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Partial Removal of Carious Dentine: A Multicenter Randomized Controlled
Trial and 18-Month Follow-Up Results
Article in Caries Research · November 2012
DOI: 10.1159/000344013 · Source: PubMed
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Original Paper
Caries Res 2013;47:103–109
DOI: 10.1159/000344013
Received: November 1, 2011
Accepted after revision: September 14, 2012
Published online: November 28, 2012
Partial Removal of Carious Dentine:
A Multicenter Randomized Controlled
Trial and 18-Month Follow-Up Results
M. Maltz a J.J. Jardim a H.D. Mestrinho b P.M. Yamaguti b K. Podestá a
M.S. Moura a L.M. de Paula b
Federal University of Rio Grande do Sul, Porto Alegre, and b Brasilia University, Brasilia, Brazil
Key Words
Caries removal Clinical trial Dentine caries Permanent
teeth Restorations Restorative materials
Abstract
Aim: The aim of this study was to evaluate the effectiveness
of partial removal of carious dentine and restoration in a single session (PDR) and stepwise excavation (SW), both of
which are treatments for deep carious lesions, in Public
Health Services in Brazil. Methods: Inclusion criteria: patients
66 years old, permanent molars with deep caries lesions
(having a radiolucency halfway or more into dentine) and
pulp vitality but absence of spontaneous pain, positive percussion test, and periapical alterations. The subjects received
either PDR (test group) or SW (control group). The radiological and clinical exams were performed after a mean time of
18 months. Outcomes: success was defined as pulp sensitivity to cold test and absence of periapical alterations. Results:
Of the 299 treatments performed, 146 were SW and 153 were
PDR; 122 were amalgam restorations and 168 resin-composite restorations. There were no differences between the
groups regarding the baseline characteristics (i.e. age, gender and family income). After 18 months, 212 evaluations
© 2012 S. Karger AG, Basel
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were performed, which indicated 99 and 86% success rates
in the PDR and SW groups, respectively (p = 0.016). Reasons
for failure were: PDR – 1 pulpitis; SW – 8 pulpitis; 1 osteitis; 4
necrosis; 1 endodontic treatment. None of the baseline variables were significantly associated with the outcomes. Conclusion: The retention of carious dentine does not interfere
in pulp vitality. Data from this 18-month study suggest that
the procedure of reopening the cavity to remove the residual infected dentine is not necessary.
Copyright © 2012 S. Karger AG, Basel
The management of deep caries lesions has been discussed extensively in the literature [Magnusson and Sundell, 1977; Leksell et al., 1996; Bjørndal et al., 1997;
Bjørndal and Thylstrup, 1998; Weerheijm et al., 1999;
Maltz et al., 2002; Massara et al., 2002; Paddick et al.,
2005; Pinto et al., 2006; Ricketts et al., 2006]. These papers cover different topics, including the appropriate instruments for removing carious tissues, the amount of
decayed tissue that needs to be removed [Bjørndal and
Thylstrup, 1998], and the interaction between pulp and
dentine [Massara et al., 2002; McLachlan et al., 2003; Lee
et al., 2006].
Marisa Maltz
Faculdade de Odontologia – UFRGS, Departamento de Odontologia Preventiva e Social
Ramiro Barcelos, 2492, Bom Fim
CEP 90035-003 Porto Alegre (Brazil)
E-Mail marisa.maltz @ gmail.com
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a
104
.
Caries Res 2013;47:103–109
[Falster et al., 2002; Maltz et al., 2002; Marchi et al., 2006;
Oliveira et al., 2006; Maltz et al., 2007; Alves et al., 2010].
The results of the above-mentioned series of publications
show that the partial removal of caries dentine in deep
lesions is a promising alternative for preserving pulp vitality. In a single-arm observational trial, patients with
deep caries lesions in the permanent posterior teeth underwent partial removal of the carious dentine and resin
restoration in a single session [Maltz et al., 2002]; after 10
years of follow-up, the overall success rate was 62%. The
radiographs showed an increase in the radiopacity of the
carious dentine remaining at the bottom of the cavity,
indicating a possible mineral gain during that time [Alves
et al., 2010]. The number of microorganisms was also reduced after sealing the cavity, reaching the levels usually
encountered in cavities in which all carious tissue is removed according to the hardness criteria [Maltz et al.,
2002; Orhan et al., 2008; Lula et al., 2009]. In deciduous
teeth, after indirect pulp capping, the increase in dentine
hardness observed clinically could also be confirmed in
vitro with a microhardness test [Marchi et al., 2008; Franzon et al., 2009].
