Longevity and Reasons For Failure of Sandwich and Total-Etch Posterior Composite Resin Restorations
Longevity and Reasons For Failure of Sandwich and Total-Etch Posterior Composite Resin Restorations
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Longevity and Reasons for Failure of Sandwich and
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Total-etch Posterior Composite Resin Restorations
Niek J. M. Opdama/Ewald M. Bronkhorsta/Joost M. Roetersb/Bas A. C. Loomansa
      Purpose: To investigate longevity and reasons for failure of Class II posterior composite restorations (PCRs) placed
      with or without a lining of glass-ionomer cement.
      Materials and Methods: Four hundred fifty-eight Class II PCR placed in 248 patients (110 male, 138 female, age 18
      to 80) by two dentists in a general practice between 1988 and 1997 were retrospectively examined from the patient
      files. The restorations were placed either with a total-etch technique or with a resin-modified glass-ionomer lining
      placed on the dentin. Items recorded were date of placement, date of last check-up visit, tooth number, and restored
      surfaces. Date of replacement and reason for failure of the PCR was recorded. A restoration was clinically acceptable
      when still in function and acceptable at the last check-up visit. Additionally, the caries risk for each patient was esti-
      mated by the treating clinician. Life tables and Kaplan-Meier curves were used to express survival rates. A Cox regres-
      sion was applied to assess the influence of variables on survival.
      Results: Three hundred seventy-six total-etch PCRs and 82 PCRs with a lining were investigated. After 9 years, sur-
      vival percentages of 88.1% for total-etch restorations and 70.5% for restorations with a resin-modified glass-ionomer
      lining were found. The most important reasons for failure were fracture and caries. Predominantly, failures started oc-
      curring after 3 to 4 years of clinical service. Results of the Cox regression show that the presence of a lining and high
      risk for caries significantly increased the failure rate of the restorations.
      Conclusion: PCRs placed with a resin-modified glass-ionomer lining clinically showed more frequent fractures than
      PCRs placed with a total-etch technique.
Keywords: composite, glass ionomer, lining, longevity, clinical, Class II, restrospective, failure, sandwich.
J Adhes Dent 2007; 9: 469-475. Submitted for publication: 14.07.06; accepted for publication: 11.07.07.
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A lining with a low modulus of elasticity, such as a glass-         I and II composite resin restorations placed between 1988
ionomer cement, is expected to act as a stress-absorbing lay-       and 2002.19                                       ss e n z
er and to compensate for polymerization shrinkage stress.9             From this database, all Class II composite resin restora-
This elastic layer concept was introduced in the early 90s,         tions placed between 1988 and 1997 according to one of
and several in vitro studies have shown that the application        the two following protocols were selected:
of a lining might be advantageous to reduce microleakage
around Class II composite resin restorations,5,11,18 while oth-     1. Restorations in which a closed-sandwich technique was
er studies failed to demonstrate a positive effect.1,7 Anoth-          applied. A layer of RMGI lining cement – either Vitrebond
er advantage of glass-ionomer cement might be the pres-                (3M ESPE; St Paul, MN, USA) or GC lining (GC; Tokyo,
ence of fluoride, which may contribute to a reduction of sec-          Japan) – was placed in a thin layer on the entire dentin
ondary caries. However, a systematic review on clinical stud-          surface followed by etching the cavity walls with 38%
ies with glass-ionomer cement restorations failed to find ev-          phosphoric acid for 15 s, rinsing, and drying. Then the ad-
idence of this effect,22 and no clinical studies on the pres-          hesive resin (Clearfil Photo Bond, Kuraray; Osaka, Japan)
ence of secondary caries in relation to posterior composite            was applied, gently air dried, and cured for 10 s. The com-
resin restorations with and without a glass-ionomer lining             posite resin (Clearfil Photo Posterior, Kuraray) was inject-
are available.                                                         ed into the cavity and placed and cured in increments.
