827566

research-article2019
JDRXXX10.1177/0022034519827566Journal of Dental ResearchRisk Factors in Restorative Dentistry

Research Reports: Clinical

Journal of Dental Research
2019, Vol. 98(4) 414­–422
Risk Factors for Dental Restoration © International & American Associations
for Dental Research 2019

Survival: A Practice-Based Study Article reuse guidelines:

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DOI: 10.1177/0022034519827566
https://doi.org/10.1177/0022034519827566
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M. Laske1, N.J.M. Opdam1, E.M. Bronkhorst1, J.C.C. Braspenning1,

and M.C.D.N.J.M. Huysmans1

Abstract
To improve patient dental care, it is necessary to identify possible risk factors for the failing of restorations. This practice-based cohort
study investigated the performance and influence of possible risk factors at the level of the practice, patient, tooth, and restoration on
survival of direct class II restorations. Electronic patient files from 11 Dutch general practices were collected, and 31,472 restorations
placed between January 2015 and October 2017 were analyzed. Kaplan-Meier statistics were performed; annual failure rates (AFRs)
were calculated; and variables were assessed by multivariable Cox regression analysis. The observation time of restorations varied from
0 to 2.7 y, resulting in a mean AFR of 7.8% at 2 y. However, wide variation in AFRs existed among the operators, varying between
3.6% and 11.4%. A wide range of patient-related variables is related to a high risk for reintervention: patient age (elderly: hazard ratio
[HR], 1.372), general health (medically compromised: HR, 1.478), periodontal status (periodontal problems: HR, 1.207), caries risk and
risk for parafunctional habits (high: HR, 1.687), restorations in molar teeth (HR, 1.383), restorations placed in endodontically treated
teeth (HR, 1.890), and multisurface restorations (≥4 surfaces: HR, 1.345). Restorations placed due to fracture were more prone to fail
than restorations placed due to caries. When patient-related risk factors were excluded, remaining risk factors considerably changed in
their effect and significance: the effect of operator, age of the patient, and endodontic treatment increased; the effect of the diagnosis
decreased; and the socioeconomic status became significant (high: HR, 0.873). This study demonstrated that a wide variation of risk
factors on the practice, patient, and tooth levels influences the survival of class II restorations. To provide personalized dental care, it is
important to identify and record potential risk factors. Therefore, we recommend further clinical studies to include these patient risk
factors in data collection and analysis.

Keywords: clinical study, risk assessment, dental caries, bruxism, dental restoration failure, cohort studies

Introduction (Opdam et al. 2014; van de Sande et al. 2016). Besides patient-
related factors, dentist factors, such as personal skills and treat-
Knowledge about factors influencing survival of direct class II ment decisions (Laegreid et al. 2014; Laske et al. 2016a;
restorations can improve patient care. Most clinical studies Collares et al. 2017) and health insurance policies (Khalaf et al.
published on dental restorations aimed to evaluate the perfor- 2014), may play a significant role in the survival of restora-
mance of new materials and techniques, often in a selected tions placed in general practice as well.
patient group from university clinics, with underpowering and To improve patient dental care, it is necessary to identify
too short observation times identified as possible problems possible risk factors for the failing of restorations. Therefore,
(Opdam et al. 2018). Systematic reviews based on these type of we set up a study to investigate a large data set of restorations
studies resulted in excellent survival rates for composite resto- placed in a general practice environment and general popula-
rations (Heintze and Rousson 2012). tion, but most important, it included a wide range of possible
Furthermore, in the last decade, there is increasing support variables on the patient level. There were reports published on
for acknowledging that materials and their properties are not these big data (Lucarotti et al. 2005; Laske et al. 2016a; Raedel
the decisive factors in restoration survival (Demarco et al.
2012). Clinical retrospective and practice-based studies were 1
Department of Dentistry, Radboud Institute for Health Sciences,
published showing that patient-related factors, such as caries
Radboud University Medical Centre, Nijmegen, the Netherlands
risk and bruxism (Opdam et al. 2007; Opdam et al. 2010; van
de Sande et al. 2013) as well as socioeconomic status (SES;
Correa et al. 2013; Collares et al. 2018), are variables of main Corresponding Author:
M. Laske, Department of Dentistry, Radboud Institute for Health
importance in restoration survival. Systematic reviews includ-
Sciences, Radboud University Medical Centre, Philips van Leydenlaan
ing patient-related risk factors showed that their influence on 25, Internal Postal Code 309, PO Box 9101, 6500 HB Nijmegen, the
restoration performance is not only significant but also rele- Netherlands.
vant, demonstrating hazard ratios (HRs) from 2.5 to 8.3 Email: [email protected]
Risk Factors in Restorative Dentistry 415