Ricketts et al. [2006] performed a systematic review of
the literature regarding the conservative management of
carious lesions and found that SW exhibited clinical success. However, no controlled clinical trial analyzing the
sealing of carious tissue in deep carious lesions has been
performed in permanent teeth. Considering all this information, there is still at least one question that needs to
be answered: is there a need to reopen the cavity after
partial excavation? The aim of the present multicenter
randomized controlled clinical trial was to evaluate the
effectiveness of partial removal of carious dentine and
restoration in a single session (PDR) compared with SW
for treating deep carious lesions in Public Health Service
Dental Practices in Brazil.
Materials and Methods
Ethics
The study was approved by the Federal University of Rio
Grande do Sul Ethics Committee (protocol 18/05), the Porto
Alegre Municipal Ethics Committee (protocol 27/06 and registration No. 001000837067), the Conceição Hospital Ethics Committee (protocol 070/05), and the Brasilia University Hospital Ethics
Committee (protocol 045/2005). All participants provided written informed consent. All dental needs required by the subjects
enrolled in this research were provided, except prosthetic rehabilitation and orthodontic treatment, during the whole study period.
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In order to preserve dental structures as much as possible and avoid irreversible damage to the pulp, some conservative techniques concerning carious dentine removal
have been proposed [Magnusson and Sundell, 1977;
Bjørndal et al., 1997; Bjørndal and Thylstrup, 1998; Maltz
et al., 2002; Pinto et al., 2006]. Among them is the stepwise excavation technique (SW), which involves the partial removal of the decayed tissue leaving some caries at
the bottom of the cavity, temporary sealing for 1–6
months, subsequently reopening the cavity, and fully removing the carious tissue followed by restoration [Magnusson and Sundell, 1977; Bjørndal et al., 1997; Bjørndal
and Thylstrup, 1998]. During the temporary sealing, the
remaining carious dentine becomes harder and drier,
both characteristics of inactive lesions, and exhibit a low
level of bacterial infection [Bjørndal et al., 1997]. The aim
of this procedure is to allow the occurrence of physiological reactions in the pulp-dentine complex, including
dentine sclerosis and tertiary dentine formation [King et
al., 1965; Massler, 1978]; this ensures the protection of
pulp tissue during the reentry by avoiding pulp exposure.
Many studies have shown that this treatment can achieve
a high level of success [Magnusson and Sundell, 1977;
Leksell et al., 1996; Bjørndal and Thylstrup, 1998]. A recent study using SW in the permanent dentition has reported a success rate of 74.1% after 1 year of follow-up
[Bjørndal et al., 2010]. The disadvantages of SW are mainly the risk of pulp exposure during the reentering of the
cavity [Magnusson and Sundell, 1977; Leksell et al., 1996;
Bjørndal and Thylstrup, 1998; Bjørndal et al., 2010], failure of the temporary filling, and increased cost (2 sessions are needed to complete the treatment). In addition,
some patients may never return for the second appointment once their pain problem has been solved.
Furthermore, if all decayed tissue is removed in a deep
carious lesion and the pulp is exposed, a very common
treatment used is direct pulp capping. A retrospective
study evaluated the treatment outcomes of pulp-capped
teeth after 5 and 10 years and showed that 79.7% of the
teeth exhibited necrosis and required postoperative root
canal treatment or an extraction after 10 years [Barthel et
al., 2000]. Bjørndal et al. [2010] evaluated direct pulp capping performed on permanent teeth with deep carious
lesions and reported a success rate of only 31.8% after
1 year of treatment. Similar results were obtained if the
teeth were treated with partial pulpotomy (34.5% success
rate).