    A possible disadvantage of the application of a lining ce-      2. Restoration in which a total-etch technique was applied.
ment with its low modulus of elasticity is a weakening effect          38% phosphoric acid was placed simultaneously on
on the strength of the overlying composite resin. In vitro             enamel and dentin for 15 s. Then the cavity was rinsed
studies have shown that posterior composite restorations               and air dried before application of the dentin primer
placed without a liner are significantly stronger than those           (Clearfil SA primer, Kuraray), which was carefully dried.
placed with a liner of glass-ionomer cement.3 Another in vit-          Then the adhesive resin (Clearfil Photo Bond, Kuraray)
ro study demonstrated that a layer with a low E-modulus ma-            was applied, gently air dried, and cured for 10 s. The
terial placed between two high E-modulus materials (tooth              same composite resin (Clearfil Photo Posterior, Kuraray)
and composite resin) leads to a concentration of forces in             was injected into the cavity and placed and cured in in-
the elastic layer when the tooth is loaded.24 Furthermore, in          crements.
vitro studies showed that in restorations with a lining of a low
E-modulus material, the microleakage increased after sub-               Four hundred fifty-eight Class II restorations were placed
jecting the restorations to loading.4,10 In a clinical situation,   according to these protocols in 248 patients (110 male, 138
this could result in restorations placed with a lining being        female, age between 18 and 80 years). The Class II restora-
more sensitive to fatigue after repeated loading. This could        tions varied from rather small box-type Class II restorations
lead to higher clinical failure of the restorations either due      in primary proximal caries to large cusp-replacing restora-
to fracture or caries.                                              tions. The decision to use a glass-ionomer cement as lining
    To mention another confounding factor, the development          did not depend on the size of the preparation, but rather on
of secondary caries also depends on whether the patient is          the period in which restorations were placed, as in the years
a caries-risk or non-risk patient. This probably influences the     1990 to 1995, it gradually became “state of the art” to use
survival and type of failure of sandwich or total-etch restora-     the total-etch technique instead of the sandwich technique.
tions, as the presence of glass ionomer might contribute to         No calcium hydroxide lining was applied in the cavities. The
lessening failures due to secondary caries. A simple method         restorations were placed by one of two operators. The first
has been described to classify patients according to the ex-        operator was an experienced dentist who graduated in
pected caries risk,17,23 which has been used in another clin-       1980. He placed 360 restorations from 1988 to 1997. The
ical study.13                                                       second operator started in the practice in 1992 immediate-
    Until now, no long-term data have been available which          ly after graduation, and placed 98 restorations from 1992
compare longevity and reasons for failure for composite             to 1997.
resin restorations placed with a sandwich or total-etch tech-           From the files, the date of placement of the restorations
nique. The aim of this retrospective clinical study was to in-      and the date of the last check-up visit were recorded up to
vestigate differences in longevity and the reasons for failure      December 2005. Other recorded items were the operator in-
of Class II posterior composite restorations placed with or         volved, the tooth number, and the restored tooth surfaces.
without a lining of glass-ionomer cement in patients with a         If a restoration was replaced, the date of replacement and
low or high caries risk.                                            reason for failure of the restoration were recorded. When a
                                                                    restoration was still in function at the date of the last check-
                                                                    up visit in the practice, the restoration was considered to be
MATERIALS AND METHODS                                               clinically acceptable. The examination during the last check-
                                                                    up visit was done by one operator (operator 1).