et al. 2017); however, these studies were hampered by their •• When a crown was placed within 1.5 y after initial
retrospective nature and their failure to include possible risk direct restoration, this restoration likely served as a base
factors for restoration performance in the analysis, as general for a crown placement and was censored.
dental practitioners (GDPs) did not include these factors in the •• When a mesial occlusal restoration was placed as the first
patient files. restoration and the intervention treatment was a distal
The growing tendency toward more personalized care in occlusal restoration, analysis for the initial restoration
dentistry (Garcia et al. 2013) and the public demand for trans- was censored, as many mesial and distal occlusal restora-
parency and shared decision making (Main and Adair 2015) tions are likely independent restorations (box type).
drive the need for GDPs to extend information in electronic
patient files (EPFs) as well as identify risk factors on the
patient level. In the Netherlands, a country where almost all Independent Variables
dental practices use EPFs and patients are loyal to their GDPs, On a practice level, the individual practitioner who placed the
it was possible to analyze restoration performance for identifi- restoration was coded. On a patient level, sex, age, SES, gen-
cation of possible risk factors for survival. eral health score, periodontal status, oral hygiene (based on the
The aim of this study was to investigate the influence of amount of plaque: poor/average/good), caries risk (low/high),
possible risk factors—at the level of practice, patient, tooth, and presence of parafunctional habits (yes/no), and the presence of
restoration—on the longevity of direct class II restorations. a removable denture (yes/no) were recorded. Patients were
divided into 6 age groups. SES scores were provided by the
Dutch Central Office for Statistics based on zip code; 3,546
Materials and Methods
areas were ranked; and patients were categorized into low,
Inclusion and Data Collection medium, and high SES. General health status was based on the
classification of the American Society of Anesthesiologists
Data from EPFs of general practices joining a practice-based (Doyle and Garmon 2017): healthy (score 1), medically com-
research group were the basis of this cohort study. Data on promised (score 2), and severely medically compromised
direct class II restorations placed between January 1, 2015, and (score ≥3). Periodontal status was based on the Dutch
January 10, 2017, were digitally extracted, transformed into Periodontal Screening Index (Van der Velden 2009) resulting
anonymized Excel files, and sent to the researchers with an in scores A (bleeding on probing and/or calculus), B (pockets 4
application designed by the involved software firm (Exquise). to 5 mm without recession), and C (pockets 4 to 5 mm with
Data validation was performed by visiting all practices and recession or pockets ≥6 mm). High caries risk was scored
checking 200 randomly selected patient files on data transition according to the presence of active lesions, number of new car-
failures. Exclusion criteria were as follows: ies lesions (≥1 new caries lesions in the last year), and frequent
sugar consumption. Low risk was assigned to patients without
•• Practitioners with <250 restorations active lesions and new caries lesions (last restoration due to
•• Patients not visiting for check-ups at least once a year caries ≥2 y ago) and with sufficient plaque control (Mettes
•• Restorations with missing data on restorative materials et al. 2010). Due to the lack of guidelines and protocols, the
or patients’ zip codes assessment of parafunctional habits was based on the follow-
ing question: Is there nonphysiologic wear visible on teeth or
The study design and protocol were approved by the local eth- restorations? This item also considered indicators such as
ics committee (METC; CMO Arnhem-Nijmegen file exposed dentin, distinctive wear facets, fractures of restora-
2015-1565). tions or teeth, and hypertrophic chewing muscles.
On the tooth level, tooth number, number of restored sur-
Outcome Parameters faces, existing endodontic treatment (yes/no), applied restor-
ative material, adhesive system used, and diagnosis for placing
Dates of class II restoration placement, last check-up visits, restorations were recorded. The dental practitioners were
and reintervention were recorded. When no intervention was invited by the software to select the best matching diagnosis
performed on a restoration, it was considered successful and from a list:
censored at the last check-up date. When a new restoration was
placed in the same tooth, including ≥1 surfaces of the previous •• Caries on unrestored surface
restoration, this was defined as an intervention on the restora- •• Caries on previously restored surface
tion and considered a failure. Regardless of the diagnosis, •• Fracture of the tooth or restoration
extraction, endodontic, and prosthetic treatments were consid- •• Wear of the tooth or restoration
ered as failures. Exceptions were as follows: •• Fracture prevention
•• Restoration after endodontic treatment
•• Restorative interventions in the first month were ignored, •• Aesthetic demands
and initial restoration observation was censored. •• Orthodontic retainer
416 Journal of Dental Research 98(4)

