a significant difference in overall
 participant received one pair of   due to aesthetic or other reasons. No   according to the manufacturer’s   then yearlyduring the 6 year follow up   medications, salivary properties and   Three molar teeth (1 cmf, 3 ASE)
 durability between the two adhesives (p < 0.001).
 2.3.
 similar sized Class II resin composite   Class I cavities were included because  failure frequencies, years of failure and  (Table 3)  . During the evaluations,   symptoms related to bruxing activity   showed post-operative sen-
 instructions (Table 2). Curing was
 Evaluation
                44
 The cumulative
 performed with a well controlled light
 reasons for failure
 restorations. The two restorations in   of the relative good durability of these  are shown in Table 4. The scores at baseline,  the evaluators had neither knowledge   45,46 . All patients were informed about   sitivity during the first 3 weeks for
 3 and 6 years for the evaluated restorations are given as rel-
 each pair were performed with the   restorations. Operative procedures   curing unit for at least 10 s (Astralis   of which studythe evaluated RC   the follow up evaluations according   temperature changes and occlusal
 The restorations were blindly evaluated and scored by using
 slightly modified US Public Health Service criteria at base-  ative cumulative frequencies in Table 5. The main reason for
 line (after performance of the restorations) and then yearly  failure was resin composite fracture (9), followed by a combi-
 during the 6 year follow up (Table 3) [44]. During the evalua-  nation of resin fracture/secondary caries (4) and cusp fracture
 tions, the evaluators had neither knowledge of which study  (4). Eleven of the failures were observed in male and ten in
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