In order to avoid these problems, it is proposed that the
definitive restoration should be placed during the same
session in which the partial caries removal is performed
Maltz /Jardim /Mestrinho /Yamaguti /
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.
.
Selection
Clinical and radiographic exams
Selection and invitation to join the study
(n = 299)
Analysis
Outcome Follow-up
Randomization
Excluded
There was no exclusion after
clinical and radiographic
selection
Randomized
(n = 299)
Test (PDR)
(n = 153)
Control (SW)
(n = 146)
Lost to follow-up 18 months
(n = 41)
Lost to follow-up 18 months
(n = 45)
Outcome
Pulp sensitivity
Outcome
Pulp sensitivity
Analyzed PDR
(n = 112)
Analyzed SW
(n = 101)
Fig. 1. Study design.
Sample
The sample size calculation was based on a difference in the
percentage of success of SW and partial removal of caries after
a 5-year follow-up period of 60.9% [Parolo et al., 2007] versus
82% [Maltz et al., 2007] at = 5% with a power of 90%. This in-
Partial Removal of Carious Dentine:
18-Month Follow-Up Results
dicated the need for 76 restorations per treatment group. Taking
into account a dropout rate of 56% after 2 years [Busnello et al.,
2001], the maximum number of restorations required was 119 per
group.
Subjects were recruited in 2 ways: from the examination of
patients receiving services and by actively searching for individuals potentially fulfilling the inclusion criteria; the active search
was carried out by the researchers in community programs, local
schools, and through newspaper and radio advertisements.
Inclusion Criteria
• Patients who were at least 6 years of age at the time of treatment
• Permanent molars exhibiting primary deep caries lesion
where the judgment of the clinicians was that complete caries
removal would lead to pulp exposure
• A carious lesion involving half or more of the dentine detected
by radiographic examination
• Positive response to the cold test (–20 ° C refrigerated gas; Aerojet, Rio de Janeiro, Brazil)
• Absence of spontaneous pain
• Negative sensitivity to percussion
• Absence of periapical lesions assessed by radiographic examination
Exclusion Criteria
• Subjects with general diseases affecting their caries experience
• Cusp loss
Caries Res 2013;47:103–109
105
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Study Design
This is a multicenter randomized controlled clinical trial (registration No. NCT00887952. www.clinicaltrials.gov). Details of
the study design can be seen in figure 1.
The clinical treatments were carried out by 22 dentists and
supervised by the main researchers (M.M., L.M.P., H.D.M., and
J.J.J.) over 2 years. The centers involved were located in Brasilia
(Federal District, FD) in the eastern-central part of Brazil and
Porto Alegre (Rio Grande do Sul, RS) in the south. The RS center
was mainly responsible for the research. In the FD center, both
sample selection and treatments were performed by 10 dentists
from the Brasilia University Hospital. In the RS center, the sample
selection and treatments were performed by 5 dentists from the
Federal Health Service, 4 dentists from the Municipal Health Service, and 3 dentists (2 postgraduate students and 1 clinician) from
the Federal University of Rio Grande do Sul. All dentists were updated and trained before the beginning of the clinical procedures
by 2 main researchers (M.M. and L.M.P.).
The materials used to perform the treatments as well as the
clinical files were supplied by the RS center to all treatment centers, ensuring standardization.
Randomization and Blinding Procedures
The choice between test and control was done by raffle: the
treatment group was indicated on a piece of paper, numbered, and
kept in a dark flask; a person other than the dentist executing the
treatment selected a piece of paper from the dark flask at the appropriate moment (see Clinical Procedures); the selected piece of
paper was not returned to the flask. The filling material was determined on a weekly basis, alternating between amalgam and
resin in each treatment center.
Blinding of the participants was not possible because the treatments required different numbers of appointments. However, the
operators were blinded to the caries removal procedure (see ‘Clinical Procedures’).