Table 1.  Diagnoses of the First Performed Interventions. variables using a full conditional model with 50-fold multiple
First Intervention: Diagnosis Interventions, n (%)
imputation. Pooled results from the analyses on the 50 imputed
data sets resulted in the data set for further statistical analysis.
Direct restoration 2,004 (67.8) In sum, 61.1% of restorations had an incomplete or partial
 Caries 999 (33.8) EPF; however, the missing information was limited to the fol-
  Fracture of tooth or restoration 531 (18.0)
  Wear of tooth or restoration 176 (6.0)
lowing patient-related variables: American Society of
  Dislodged restoration 144 (4.9) Anesthesiologists score, Dutch Periodontal Screening Index,
  Insufficient contact point or margin 86 (2.9) oral hygiene, caries risk, and risk for parafunctional habits.
 Othera 68 (2.3) To explore impact of risk factors on restoration survival, a
Endodontic treatment 678 (23.0) multilevel Cox regression analysis was conducted with cluster-
Crown 75 (2.5) ing of data for patients with multiple restorations. The method
  Large direct restoration 36 (1.2)
described by Chuang et al. (2001) to produce statistically valid
  Endodontically treated tooth 16 (0.5)
  Crown replacement 13 (0.4)
standard errors for the estimates of survival was performed.
  Abutment tooth bridge or removable denture 10 (0.3) To investigate the impact of patient-related factors on direct
Extraction 199 (6.7) restoration survival, the Cox regression was repeated with the
 Caries 37 (1.3) individual patient characteristics excluded from the analysis,
 Periodontitis 31 (1.0) except for the age factor. When the P value of an independent
  Periodontitis apicalis 62 (2.1) variable in both Cox regressions met the significance level of
  Fracture (vertical), tooth or restoration 54 (1.8)
<5%, the percentage difference between the HRs was calcu-
 Otherb 15 (0.5)
Total 2,956 (100) lated by the following formula: y = [(x/z) – 1] × 100, in which
y expresses the percentage difference, x is the HR of the sig-
a
Aesthetics, orthodontic retainer, trauma, cracked tooth, or fracture nificant independent variable in the multiple Cox regression
prevention. with the patient factors excluded, and z is the HR of the signifi-
b
Deviating position, orthodontic treatment, or financial problems.
cant independent variable in the multiple Cox regression with
the patient factors included.
•• Dislodged restoration Chi-square tests were used (P ≤ 0.05) to calculate the rela-
•• Insufficient proximal contact tion between diagnosis for placing a restoration and the patient’s
•• Poor marginal adaptation risk profile.
•• Trauma
•• Cracked tooth
Results
GDPs were completely free to use restorative materials at their Restorations placed by 22 GDPs (13 men, 9 women) in 11
discretion. From January 12, 2015, until January 2, 2017, the practices were included: mean age, 44.4 y (95% CI, 31.7 to
Clearfil Majesty ES-2 hybrid resin composite, Clearfil SE 57.1); mean time since graduation, 17.2 y (95% CI, 6.7 to
Bond, and Clearfil Protect Bond (all from Kuraray Noritake) 27.7). In advance, restorations were excluded due to missing
were provided to the practitioners for free. Treatments were zip code (n = 5), missing data on restorative material (7,697
regularly carried out with the assistance of a dental nurse, and restorations), no yearly follow-up (378 patients), or placement
only a few practitioners used rubber dam isolation during res- by practitioners who performed <250 restorations (714 restora-
toration placement. tions). Included in the final data set were a total of 31,472 class
II restorations placed in 14,909 patients (7,377 male; 7,532
female; mean age, 44.1 y). The mean number of included res-
Statistical Analysis torations per patient was 2.11 (95% CI, 1.34 to 2.88). The
Statistical analyses were performed with SPSS 22 (IBM) and R observation period varied between 0 and 33 mo (mean obser-
3.4.0. Longevity of restorations was explored with survival vation time, 9.2 mo). The collected data from these patients
tables and Kaplan-Meier graphs. Based on the survival tables, were considered homogeneous and suitable for multivariable
mean annual failure rates over 2 y (AFR2) were calculated regression analysis.
according to the following formula: AFR2 (%) = 1 – 2 x × 100, The mean calculated AFR2 was 7.8% (95% CI, 7.6% to
in which x equals level of survival after 2 y. The use of routine 8.0%), and survival was 85.1% after 2 y. Table 1 shows the
data implies that data are missing, especially for those items diagnoses for the intervention performed first. New direct res-
that were relatively new to GDPs, such as specific risk indica- toration placement due to caries was the most common inter-
tors. Performing analyses on complete cases only is likely to vention, followed by an endodontic treatment.
result in biased results (Graham and Donaldson 1993). As there Table 2 describes the results of the descriptive statistics;
is no indication that the chance of information being missing is annual failure rates (after 2 y); the adjusted multivariable
dependent on the missing data, we assumed that the “missing regression analysis for the practice-, patient-, tooth-, and
at random” hypothesis is true. Under that assumption, we restoration-related variables; and the regressions analysis with
applied multiple imputation to deal with missing independent the exclusion of individual patient factors.
Risk Factors in Restorative Dentistry 417

