Prosthetic dentistry
GLASS-IONOMER AND RESIN COMPOSITE RESTORATIONS IN
PRIMARY MOLARS: A 36-MONTH PROSPECTIVE CLINICAL STUDY
Florentina RADU1, Albertine LEON2, Cristian Lucian PETCU3, Rodica LUCA4
1
PhD Student, DMD, ”Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2
Assistant Professor, DMD, PhD, ”Ovidius” University, Constanţa, Romania
3
Associate Professor, PhD, ”Ovidius” University, Constanţa, Romania
4
Professor, DMD, PhD, ”Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
Corresponding author: Albertine Leon; e-mail: dr_aleon@yahoo.com
Abstract
Introduction. The clinical performance of Equia Fil
glass-ionomer cement (GIC) and Essentia composite resin
(CR) in restoring primary molars affected by caries was
assessed. Materials and methods. 120 GIC and 77 CR
restorations were applied and followed-up for 36 months,
being assessed for the appearance of secondary caries and
retention loss. Overall annual failure rate (AFR) was
calculated. Chi-squared statistical test for the comparison
of two proportions and Kaplan-Meier survival analysis
were performed (the significance level being set at p<0.05).
Result and discussions. The success rate of CR after the
36-month evaluation was 84.42% regarding secondary
caries and 90.91% regarding retention; GIC success rates
were 60%. CR AFR was 5.19% for secondary caries and
3.03% for retention; GIC AFRs were 13.33%. Statistically
significant differences were found between the two
survival curves, GIC having a higher estimated relative
risk for secondary caries and retention loss than CR.
Conclusion. CR restorations performed better clinically
than GIC concerning secondary caries and retention.
Keywords: primary molars, glass-ionomer cement,
composite resin, success rate, Kaplan-Meier survival curves.
1. INTRODUCTION
Dental caries is the most common dental
condition which can sometimes start at a very
young age. Modern dental caries management
should be as conservative as possible and include
early detection of dental caries in the incipient
lesion stage, identifying the individual risk of
cavity progression and active supervision in order
to apply appropriate preventive measures,
supplemented, when indicated, with restorative
therapy [1]. In case of already formed cavity
lesions, it is important to choose the most suitable
restoration material for each clinical condition. In
International Journal of Medical Dentistry
case of primary dentition, choosing the best
treatment method is decisive for tooth maintenance
as close as possible to physiological exfoliation.
Molars are the most frequently caries-affected
primary teeth. Treating primary molars affected
by caries is of utmost importance in order to
prevent multiple complications. Primary molar
crown destruction can be prevented by the use of
plastic restorative materials or preformed metal
crowns. For a long time, silver amalgam was the
most widely-used material. Yet, the controversy
concerning the safety of the dental amalgam,
together with an increasing demand for esthetic
alternatives have reduced its utility [2]. As
alternatives, composite resins (CR), conventional
glass-ionomer cements (GIC), metal-modified
glass-ionomer cements (MMGIC), resin-modified
glass-ionomer cements (RMGIC) and polyacid-
modified resins (compomers), may be used [2-4].
Assessment of clinical performances of
restorations performed with such materials in
primary molars revealed a great variability of the
success rates and that clinical success depends
on a number of factors related to the restoration
material, physician and patient. The main failures
identified were due to secondary caries and
fracture/loss of restorations. Many of the failures
occurred within two years of restoration
placement [5].
Since in Romania, according to our knowledge,
there were no studies published on the evaluation
of restorations in primary teeth, the aim of our
study was to evaluate the clinical performance
of conventional restoration materials (GIC, CR)
in restoring primary molars affected by caries.
127
Florentina RADU, Albertine LEON, Cristian Lucian PETCU, Rodica LUCA
2. MATERIALS AND METHODS
Design
A prospective study was conducted in a
private pediatric dental office in Constanta,
Romania. All children seeking treatment of
dental caries in primary molars during 2014-
2015, aged between 24-96 months, were treated.
Inclusion criteria
Primary molars with caries on one or more
surfaces but with sufficient hard tissue for
retention of restoration;
- Teeth at least three years distance from
exfoliation;
- Cooperative and pre-cooperative children,
mentally and physically healthy, whose
parents or legal guardians gave written
informed consent for study participation;
- Patients who were able to attend dental visits
at specific follow-up intervals.
Restorative procedure
All treatment stages were performed and
registered in patient dental records by a single
operator, who is a pediatric dentist.
Cavity preparation was made with low-speed
drills and dentine excavators; enamel margins
were finished with high-speed diamond burs.
No general anaesthesia/sedation or local
anaesthesia was used. In molars with pulpal
pathology, adequate pulp treatment was
previously performed. Conventional restorations
were placed under relative isolation with cotton
rolls and saliva ejector.
Restoration materials, a high viscosity glass-
ionomer (HVGIC) (Equia Fil capsules, GC
Europe, A2 shade) and a composite (Essentia
light-cured restorative, GC Europe, LD shade)
were handled according to the manufacturer’s
recommendations. Deep cavities were lined with
calcium hydroxide (Ultracal, Ultradent, USA)
and a GIC base (Fuji IX, GC Europe) was applied
prior to composite resin. Composite restorations
were placed using the etch-and-rinse adhesive
system: enamel and dentine were etched with
37% phosphoric acid gel and covered with
G-Premio Bond adhesive, GC Europe.
Restorations were finished and polished with
128
fine-grained diamond burs, sandpaper strips
and silicone tips with aluminium oxide paste.
Criteria for restoration assessment
Each restoration was clinically evaluated in
terms of maintenance (retention) and the
appearance of secondary caries at 6, 12, 18, 24
and 36 months after placement by the same
operator who performed the treatment. A
modification of the USPHS Ryge criteria by
Barnes et al [6] was used for restoration
assessment.
The scores assigned for secondary caries assessment
were:
A: clinically undetected caries;
B: clinically present caries.
For retention/loss of restoration the following scores
were assigned:
A: restoration intact and fully retained;
B: restoration partially retained;
C: restoration completely missing.
Score A was considered success and scores B
and C, failures. No fluoridation was performed
at periodical dental visits.
Statistical analysis
Data collected from patient records were
transferred to a database and analysed with IBM
SPSS Statistics 20 software. Chi-squared test for the
comparison of two proportions was used to assess
GIC and CR restorations concerning the
appearance of secondary caries and retention loss.
Kaplan-Meier analysis was used to draw
survival curves for the two restoration materials,
the event of interest consisting in the appearance
of secondary caries and retention loss. The log-
rank test was used to compare survival curves.
Hazard ratios (HR) and their 95% confidence
intervals were estimated. For all statistical
analyses, the significance level was set at 5%.
Overall annual failure rate (overall AFR) was
calculated as: total number of failures in the
research divided by the total number of
restorations placed divided by the number of
years of observation, and expressed as percentage
[7]. Failure rates for each evaluation period (FR)
were calculated as: number of new failures
registered at each evaluation period divided by
the number of restorations remaining in the
study, and expressed as percentage.
Volume 23 • Issue 1 January / March 2019 •
 GLASS-IONOMER AND RESIN COMPOSITE RESTORATIONS IN PRIMARY MOLARS: A 36-MONTH PROSPECTIVE
CLINICAL STUDY