In a previous longitudinal study, amalgam and composite                 Teeth that were restored as a pretreatment to serve as an
restorations placed in a general practice by two operators          abutment tooth for crowns were excluded from the study.
were retrospectively evaluated from the patient files. In-          Whenever a tooth received a new restoration without affect-
cluded in the study were files from all patients who regular-       ing the existing restoration, eg, when caries on a distal sur-
ly attended the dental practice for check-ups and follow-up         face of a tooth with a mesial box restoration was restored
treatment in 2002. This resulted in a large database of Class       with a distal box-type restoration, this was not considered as
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              Table 1a Size of the restorations according to number of treated surfaces                                      e ss e n z
                                                  2-surface         3-surface        4/5-surface               Total
                Total-etch restorations                138               166                 72                376
                Sandwich restorations                   40                33                  9                 82
                                  Total                178               199                 81                458
a failure. However, endodontic treatment, replacement due            “operator” was added as a co-variable to the multivariate
to pain and extraction, although not necessarily related to          model. By doing so, the estimates of the explicatory vari-
the restorations, were always considered failures. In the            ables is corrected for potential operator effects. To eliminate
same way, a cusp fracture next to an existing restoration, al-       variables with no significant effect on restoration survival, a
though often repaired without a total replacement of the             backward regression procedure was applied. Cox regression
restoration, was considered to be related to the existing            was applied to assess the influence of these variables on
restoration and considered a failure.                                restoration survival. Since for some patients more than one
    Additionally, the caries risk for each patient was estimat-      restoration was included in the study, the condition stating
ed retrospectively by the treating clinician (the first operator)    that all measurements are independent was violated. There-
by means of clinical and sociodemographic information rou-           fore, the results of the Cox model were checked with an ex-
tinely available at the annual clinical examinations, eg, in-        tended Cox model, containing a gamma frailty term. This last
cipient caries lesions and former caries history.12                  model is implemented using the statistical software R (Lan-
    The data set was statistically analyzed using SPSS soft-         guage and Environment for Statistical Computing, Founda-
ware. The analysis consisted of two parts. The first part had        tion for Statistical Computing; Vienna, Austria).
a descriptive character and was used to describe the mate-              Because it was possibly a confounding factor that in the
rial and allow for easy comparison with existing literature on       period in which both sandwich and total-etch restorations
this subject. For this purpose, cross tabs were made to il-          were placed, the selection made by the dentist could have
lustrate the various types of restorations made; life tables         played a role (eg, difficult cases preferably sandwich, easy
were used to calculate survival rates and annual failure             cases total-etch), a Cox regression was also used to compare
rates (AFR) according to the formula                                 data for total-etch restorations placed in the period 1994 to
                                                                     1995 with those placed in 1996, when the sandwich tech-
                     √ 1 - AFR
                     k
                P=                                                   nique was no longer used.
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Table 2 Number of clinically acceptable and failed restorations and reasons for failure, related to caries risk
patients                                                                                                             se nz
 Total-etch restorations                                      high caries risk                 low caries risk              total nr. total-etch
                                                                %      n       n             %        n        n              %           n
 clinically acceptable                                       78%     102                   94%      231                       89%        333
 failed – caries                                             16%       21                   2%         5                       7%         26
 failed – fracture                                            1%         2                  2%         4                       1%           6
                                fracture of restoration                        1                               3
                                      fracture of tooth                        1                               1             3%           11
 Other reasons for failure                                   2%      5                      2%         6
                                             pain/endo                         1                               4
                                              extraction                       4                               1
                                       loss of retention                       0                               0
                                               unknown                         0                               1
 Total                                                               130                            246                                 376
 Closed sandwich restoration                                 high caries risk              low caries risk                  total nr. sandwich
                                                             %       n            n        %         n           n            %          n
 clinically acceptable                                       65%     20                    55%       28                       59%        48
 failed due to caries                                        26%      8                     6%        3                       13%        11
 failed due to fracture                                      10%      3                    29%       15                       22%        18
                                fracture of restoration                           2                               5
                                      fracture of tooth                           1                              10
 Other reasons for failure                                   0%       0                    10%        5                      6%         5
                                             pain/endo                            0                              2
                                              extraction                          0                              1
                                       loss of retention                          0                              1
                                               unknown                            0                              1
 Total
                                                                      31                              51                                82
          Caries risk of patients              high risk   low risk       high+low risk   high risk   low risk       high+low risk
          Annual failure rate                    2.7%       0.8%             1.4%          2.8%        4.4%              3.8%
          % in service after 9 years             78%        93.3%            88.1%         77.0%      66.5%             70.5%
    The survival rates and annual failure rates after 9 years              results for the final Cox regression are shown in Table 4. All
are listed in Table 3. After 9 years, a survival percentage of             included variables showed statistical significance. Espe-
88.1% for the total-etch restorations was found, compared                  cially a sandwich restoration placed in a high caries-risk pa-
to 70.5% for the sandwich restorations. The Kaplan-Meier                   tient significantly increased the failure rate of the restora-
survival curves for both groups of restorations are shown in               tions. The odds ratio of 4.08 indicates that, while correcting
Fig 1.                                                                     for the other variables in the regression model, sandwich
    Figures 2a and 2b present the relation between the time                restorations have a failure risk about four times as high as
and type of failure. The most important reasons for failure                total-etch restorations. Smaller differences were found be-
are: fracture of the tooth and/or restoration and caries. Pre-             tween operators, number of treated surfaces, and between
dominantly, these failures started occurring after 3 to 4                  molar and premolar teeth.