Table 2.  Statistical Analysis of Practice-, Patient-, and Tooth/Restoration-Related Variables on Restoration Survival.

Restorations, n Percentage
(%) AFR, % P Value HR1 (95% CI)a P Value HR2 (95% CI)b Difference in HRc

Practice characteristics (n = 11 practices)

Practitioners (practice_practitioner) 
 1_1 2,251 (7.2) 5.9 — 1.00 — 1.00  
 2_1 1,887 (6.0) 8.2 <0.001d 1.813 <0.001d 1.970 8.64
(1.363 to 2.413) (1.490 to 2.604)
 2_2 506 (1.6) 5.9 0.358 1.282 0.241 1.372  
(0.755 to 2.175) (0.809 to 2.326)
 3_1 1,100 (3.5) 5.6 0.124 0.759 0.932 0.985  
(0.533 to 1.073) (0.706 to 1.376)
d d
 4_1 735 (2.3) 11.6 0.007 1.734 0.005 1.773 2.25
(1.163 to 2.586) (1.188 to 2.647)
 4_2 806 (2.6) 7.5 0.039d 1.448 0.010d 1.573 8.67
(1.018 to 2.059) (1.113 to 2.223)
 5_1 2,291 (7.3) 5.7 0.376 1.156 0.062 1.344  
(0.838 to 1.596) (0.986 to 1.832)
 5_2 1,777 (5.6) 5.9 0.983 1.004 0.325 1.189  
(0.705 to 1.428) (0.842 to 1.678)
d d
 6_1 4,490 (14.3) 10.7 0.004 1.445 <0.001 1.520 5.19
(1.123 to 1.858) (1.182 to 1.953)
 6_2 470 (1.5) —e 0.008d 1.908 0.002d 2.098 9.92
(1.182 to 3.081) (1.301 to 3.381)
 6_3 2,006 (6.4) 9.9 <0.001d 2.227 <0.001d 2.405 7.97
(1.664 to 2.981) (1.804 to 3.206)
 7_1 877 (2.8) 11.7 0.004d 1.727 0.003d 1.754 1.56
(1.186 to 2.514) (1.217 to 2.527)
d d
 7_2 1,347 (4.3) 10.8 <0.001 2.205 <0.001 2.221 0.72
(1.627 to 2.989) (1.644 to 3.000)
 8_1 657 (2.1) 8.6 0.463 1.162 0.571 1.119  
(0.778 to 1.733) ( 0.758 to 1.653)
 8_2 303 (1.0) —e 0.009d 2.884 0.002d 3.246 12.54
(1.309 to 6.354) (1.522 to 6.920)
 9_1 1,252 (4.0) 7.0 0.586 1.101 0.232 1.233  
(0.778 to 1.558) (0.875 to 1.738)
d d
 10_1 3,621 (11.5) 8.5 0.041 1.373 0.035 1.384 0.84
(1.013 to 1.861) (1.023 to 1.872)
 11_1 1,475 (4.7) 3.6 0.091 0.698 0.124 0.723  
(0.461 to 1.059) (0.478 to 1.093)
 11_2 1,151 (3.7) 7.3 0.131 1.363 0.087d 1.412  
(0.912 to 2.037) (0.951 to 2.098)
 11_3 339 (1.1) —e <0.001d 4.722 <0.001d 5.061 7.16
(2.557 to 8.720) (2.769 to 9.251)
 11_4 1,299 (4.1) 4.1 0.729 0.932 0.966 0.991  
(0.624 to 1.391) (0.668 to 1.472)
 11_5 832 (2.6) 7.9 0.277 1.222 0.092 1.358  
(0.851 to 1.756) (0.951 to 1.939)
Patient characteristics (n = 14,909 patients)
Sex  
 Male 16,090 (51.1) 8.4 — — — 1.00  
 Female 15,382 (48.9) 7.1 0.171 0.932 0.064 0.910  
(0.842 to 1.031) (0.824 to 1.005)
Age group, y  
  5 to 12 610 (1.9) 6.1 — 1.00 — 1.00  
  13 to 20 3,589 (11.4) 8.1 0.069 1.236 0.020d 1.312  
(0.984 to 1.552) (1.044 to 1.650)
  21 to 30 4,681 (14.9) 8.5 0.201 1.165 0.066 1.245  
(0.922 to 1.474) (0.986 to 1.573)
  31 to 50 12,390 (39.4) 9.2 0.017d 1.314 0.002d 1.420 8.04
(1.051 to 1.644) (1.141 to 1.767)
d d
  51 to 70 8,883 (28.2) 12.5 0.043 1.247 0.002 1.447 16.06
(0.980 to 1.587) ( 1.151 to 1.820)
  71 to 96 1,319 (4.2) 14.4 0.019d 1.372 <0.001d 1.800 31.21
(1.054 to 1.786) (1.418 to 2.286)