3. RESULTS months) and 77 CR (in 35 patients, mean age

54.72 months). Table 1 shows the distribution of
A total of 197 conventional restorations were restorations according to: location, type (occlusal;
applied in the 84 children needing crown approximal – mesio-occlusal and disto-occlusal;
restoration due to uncomplicated and complicated extensive), pulp status and children’s age at the
caries: 120 GIC (in 49 patients, mean age 56.56 moment of placement.
Table 1. Distribution of restorations

Molars Restorations
First Second GIC CR
n % n % n % n %
111 100 86 100 120 100 77 100
Upper 53 47.7 35 40.7 48 40 40 51.9
Arch
Lower 58 52.3 51 59.3 72 60 37 48.1
Class I 64 57.7 47 54.7 62 51.7 49 63.6
Cavity Class II 43 38.7 37 43 53 44.2 27 35.1
Extensive 4 3.6 2 2.3 5 4.2 1 1.3
Vital 95 85.6 69 80.2 91 75.8 73 94.8
Pulp status
Non-vital 16 14.4 17 19.8 29 24.2 4 5.2

Childrens’ age 24-59 69 62.2 54 62.8 72 60 51 66.2

(months) 60-96 42 37.8 32 37.2 48 40 26 33.8

Tables 2 and 3 display the comparative results the appearance of secondary caries and retention
of GIC and CR restorations evaluation, concerning loss, in all follow-up periods.