years of clinical service.                                                    The total-etch restorations placed in 1996 did not per-
    The results of the extended Cox model including a gam-                 form significantly differently from those placed in the period
ma frailty term were identical to that of the basic Cox mod-               1994 to 1995 (Cox regression corrected for number of ser-
el. This implied that the clustering of some of the restora-               vices: Exp (B) = 1.264, p = 38.3). Thus, selection made by
tions did not influence the results of the Cox regression. The             the dentist was excluded as a possible confounding factor.
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years years
Fig 2a Type of failure and functional time of each failed total-     Fig 2b Type of failure and functional time of each failed sand-
etch restoration (43 failed of 376 placed restorations).             wich restoration (34 failed of 82 placed restorations).
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DISCUSSION                                                            It is often suggested that glass-ionomer cement should
                                                                   lead to a prevention of secondary caries. Moreover,          nz
                                                                                                                        ssa elining
In the present study, the longevity of posterior composite         of RMGIC is considered to act as an elastic layer, which
restorations placed with either the total-etch technique or a      should improve adaptation of the restoration and compen-
sandwich technique with a resin-modified glass-ionomer lin-        sate for polymerization stress. The results of this study do
ing was compared. The retrospective examination of well-           not support either assumption. The occurrence of sec-
kept and detailed patient files enabled the evaluation of a        ondary caries appeared to depend on the caries risk level
large number of restorations placed in a general dental prac-      of the patient and not on the presence or absence of glass-
tice. Randomized clinical trials have the advantage of stan-       ionomer cement. This finding is in accordance with a sys-
dardization of methods and calibration of the operators, al-       tematic review that failed to support the statement that
lowing a more reliable comparison between different treat-         glass-ionomer cement has a cariostatic effect under clini-
ment options. However, such a study design does not reflect        cal conditions.22
the situation in a general dental practice, as patients are se-        The results of the present study support the assumption
lected and operators are aware of the fact that restorations       made in the introduction that the presence of a lining ce-
will be evaluated. This might explain why the results of ran-      ment reduces the fracture resistance of a restoration, as a
domized clinical studies are often better than those of ret-       significantly higher failure rate was found for these type of
rospective studies. In the present study, a variety of patients    restorations in the present study. The increase in failure of
was included, thus, high-caries risk patients were also in-        the sandwich group was mainly due to fracture either of the
cluded in the study population. According to the general           restoration or of the tooth, or both. Clinical findings in oth-
dentist who treated the patients in the period of the study,       er studies on sandwich restorations are in accordance with
161 restorations were placed in high-risk patients while the       the present findings. In one study, the 6-year results show
other 297 were placed in low-risk patients.                        an increasing number of failures of relative large open-
    The results of the present study show that in caries-risk      sandwich restorations due to fracture, compared to the 3-
patients, the failure rate of restorations was higher than in      year results.2,12 One study on small closed-sandwich Class
non-risk patients. For the total-etch group, almost no failures    I and II restorations reported a survival rate of 83% after 8
due to caries were seen in the low-risk group. Hence, the low      years, which is in accordance with the sandwich restora-
annual failure rate of 0.8% that was found in this group in-       tions in our present study. In that study as well, the majori-
dicates that the selected composite and adhesive system            ty of failures was related to fracture and partial loss of the
are of high quality and both operators performed well. The         restoration.15 A 17-year clinical trial on closed-sandwich
difference in annual failure rate between low-risk and high-       restorations showed an acceptable survival rate, but the