(continued)
418 Journal of Dental Research 98(4)

Table 2. (continued)

Restorations, n Percentage
(%) AFR, % P Value HR1 (95% CI)a P Value HR2 (95% CI)b Difference in HRc

SES  
 Low 10,211 (32.4) 8.6 — 1.00 — 1.00  
 Medium 7,632 (24.3) 7.4 0.368 0.934 0.247 0.917  
(0.806 to 1.083) (0.792 to 1.062)
 High 13,629 (43.3) 7.5 0.106 0.902 0.033d 0.873  
(0.796 to 1.022) (0.770 to 0.989)
General health condition  
 (ASA)
 Healthy 16,273 (51.7) 7.1 — 1.00  
  Medically compromised 5,641 (17.9) 10.1 0.027d 1.166  
(1.018 to 1.336)
  Severe medically 488 (1.6) 13.6 0.017d 1.478  
  compromised (1.074 to 2.034)
 Unknown 9,070 (28.8)  
Periodontal condition  
 (DPSI)
  No problems (score A) 12,650 (40.2) 6.7 — 1.00  
  Mild problems (score B) 7,896 (25.1) 7.6 0.105 1.116  
(0.977 to 1.275)
  Severe problems (score C) 4,611 (14.7) 10.5 0.014d 1.207  
(1.039 to 1.402)
 Unknown 6,315 (20.1)  
Oral hygiene  
 Poor 1,692 (5.4) 12.7 — 1.00  
 Average 10,207 (32.4) 7.7 0.195 0.872  
(0.708 to 1.073)
 Good 7,894 (25.1) 7.8 0.043d 0.824  
(0.683 to 0.994)
 Unknown 11,679 (37.1)  
Presence of a removable  
 denture
 No 29,816 (94.7) 7.3 — 1.00  
 Yes 1,656 (5.3) 16.9 <0.001d 1.712  
(1.138 to 2.038)
Caries risk and  
  parafunctional habits
  Low risk without habits 5,554 (17.6) 6.0 — 1.00  
  Low risk with habits 1,754 (5.6) 8.0 0.070 1.207  
(0.985 to 1.480)
  High risk without habits 6,613 (21.0) 9.3 <0.001d 1.572  
(1.331 to 1.855)
  High risk with habits 2,143 (6.8) 11.8 <0.001d 1.687  
(1.405 to 2.026)
 Unknown 15,408 (49.0)  
Tooth and restoration characteristics (n = 31,472 restorations)
Arch  
 Mandible 14,050 (44.6) 8.3 — 1.00 — 1.00  
 Maxilla 17,422 (55.4) 7.4 0.578 0.974 0.950 1.003  
(0.886 to 1.070) (0.914 to 1.101)
Tooth type  
 Premolar 11,626 (36.9) 6.5 — 1.00 — 1.00  
 Molar 19,846 (63.1) 8.5 <0.001d 1.383 <0.001d 1.311 –5.21
(1.245 to 1.537) (1.181 to 1.456)
No. of surfaces  
 2 17,218 (54.7) 6.4 — 1.00 — 1.00  
 3 8,335 (26.5) 9.3 <0.001d 1.333 <0.001d 1.344 0.82
(1.188 to 1.496) (1.199 to 1.507)
  ≥4 5,919 (18.8) 10.0 <0.001d 1.345 <0.001d 1.366 1.61
(1.168 to 1.548) (1.188 to 1.571)

(continued)
Risk Factors in Restorative Dentistry 419

Table 2. (continued)