Table 2. Comparative analysis of GIC and CR restorations: secondary caries

(Comparison of two proportions test)

GIC CR
Evaluation
period Total Successful Total Successful p value
(months) %p1 %p2
(n) (n) (n) (n)
Secondary caries

6 116 96.67 77 100.00 0.106

12 109 90.83 77 100.00 0.006 *
18 101 84.17 76 98.70 0.001 *
77
24 120 88 73.33 72 93.51 0.000 *
36 72 60.00 65 84.42 0.000 *
* Statistically significant: p < 0.05

International Journal of Medical Dentistry 129

Florentina RADU, Albertine LEON, Cristian Lucian PETCU, Rodica LUCA

Table 3. Comparative analysis of GIC and CR restorations: retention

(Comparison of two proportions test)

Evaluation GIC CR
period Total Successful Total Successful p value
% p1 % p2
(months) (n) (n) (n) (n)
Retention

6 116 96.67 77 100.00 0.106

12 111 92.50 77 100.00 0.014 *
18 107 89.17 77 100.00 0.003 *
120 77
24 88 73.33 76 98.70 0.000 *
36 72 60.00 70 90.91 0.000 *
* Statistically significant: p < 0.05

The final assessment of restorations, performed caries (Fig. 1a), statistically significant differences
after 36 months of follow-up, showed a 84.42% were found between the two survival curves:
success rate for CR and 60% for GIC, as regards to Chi-square = 14.13, df = 1, p = 0.0002 < 0.05
secondary caries; success rates concerning (Logrank test). The estimated relative risk of
retention were 90.91% for CR and 60% for GIC. secondary caries in GIC restorations was 3.00
There were no statistically significant differences times higher than in CR (Hazard ratios with 95%
between GIC and CR restorations concerning confidence interval).
retention and secondary caries after 6 months of As regards to restoration retention (Fig. 1b),
follow-up. Statistically significant differences were statistically significant differences were found
found at subsequent controls, CR restorations between GIC and CR: Chi-square = 23.04, df = 1,
showing higher success rates (Tables 2 and 3). p < 0.0001 < 0.05 (Logrank test). The estimated
Kaplan-Meier survival curves for GIC and relative risk of retention loss in GIC restorations
CR restorations were drawn for the entire period was 5.21 times higher than in CR (Hazard ratios
of clinical evaluation. While assessing secondary with 95% confidence interval).

a) __ GIC; __ CR b)

Fig. 1. Kaplan-Meier survival curves for GIC and CR restorations: a) secondary caries; b) retention

130 Volume 23 • Issue 1 January / March 2019 •

 GLASS-IONOMER AND RESIN COMPOSITE RESTORATIONS IN PRIMARY MOLARS: A 36-MONTH PROSPECTIVE
CLINICAL STUDY

The overall annual failure rate (Overall AFR) 5.19% and 3.03% respectively. The new
in GIC restorations was 13.33% due to the restoration failures (FR), which appeared from
appearance of both secondary caries and retention one observation period to another, are shown in
loss; in CR restorations the overall AFR was Figures 2 and 3.

120 120 116

109
101
88
77 77 77 77 76 72
48

13 16 12 Examined
4 7 8 4 7
0 0 1
Failed
Final 6 mos. 12 mos. 18 mos. 24 mos. 36 mos. Final 6 mos. 12 mos. 18 mos. 24 mos. 36 mos.
results results

Overall FR: FR: FR: FR: FR: Overall FR: 0% FR: 0% FR: FR: FR:
AFR: 3.33% 6.03% 7.34% 12.87% 18.18% AFR: 1.30% 5.26% 9.72%
13.33% 5.19%

SECONDARY CARIES

GIC CR

Fig. 2. GIC and CR restorations failure rates (AFR and FR), due to secondary caries