Clinical Procedures
All procedures were carried out under local anesthesia and
rubber dam. The treatments were performed as follows:
• Access to the lesion by using rotary instruments (if necessary)
• Complete removal of carious tissue from the cavity walls (according to hardness criteria) by using low-speed metal burs
and/or hand excavator
• Partial removal of the soft carious tissue from the cavity floor
by hand excavator (only disorganized dentine was removed)
[Bjørndal and Thylstrup, 1998]
• Cleaning with distilled water and drying with sterile filter paper
• Group randomization: the randomization was performed after caries removal to avoid the possible influence of the amount
of carious dentine removed
If the tooth was assigned to the PDR group, the following procedure was performed:
• The cavity was partially filled with glass ionomer cement (Vitro Fil; DFL, Rio de Janeiro, Brazil)
• Restoration using amalgam (SDI, Bayswater, Australia) or resin composite (Tetric EvoCeram + Excite + Total Etch; Ivoclar
Vivadent, Liechtenstein) was performed using the incremental
technique and following the instructions of the manufacturer
If the tooth was assigned to the SW group, the following procedure was performed:
• Lining with calcium hydroxide cement (Dycal; Caulk/Dentsply, Rio de Janeiro, Brazil)
• Temporary filling with a modified zinc oxide-eugenol cement
(IRM; Caulk/Dentsply, Rio de Janeiro, Brazil)
• Cavity reopening after a median time of 90 days (25th percentile = 60 days; 75th percentile = 150 days; mean 120 8 120
days) and removal of the remaining soft carious tissue
• Restoration following the same procedures as described for
the PDR group
The time (in minutes) taken to perform each treatment was
recorded.
Clinical and Radiographic Evaluations
Outcomes: success was defined as pulp sensitivity to cold test
and absence of periapical alterations (combined outcome); these
106
Caries Res 2013;47:103–109
parameters were assumed to be indicators of pulp vitality. The
treatment evaluation was performed after a mean time of 18
months (range 1–18 months).
The radiological observations were performed during screening (periapical and bitewing radiography), right after the treatment (bitewing radiography), and then during control visits (periapical radiography).
Clinical evaluation of the restorations was carried out by
trained dentists right after the treatment and then annually. The
results from these evaluations will be published separately.
As this study was evaluated as an intention-to-treat analysis,
protocol deviations were also included in the study sample. Cases
of restoration failure, secondary caries, or incomplete SW (patient
did not return for the second appointment) were treated and analyzed within the arm to which they had been randomized.
As baseline characteristics, the following items were recorded:
age of subject (years), gender and family income (in local currency). Regarding the treatment, the following variables were analyzed: filling material, surfaces involved in the filling, time spent
to complete the restoration, and size of the cavity (11/3 the width
of the crown in the buccolingual orientation; !1/3 the width of
the crown in the buccolingual orientation). All data were recorded in the clinical files and online with a digital system specially
developed for the study. http://odonto.cityzoom.net.
Statistics
The 2 test was used to compare the success rates of the 2 experimental procedures. The correlations between the recorded
variables and outcomes were analyzed by logistic regression. Possible differences between followed and nonfollowed cases were
also analyzed by logistic regression. The significance level was set
at 5%, and the unit of analysis was the restoration.
All analyses were performed using the Statistical Package for
Social Science (SPSS) software, version 13.0.
Results
Of the 299 treatments performed, 146 were SW and
153 were PDR; 122 were amalgam restorations and 168
resin-composite restorations. From the 233 patients included in the study, 78% received 1 treatment, 18% received 2 treatments and 4% received 3 or more treatments. The participants were mainly adolescents; mean
age was 17.17 (median 14 years; minimum 6 and maximum 53 years), with a standard deviation of 10.91 years.
The majority of the subjects were studying in public
schools (72%). The mean DMFT was 7.9 8 5.7. Regarding
the socioeconomic status, most participants came from
low-income families [Brazilian Institute of Geography
and Statistics (IBGE), http://www.ibge.gov.br/home/].
There were no significant differences between the groups
with respect to the baseline characteristics such as age,
gender or family income (table 1).
Maltz /Jardim /Mestrinho /Yamaguti /
Podestá /Moura /de Paula
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Study Groups
The subjects were randomly assigned to test or control groups,
which received PDR or SW, respectively. Each of these groups was
further divided according to the filling material: amalgam or resin composite.