Restorations, n Percentage
(%) AFR, % P Value HR1 (95% CI)a P Value HR2 (95% CI)b Difference in HRc

Endodontic treatment  
 No 30,000 (95.3) 7.2 — 1.00 — 1.00  
 Yes 1,472 (4.7) 19.2 <0.001d 1.890 <0.001d 2.078 9.95
(1.600 to 2.233) (1.767 to 2.444)
Used restorative material  
  Clearfil Majesty ES-2 12,566 (39.9) 8.1 — 1.00 — 1.00  
  Clearfil APX 13,342 (42.4) 5.5 <0.001d 0.698 <0.001d 0.692 –0.79
(0.578 to 0.842) (0.574 to 0.834)
  Other composite resin 4,854 (15.4) 6.7 0.004d 0.768 0.003d 0.763 –0.69
(0.640 to 0.921) (0.636 to 0.914)
  Glass ionomer 638 (2.0) 30.0 <0.001d 4.073 <0.001d 4.395 7.91
(3.118 to 5.319) (3.416 to 5.653)
 Compomer 15 (0.1) — 0.029d 4.062 0.019d 4.224 3.98
(1.152 to 14.319) (1.273 to 14.010)
 Amalgam 57 (0.2) — 0.061 1.884 0.057 1.930  
(0.971 to 3.656) (0.979 to 3.802)
Used adhesive material  
 Photobond 8,686 (27.6) 7.3 — 1.00 — 1.00  
  SE Bond  12,645 (40.2) 8.6 0.038d 1.229 0.040d 1.224 –0.73
(1.011 to 1.493) (1.010 to 1.485)
  SE Protect 4,062 (12.9) 9.1 0.150 1.198 0.137 1.204  
(0.936 to 1.532) (0.942 to 1.539)
  Other adhesives 1,332 (4.2) 8.0 0.226 0.782 0.265 0.801  
(0.525 to 1.165) (0.542 to 1.183)
 Unknown 4,747 (15.1)  
Diagnosis current  
  restoration placement
 Caries 18,948 (60.2) 6.7 — 1.00 — 1.00  
 Fracture/wear 7,395 (23.5) 10.4 <0.001d 1.489 <0.001d 1.352 –9.24
(1.313 to 1.689) (1.196 to 1.527)
  Other diagnosis 3,424 (10.9) 8.6 0.017d 1.219 0.340 1.081 –11.36
(1.036 to 1.435) (0.921 to 1.268)
 Unknown 1,705 (5.4)  

Descriptive statistics; annual failure rates (after 2 y); adjusted multivariable regression analysis for the practice-, patient-, tooth-, and restoration-
related variables; repeated regressions analysis with the exclusion of individual patient factors; and the percentage difference in HRs.
AFR, annual failure rate; ASA, American Society of Anesthesiologists; DPSI, Dutch Periodontal Screening Index; HR, hazard ratio; SES, socioeconomic
status.
a
Patient factors included.
b
Patient factors excluded.
c
With and without patient-related factors included.
d
P < 0.05.
e
Incalculable.

Practice/Operator-Related Factors susceptible for failure. A high caries risk (HR = 1.572) and the
presence of parafunctional habits (HR = 1.207) resulted in a
Wide variations in AFR2 and HR were found among practitio- higher risk for restoration failure, which further increased for
ners and practices. AFR2 among practitioners ranged from patients having both these risk factors (HR = 1.687). Figure 1
3.6% to 11.7%. The practitioner effect on restoration survival shows the Kaplan-Meier graphs of these 4 risk groups. The
strengthened when individual patients factors were eliminated presence of a partial or full removable denture also strongly
from the regression analysis. compromised restoration survival.
Comparing the HRs from the Cox regression with and with-
out individual patient factors included showed that the effect of
Patient-Related Factors patient age on restoration survival increased when other indi-
Children and adolescents showed the longest restoration sur- vidual patient factors were eliminated from the regression.
vival, while a shorter survival was found for elderly. Table 3 shows that almost 78% of all restorations within the
Restorations placed in medically compromised patients or high caries–risk group were placed due to caries. Moreover,
patients with considerable periodontal disease were more almost 46% of all restorations within the group of patients with
420 Journal of Dental Research 98(4)

Table 3.  Percentages of the Diagnoses of Current Restoration

Placement among the Risk Groups (Caries and Parafunctional Habits).

Diagnosis: Current Restoration

Placement, %

Fracture/
Risk Assessment Caries Wear Other

Low caries risk  

  Without parafunctional habits 51.1 32.5 16.4
  With parafunctional habits 38.8 45.9 15.2
High caries risk  
  Without parafunctional habits 77.8 14.0 8.2
  With parafunctional habits 64.9 26.6 8.5

Bold indicates P < 0.05.