120 120 116

111 107
88
77 77 77 77 77 76

48

19 16 Examined
4 5 4 7 6
0 0 0 1 Failed
Final 6 mos. 12 mos. 18 mos. 24 mos. 36 mos. Final 6 mos. 12 mos. 18 mos. 24 mos. 36 mos.
results results

Overall FR: FR: FR: FR: FR: Overall FR: 0% FR: 0% FR: 0% FR: FR:
AFR: 3.33% 4.31% 3.60% 17.76% 18.18% AFR: 1.29% 7.89%
13.33% 3.03%

RETENTION

GIC CR

Fig. 3. GIC and CR restorations failure rates (AFR and FR), due to retention loss

4. DISCUSSION use of anaesthesia and rubber dam; periodical

Conventional restoration of primary molars
affected by caries is a frequent procedure in the
dental practice [8]. Restoration survival depends
on multiple factors that are difficult to account
for. Some of them are treatment-related (such as
operator’s skill; material choice and handling;
fluoridation; tooth type and position in the dental
arch; number of restorations; cavity type; size of
lesion) and other are patient-related (age; socio-
economic status; carious risk; bruxism; type of
food consumed; dental hygiene) [9-11].
The success rates reported in the literature
vary depending on a number of parameters,

International Journal of Medical Dentistry 131

Florentina RADU, Albertine LEON, Cristian Lucian PETCU, Rodica LUCA
including the type of preparation/cavity and the
type of restoration material used. Thus, Hickel et
al. [5], following the analysis of the results of
some studies published during 1971-2003, which
evaluated class I and II restorations made with
different commercial types of materials, reported
success rates between 40-98.9% for CR and 9.5-
98% for GIC (to note that none was HVGIC). AFR
values were between 0.6-15% for CR and 1.8-
25.8% for GIC [5]. Dos Santos Pinto et al. [12]
reported 9.5% AFR for CR restorations and 12.9%
for GIC.
The present study showed a 84.42% success
rate for CR restorations assessed for secondary
caries and a 90.91% success rate concerning
retention, after 36 months from restoration
placement. Overall AFR was 5.19% due to
secondary caries and 3.03% due to partial/total
retention loss. Success rates of GIC restorations
were 60% and overall AFR were 13.33% (both for
secondary caries and retention). By comparing
our results with those above, the success rate for
CR is close to the highest reported values ​​and
AFR is among the average values. Concerning
the HVGIC used by us, Equia Fil, the success rate
obtained is closer to that reported by Resmiye et
al [11] (54.2%), at the 18-month evaluation of
secondary caries and retention in class II cavities
in primary teeth.
In the present study, CR restorations evidenced
better clinical behaviour than GIC in terms of
retention and appearance of secondary caries.
GIC restorations displayed a 3.00 times higher
estimated relative risk of appearance of secondary
caries and a 5.21 times higher risk of losing
retention than CR restorations. In fact, in a meta-
analysis study, GIC is emphasized to demonstrate
a higher risk of failure than other conventional
restoration materials [13].
Regarding the protection offered by GIC, in
our study we might have expected the application
of GIC to inhibit the onset of secondary caries
more. A possible explanation of our results might
be given by Randall and Wilson [14], who argued
that the release of fluoride or other ions and
bacteriostatic effects may vary widely depending
on the different types of GIC. Likewise, the
amount of fluoride needed to prevent
demineralization of enamel and dentin is not
132
exactly known and it is believed that it might not
be the same for both structures [14,15].
The clinical performance of conventional
restorations is influenced by various factors with
cumulative actions, acting in the oral environment.
Best treatment outcomes are obtained by taking
into account as many as feasible. Considering
that in the present study most restorations were