risk patients and the finding that the main reasons for fail-      most important reason for failure was fracture, while caries
ure did not appear before 3 to 4 years of clinical service (as     was seldom found.8 It can be speculated that the restora-
expressed in Figs 2a and 2b) is remarkable. Today, many            tions in that study were placed in patients with low caries
new composite resins and adhesive systems are put on the           risk. Because no direct comparison was made in any of
market as an improvement of previous products. These new-          these studies between sandwich- and total-etch restora-
er products are mostly tested in clinical studies carried out      tions, the role of glass ionomers in the fracture behavior re-
in university clinics, largely with observation times less than    mained unclear.
3 years. The moment that long-term data become available               Based on the results of the present study, the elastic lay-
and materials are clinically proven, these materials are often     er concept should be viewed with scepticism. It is more like-
classified as outdated by the manufacturers and replaced by        ly that a shock-absorbing layer underneath the restoration
an “advanced formula”.                                             facilitates the onset of restoration failure in the long run.
    Recent clinical studies on two new tooth-colored materi-       Whether this also occurs with other elastic layers, such as
als, Solitaire and Ariston, showed a considerable failure rate     other glass-ionomer cements, thick adhesive resins, flow-
of 21% for Solitaire after 3 years and 17% for Ariston after 2     able composites or compomers, remains unclear and
years.14,19 Based on the results, the authors advised waiting      should be investigated. Meanwhile, in the present study the
for at least the two-year clinical data before bringing new ma-    most rigid combination of a thin adhesive resin with a hybrid
terials on the market. The results of the present study show       composite resin showed excellent clinical performance over
that with materials that have been on the market for more          a 10-year period.
than 15 years, excellent results can be obtained in general
dental practice. Most of the failures did not occur before 4
years of clinical service, and the survival of the restorations    CONCLUSIONS
was significantly influenced by the caries risk level of the pa-
tients in the study. The present ADA guidelines require an         1. Total-etch restorations placed with a highly filled hybrid
18-month period of clinical service for acceptance of a new           composite resin showed a higher clinical survival than
all-purpose composite resin. Based on the findings in the             closed-sandwich restorations using a lining of RMGIC,
present study, the authors consider this period to be far too         due to a lower fracture rate.
brief to detect possible shortcomings of dental materials,         2. Fracture and secondary caries, the most important rea-
and suggest a period of at least 4 years for evaluation of new        sons for failure, mostly occurred after a period of more
materials.                                                            than three years.
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                                                                                       14.   Ernst CP, Martin M, Stuff S, Willershausen B. Clinical performance    of a
                                                                                             packable resin composite for posterior teeth after 3 years. Cline
3. Doubt should be cast on the alleged advantages of the
   elastic layer underneath a composite resin restoration.                                   2001;5:148-155.
                                                                                                                                                             Oral
                                                                                                                                                                  e nz
                                                                                                                                                               ssInvest
                                                                                       15. Gaengler P, Hoyer I, Montag R. Clinical evaluation of posterior composite
                                                                                           restorations: the 10-year report. J Adhes Dent 2001;3:185-194.
                                                                                       16. Hickel R, Manhart J. Longevity of restorations in posterior teeth and rea-
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