Table 1. Baseline characteristics of subjects according to treat-
Table 4. Time taken to perform the treatments according to
ments
groups and filling material
Group/ Subjects Age, years Male Female Family income,
variable
BRL
Treatments
Time, min
SW (n = 146)
PDR (n = 153)
78.3821.3
47.8815.4
146
16.687.5
56
90
PDR
153
16.387.2
54
99
600.00
(380.00, 800.00)
600.00
(380.00, 960.00)
Age is expressed as means 8 SD. Family income is expressed
as median with quartiles 25 and 75 in parentheses (BRL 1 = USD
1.75). There were no differences between the groups at baseline
(p > 0.05).
Table 2. Success rates (outcome: pulp vitality) after 18 months of
follow-up according to the different groups
PDR
SW
Total
Success
Failure
Total
Lost to
follow-up
111 (99)
87 (86)
194 (91)
1 (1)
14 (14)
19 (9)
112
101
213
41
45
86
p value
0.016*
Figures in parentheses are percentages. * 2 test.
Table 3. Logistic regression analysis final model with pulp sensi-
tivity as the dependent variable
Variable
Treatment (PDR-SW)
Filling material (AM-RC)
Age
Gender
Number of surfaces
Size of cavity
Family income
p
0.000
0.423
0.589
0.887
0.092
0.120
0.991
95% CI
lower
upper
0.010
0.503
0.900
0.294
0.833
0.116
1.000
0.268
5.142
1.062
2.887
11.480
1.280
1.000
Age and family income were treated as continuous variables.
All the other variables were categorical. AM = Amalgam; RC =
resin composite.
After 18 months of treatment, 213 restorations were
evaluated, 73% of the PDR group and 69% of the SW
group (fig. 1), indicating 99 and 86% success in the PDR
and SW groups, respectively (p = 0.016) (table 2). There
was 1 failure in the PDR group due to pulpitis. In the SW
Partial Removal of Carious Dentine:
18-Month Follow-Up Results
Values are expressed as means 8 SD. p = 0.0000.
group, there were 14 failures: 8 pulpitis; 1 osteitis; 4 necrosis; 1 endodontic treatment. No differences were observed between followed and nonfollowed cases regarding age, number of surfaces included in the restoration,
treatment and income (p 1 0.05). The main reason for the
loss to follow-up was loss of contact.
During the treatment of SW cases, 4 cases of pulp exposure were observed. One pulp exposure occurred at
the first appointment of the SW and the other 3 occurred
at the second appointment. Three cases were treated
with direct pulp capping and 1 case received endodontic
treatment right after the pulp exposure. After 18 months,
of the 4 patients who presented pulp exposure, 2 presented irreversible pulpitis and 1 patient maintained pulp
sensitivity. No pulp exposure was observed in the PDR
group.
In the final logistic regression analysis, none of the
variables exhibited a significant causal influence on the
success rate besides the type of treatment (table 3).
The time taken to perform the treatments was different between the groups. The PDR group had a faster overall treatment time since treatments took 39% less time
than the SW group (table 4).
Discussion
In the present study, 2 treatments for deep carious lesions, namely, SW performed in 2 (or 3) sessions, and
PDR performed in a single session, were tested. After 18
months of follow-up, the results show that PDR was more
effective than SW in preserving pulp vitality. Moreover,
age, gender, family income, filling material, and number
of surfaces of the restoration were not correlated with
treatment success (table 3).
SW was chosen to be the control treatment because of
the possibility of avoiding pulp exposure and its established high rate of success in several studies dealing with
deep caries lesions [Magnusson and Sundell, 1977; Leksell et al., 1996; Bjørndal and Thylstrup, 1998]. The alterCaries Res 2013;47:103–109
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SW
108
Caries Res 2013;47:103–109
is also reported in longitudinal direct pulp capping studies [Al-Hiyasat et al., 2006; Dammaschke et al., 2010].