applied to younger children (24-59 months age
group), without making use of general/local
anaesthesia or rubber dam isolation, the results
obtained are satisfactory.
5. CONCLUSIONS
The results of the study showed that composite
resins used to restore primary molars affected by
caries performed better clinically than glass-
ionomer cement [HVGIC] in the assessment of
secondary caries and retention subsequent to a
period of 36 months.
Conflict of interest. The authors declare no
conflict of interest.
References
1. American Academy of Pediatric Dentistry.
Recommendations: Best Practices. Caries-risk
Assessment and Management for Infants, Children,
and Adolescents [Internet]. Reference Manual, 40(6),
2018/19: 205-12 [cited 2019 January 30]. Available
from: http://www.aapd.org/media/Policies_
Guidelines/BP_CariesRiskAssessment.pdf
2. American Academy of Pediatric Dentistry.
Recommendations: Best Practices. Pediatric
Restorative Dentistry [Internet]. Reference Manual,
40(6), 2018/19: 330-42 [cited 2019 January 30].
Available from: http://www.aapd.org/media/
Policies_Guidelines/BP_RestorativeDent.pdf
3. Donly KJ, García-Godoy F. The use of resin-based
composite in children. Pediatr Dent. 2015;37(2):136-43.
4. Sidhu SK. Glass-ionomer cement restorative
materials: a sticky subject? Aust Dent J. 2011;56
Suppl 1:23-30.
5. Hickel R, Kaaden C, Paschos E, Buerkle V, García-
Godoy F, Manhart J. Longevity of occlusally-stressed
restorations in posterior primary teeth. Am J Dent
2005;18(3):198-211.
6. Barnes DM, Blank LW, Gingell JC and Gilner PP. A
clinical evaluation of a resin-modified glass ionomer
restorative material. J Am Dent Assoc.
1995;126(9):1245-53.
Volume 23 • Issue 1 January / March 2019 •
 GLASS-IONOMER AND RESIN COMPOSITE RESTORATIONS IN PRIMARY MOLARS: A 36-MONTH PROSPECTIVE
7. Bucher K, Metz I, Pitchika V, Hickel R, Kuhnisch J.
Survival characteristics of composite restorations in
primary teeth. Clin Oral Invest. 2015;19(7):1653-62.
8. Chisini LA, Collares K, Cademartori MG, de Oliveira
LJC, Conde MCM, Demarco FF, Correa MB.
Restorations in primary teeth: a systematic review
on survival and reasons for failures. Int J Paediatr
Dent. 2018;28(2):123-39.
9. Tseveenjav B, Furuholm J, Mulic A, Valen H, Maisala
T, Turunen S, Varsio S, Auero M, Tjaderhane L.
Survival of extensive restorations in primary molars:
15-year practice-based study. Int J Paediatr Dent.
2018;28(2):249-56.
10. Opdam NJM, Collares K, Hickel R, Bayne SC,
Loomans BA, Cenci MS, Lynch CD, Correa MB,
Demarco F, Schwendicke F, Wilson NHF. Clinical
studies in restorative dentistry: New directions and
new demands. Dent Mater. 2018;34(1):1-12.
11. Resmiye ET, Sevi B C, Ersin O. Retrospective clinical
evaluation of a polyacid-modified resin composite
and two glass ionomer cements in class ii cavities of
primary teeth: eighteen-month results. Adv Dent &
International Journal of Medical Dentistry
CLINICAL STUDY
Oral Health. 2017;3(4):555616. DOI:10.19080/
ADOH.2016.03.555616.
12. Dos Santos Pinto G, Oliveira LJC, Romano AR,
Schardosim LR, Bonow MLM, Pacce M, Correa MB,
Demarco FF, Torriani DD. Longevity of posterior
restorations in primary teeth: Results from a
paediatric dental clinic. J Dent. 2014;42(10):1248-54.
13. Pires CW, Pedrotti D, Lenzi TL, Soares FZM,
Ziegelmann PK, Rocha RO. Is there a best
conventional material for restoring posterior
primary teeth? A network meta-analysis. Braz Oral
Res. 2018;32:e10. doi: 10.1590/1807-3107bor-2018.
vol32.0010.
14. Randall RC, Wilson NHF. Glass-ionomer Restoratives:
A Systematic Review of a Secondary Caries Treatment
Effect. J Dent Res. 1999;78(2):628-37.
15. Vasiliu MP, Sachelarie L, Romila LE, Shardi A,
Stadoleanu C. Rheological properties of some
materials used for dental impression. Journal of
Biomimetics, Biomaterials and Biomedical
Engineering. 2017;34:75-81.
133