Table 4.  Percentages of the Diagnoses of Current Restoration

Placement in Relation to the Diagnoses of the First Intervention.
Figure 1.  Survival graph of restorations divided by caries risk (CR) and
presence of parafunctional habits (PF). Diagnosis: First Intervention, %

Diagnosis: Current Fracture/ Endodontic

parafunctional habits and a low caries risk profile were placed Restoration Caries Wear Treatment Other
due to fracture or wear (χ2 test, P < 0.001). Caries 20.2 13.8 24.4 11.6
Fracture/wear 18.6 51.2 12.0 18.2
Other 14.1 21.0 36.9 28.0
Tooth/Restoration-Related Factors
Bold indicates P < 0.05.
Restorations showed better survival in premolars than in
molars (HR = 1.383). Most restorations were 2-surface restora-
tions, and the AFR2 and HR increased with an increasing num- In this study, we were capable of extracting extensive data
ber of surfaces. The AFR2 was 7.2% for nonendodontically from the patient files. However, many EPFs were incompletely
treated teeth and 19.2% for endodontically treated teeth (HR = documented and resulted in missing data, which is a limitation
1.890). In the Cox regression, the highly filled composite resin of this study. Traditionally, EPFs in dentistry were mainly used
APX (Kuraray Noritake) showed the lowest AFR2 (5.5%) and for billing purposes and limited to tooth number and surfaces
the lowest risk for failure. Restorations placed with the 3-step as obligatory data. For this study, operators were invited and
etch-and-rinse adhesive Photobond/SA Primer (Kuraray encouraged to complete EPFs with risk assessment, applied
Noritake) performed better than those placed with self-etching materials, and diagnosis of the restoration. As could be
SE Bond (HR = 1.229). Moreover, restorations placed due to expected, dentists did not succeed in collecting all required
fracture were more prone to fail than restorations placed due to data for all patients and treatments. The imputation of missing
caries (HR = 1.489). Table 4 shows that the most frequent diag- data as performed in this analysis was considered the best
nosis for an intervention on a restoration placed due to caries is choice for dealing with this shortcoming. Performing analyses
an endodontic treatment (χ2 test, P < 0.001). Restorations that on complete cases only would likely result in exclusion bias
were placed due to fracture or wear most likely failed due to and loss of power.
fractures or wear again (χ2 test, P < 0.001). Still we have to be careful about interpreting results, as
Comparing HRs from the Cox regression with and without many grounds for bias are included, such as differences among
individual patient factors included showed a divided effect on practitioners in risk assessments, treatment choices, and EPF
tooth- and restoration-related factors. The influence of an end- handling, as well as the operator and evaluator being the same
odontic treatment on restoration survival increased when person. Moreover, this study, with a relatively short observa-
patient characteristics were excluded, while the effect of the tion time, may suffer from “data pollution,” caused by tempo-
diagnoses decreased. rary restorations and specific declaration aspects related to the
reimbursement system in the Netherlands. Especially for
research purposes, calibration and accurateness among opera-
Discussion
tors should be done more extensively, but we chose a gradual
This practice-based cohort study is the first to extensively eval- process of dentists being encouraged and educated to improve
uate the clinical performance of direct restorations related to a their assessments and clinical handling based on the results of
variety of potential risk factors. The results showed that the their own work.
operator, individual patient risk factors (e.g., age, general The main finding of this study is that a plethora of risk fac-
health score, periodontal status, caries risk, and risk for para- tors, especially patient-related variables, is associated with res-
functional habits), tooth-related factors, and the diagnosis of toration failure. Previous studies identified several of these risk
the restoration all influence direct restoration survival. factors, such as SES (Correa et al. 2013), general health,
Risk Factors in Restorative Dentistry 421