Bjørndal and Thylstrup [1998] report a 93.4% success
rate of SW after 1 year of follow-up (including pulp exposures at the final excavation), which is a better result than
that found in the present study (86.14% success after 18
months). However, in another study involving 1 year of
follow-up, Bjørndal et al. [2010] reported a lower success
rate of SW compared to the present study. In the present
study, most of the failures in the SW group occurred in
patients who did not return at the appropriate time to receive the second step of the treatment, leading to temporary filling failure followed by pulp injury. In the present
study, if the remaining carious dentine still exhibited active characteristics when the tooth was reopened and offered a risk of pulp exposure during the final excavation,
a new temporary filling was placed. After a 30-day period, the tooth was reopened and the final excavation was
performed. This may explain the difference between the
pulp exposure rates from the study of Bjørndal et al.
[2010] (17.5%) and the present study (2.7%).
The 95% success rate after PDR found in the present
study is concordant with the results of Oliveira et al.
[2006] who reported a success rate of 97% after 18 months
of follow-up after partial dentine removal in deep carious
lesions.
Conclusion
The retention of carious dentine does not adversely affect pulp vitality. Data from this 18-month study suggest
that the procedure of reopening the cavity to remove the
residual infected dentine is not necessary.
Acknowledgments
We thank the National Coordination of Postgraduate Education (CAPES), Brazilian Ministry of Science and Technology
through its agency, the National Council of Research (CNPq, process No. 40.3420/04-0), the Research Support Fund of Rio Grande
do Sul (FAPERGS, process No. 04/1531-8), and DFL (Rio de
Janeiro, Brazil), Ivoclar Vivadent (Schaan, Liechtenstein), SDI
(Bayswater, W.A., Australia) and Hu-Friedy (Chicago, Ill., USA).
Disclosure Statement
All authors declare that there are no conflicts of interest.
Maltz /Jardim /Mestrinho /Yamaguti /
Podestá /Moura /de Paula
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native to SW is direct pulp capping, which is a much less
effective choice for treating profound dentine lesions
with a success rate of 20% after 10 years of follow-up [Barthel et al., 2000]. The presence of carious dentine during
direct pulp capping is an important factor to be considered when evaluating studies on this treatment. Al-Hiyasat et al. [2006] reported an overall success rate of 60%
after 3 years for direct pulp capping; however, this rate
decreased to 33.3% if the treatment was performed after
carious exposure. The possibility of completely removing
carious tissue and causing pulp exposure was then considered unethical. Bjørndal et al. [2010] also reported a
low success rate after direct pulp capping in teeth with
deep carious lesions (31.8%). It should be stressed that this
result was obtained after only 1 year of follow-up. These
facts led the present authors to consider SW as the gold
standard treatment for deep caries lesions at the beginning of this study.
It is important to stress that the present study is the
first longitudinal randomized clinical trial on permanent
teeth with deep caries lesions using a control group. The
other studies involving partial removal of deep caries lesions were conducted without proper control groups
[Maltz et al., 2002] or with deciduous teeth [Ribeiro et al.,
1999].
Regression analysis indicated no associations between
treatment success and the variables studied. Since after
2 years most studies show a high rate of success regarding
quality and survival of restorations, it seems reasonable
that the number of surfaces involved in the cavity or the
filling material used did not have a positive association
with the success of the treatments. Maltz et al. [2011]
showed that after 18 months of follow-up there was no
relationship between the number of surfaces involved
and the success of the partial caries removal treatment.
However, after 10 years, all failure cases (n = 10) presented class II restorations, whereas from the 16 success cases,
12 presented class I restorations.
The age of the patients was also a nondeterminant factor to the outcome evaluated; the patients in whom failures occurred in this study were between 6 and 53 years
old. In the present study, 13 and 5 failure cases involved
patients !20 and 120 years of age, respectively. In some
studies, age is considered an important factor when it
comes to deep caries lesions because of the pulp cells being more active in younger teeth [Murray et al., 2002].
Bjørndal and Thylstrup [1998] performed SW procedures
in patients in the age range of 11–65 years; after 1 year of
follow-up, they found no relationship between age and
treatment success. The lack of influence of age in results
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Partial Removal of Carious Dentine:
18-Month Follow-Up Results
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