periodontal status (Adolphi et al. 2007), oral hygiene (Kopperud et al. 2018) found that the majority of restorative work by these
et al. 2012), high caries risk (Kopperud et al. 2012; van de practitioners was performed on patients with high caries risk. A
Sande et al. 2013), and parafunctional habits (van de Sande et al. much higher AFR can be expected in a nonstudy setting as
2013; Pallesen and van Dijken 2015). Moreover, restoration compared with a controlled trial in a university clinic, where
size (Lucarotti et al. 2014; Laske et al. 2016b) and the presence such high-risk patients are often excluded in data analysis
of an endodontic treatment (Laske et al. 2016b) were found as (Opdam et al. 2018). Signori et al. (2018) also showed that
risk factors for survival. many restorations replaced due to caries indeed had caries
A wide range in operator AFR2 was found, varying between lesions in need of restorative treatment. Some discolored mar-
3.6% and 11.7%, an effect that was confirmed in the Cox gins might be overdiagnosed as caries, but we expect that this
regression. This is remarkable in that all included dentists are number will be limited. Differences among restorative materi-
motivated above average to provide high-quality care. As indi- als were also identified in this study, especially compomer and
cated in our previous retrospective study (Laske et al. 2016b), glass ionomer restorations, which showed shorter survival than
the observed differences may be related to operator skills, clin- that of composite restorations. However, amalgam was hardly
ical experience, sex, and age, but it could also be related to used (n = 57), and compomer and glass ionomer were often
practice organization, intervention choices by the dentists, and used for temporary fillings. Future analysis with an extended
different patient needs and demands. The number of dentists observation time focusing on composite restorations may show
was too low to investigate on dentist-related variables, such as more accurate survival data and would be more appropriate to
age and university. More extensive data collection and further discuss at that moment.
research are needed on these aspects. This study demonstrated that a wide variation of risk factors
An interesting finding is that by leaving out the patient- on the practice, patient, and tooth levels influences the survival
related risk factors, remaining risk factors considerably of class II restorations. To provide personalized oral health
changed in their effect and significance. Many risk factors care, it is important to identify and record potential risk factors
seemed to be interrelated, and their effect changed depending and adjust a treatment to the needs of the patient. Further clini-
on the other risk factors in the analysis. Illustrative is the effect cal studies on dental treatment results should preferably include
of SES, which demonstrated significance between high and these risk factors in data collection and analysis. Especially for
low levels in the absence of patient-related risk factors in the future randomized clinical trials on specific questions (e.g.,
analysis (Table 2), suggesting that the excluded variables are comparison of 2 materials), it seems imperative to include
incorporated in the SES. When patient factors were excluded, these patient variables and deal with the risk factors in a multi-
the effect of the operator increased, suggesting that profiles of variable analysis. As an alternative, patients with specific risk
the patients were different among practitioners such that the factors could be excluded to create a homogeneous patient
dentist effect could be due to some patient-related risks that population, but this might reduce the clinical relevance of the
were unmeasured or not yet identified. These findings rein- study.
force the need to identify, record, and include as many poten-
tial risk factors in the statistical analysis. Author Contributions
In this study, there was a clear relation between the diagno- M. Laske, contributed to conception, design, data acquisition,
sis for restoration failure and the risk group, as shown in Tables analysis, and interpretation, drafted and critically revised the man-
3 and 4. This indicates that the risk assessment as performed by uscript; N.J.M. Opdam, contributed to conception, design, data
the GDP makes sense, and dentists are able to identify these acquisition and interpretation, drafted and critically revised the
risks, although differences among dentists are likely to occur. manuscript; E.M. Bronkhorst, contributed to design, data analysis
The further-increased failure rate when both parafunctional and interpretation, drafted and critically revised the manuscript;
habits and caries were present was also demonstrated by van de J.C.C. Braspenning, contributed to design and data interpretation,
Sande et al. (2013). However, deep caries lesions, when drafted and critically revised the manuscript; M.C.D.N.J.M.
restored, may result in early failure due to pulpitis complaints Huysmans, contributed to conception, design, and data interpreta-
resulting in an endodontic treatment, which is a well-known tion, drafted and critically revised the manuscript. All authors
early failure in restorative dentistry (Opdam et al. 2014). gave final approval and agree to be accountable for all aspects of
Therefore, the considerably high amount of endodontic fail- the work.
ures related to caries seems logical and related to the short
observation time of the present study. Acknowledgment
Generally, this study showed a considerably higher failure We acknowledge the general dental practices for putting their data
rate than that found in many controlled clinical studies. at our disposal and for participating in the practice network meet-
Although we should take into consideration that the pressure of ings. We and the general dental practitioners thank Kuraray Europe
routine general dentistry could have reduced the quality of Benelux for providing Majesty ES-2, SE Bond, and SE Protect. We
placed restorations, a likely factor that explains the higher fail- also thank Exquise for making it possible to extract the data digi-
ure rate is that 65.4% of the patients assessed on risk factors tally from the electronic patient files. The authors received no
were scored as high risk for caries and/or parafunctional habits. financial support and declare no potential conflicts of interest with
Another study based on the same patient population (Signori respect to the authorship and/or publication of this article.
422 Journal of Dental Research 98(4)

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