CRITICAL APPRAISAL

2015 Update: Approaches to Caries Removal

Author
WILLIAM D. BROWNING, DDS, MS*
Associate Editor
EDWARD J. SWIFT, JR., DMD, MS

Every day in the United States and around the world, complete caries removal in vital, asymptomatic teeth with deep caries
lesions ends in unavoidable exposure of the pulp. As a result, the complexity and cost of treatment increase dramatically, and
many patients are left with extraction as their only viable option.This Critical Appraisal updates a previous appraisal (2013).
Since that review three, systematic reviews of the literature and one large, randomized controlled clinical trial (RCT) have
been published.Thus, newer, higher quality evidence is available that supports alternative treatments designed to preserve
the vitality of the tooth and thus avoid extraction.

Treatment of Deep Caries Lesions in Adults: Randomized Clinical Trials Comparing Stepwise
versus Direct Complete Excavation, and Direct Pulp Capping versus Partial Pulpotomy
L. BJRNDAL, C. REIT, G. BRUUN, M. MARKVART, M. KJLDGAARD, P. NSMAN, M. THORDRUP, I. DIGE, B.
NYVAD, H. FRANSSON, A. LAGER, D. ERICSON, K. PETERSSON, J. OLSSON, E.M. SANTIMANO, A.
WENNSTRM, P. WINKEL, C. GLUUD
European Journal of Oral Sciences 2010 (118: 2907)

ABSTRACT
Objective: The stepwise approach to caries removal was
compared with direct complete excavation at one year
in people who had received treatment for deep caries.
Materials and Methods: A multicenter, prospective,
parallel group, randomized clinical trial was conducted
to compare the results of stepwise and direct complete
caries excavation. Treatments were assigned using a
prearranged, randomly generated list. To help assure
comparable groups, the randomization sequence was
carried out in blocks of six participants and was
stratied for pain, age, and the center at which care was
provided. Patients were unaware of the treatment

received. Three hundred and fourteen participants were

studied. Lesions involved 75% or more of the dentin
and had a well-dened radiodense zone between the
caries and the pulp. Pulp vitality was conrmed using
thermal and electrical pulp testing procedures. Those
participants for whom treatment resulted in a pulp
exposure were invited to take part in a clinical trial that
compared the ecacy of pulp capping with that of
partial pulpotomy. Here again treatment was randomly
assigned.
For both the direct and stepwise approaches, the bulk
of caries removal was performed using a round bur,
with nal excavation being completed using hand
instruments. Even though the dentin might be yellowish

*Professor and Indiana Dental Association Endowed Chair, Department of Restorative Dentistry, Indiana University School of Dentistry, Indianapolis, IN, USA
The article was previously published in early view before the change.

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or grayish in color, caries was considered completely

removed when the remaining dentin hardness was
equal to normal dentin as determined by gentle
probing.
Stepwise excavation was carried out in two visits. At the
rst visit, the peripheral, demineralized dentin was
completely excavated, but in the deeper part of the
lesion only supercial, necrotic, and demineralized
dentin were removed. Excavation close to the pulp was
avoided. Soft, wet, discolored dentin was left in the
central aspect of the pulpal oor. A liner of calcium
hydroxide was used, and a temporary restoration of
glass ionomer cement was placed. At the second
appointment 8 to 12 weeks later, the lesion was
reentered, caries removal was completed, a calcium
hydroxide liner was placed, and a denitive restoration
using bonded composite was provided.
In the direct complete excavation group, all caries was
removed in one visit. However, to make the two groups
more nearly identical, calcium hydroxide and glass
ionomer cement were provided as described for the
rst appointment in the stepwise excavation group, and
participants were scheduled to return in 8 to 12 weeks.
At this second visit, the provisional material but not the
calcium hydroxide was removed, and a bonded
composite restoration was placed.
For both groups, when nal excavation led to a pulp
exposure, subjects were invited to participate in the
pulp capping trial. Those who accepted were randomly
assigned to have either a direct pulp cap or a partial
pulpotomy. A rubber dam was placed, the area was
cleaned using a solution of alcohol and chlorhexidine,
and irrigated with sterile saline. For those in the direct
pulp cap group, after hemostasis was obtained, a
calcium hydroxide cement was placed. For those in the
partial pulpotomy group, 1 to 1.5 mm of coronal pulp
tissue was removed using a high-speed diamond bur,
and calcium hydroxide was placed. Finally, a glass
ionomer temporary restoration was placed and the
participant was reevaluated after 1 month. At the
1-month evaluation, a thin layer of glass ionomer was
maintained to protect the area of pulpal treatment and
a bonded composite restoration was placed.

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There were three outcomes of interest for the caries

excavation trial:
The rst was evaluation at 1 year to determine
whether the treatment was a success or a failure.
Success was dened as the absence of a pulp
exposure during excavation, a vital pulp, and no
evidence of an apical radiolucency.
The second outcome of interest was the extent of
pain relief from pretreatment levels. Using a 100-mm
visual analog scale, the change in pain level from
preoperative levels to those at 1 and 7 days following
excavation was calculated.
The third was the presence of a pulp exposure during
excavation.
For the pulp capping trial, the only outcome of interest
was a vital pulp with no evidence of an apical
radiolucency at 1 year. Any patient who required a
complete pulpectomy procedure due to unbearable pain
was considered a failure.
Results: Outcome #1 and #3: At 1 year, 74% and 62% of
participants in the stepwise and direct excavation
groups, respectively, were found to have a vital pulp
with no apical radiolucency. Further, 18% and 29% of
participants in the two groups experienced a pulp
exposure during excavation. The stepwise excavation
group experienced a 12% advantage in success rate, and
in reduction of pulp exposures of 11%. Both dierences
were statistically signicant. Outcome #2: Among
patients with pretreatment pain, the degree of pain
relief at both day 1 and day 7 was low, and there were
no signicant dierences between the two groups.
Outcome for pulp capping trial: Following pulp
exposure during excavation, 22 participants received a
direct pulp cap procedure and 29 a partial pulpotomy.
Pulp capping resulted in a success rate of 32% and
pulpotomy 35%. There was no signicant dierence
between the two treatment groups. Additional ndings:
Considering only those participants whose treatment
did not result in a pulp exposure, 90% of the teeth were
treated successfully, and there was no signicant
dierence between the two groups. Relative to those
without preoperative pain, those with preoperative pain
were (1) signicantly more likely to experience a pulp

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exposure and (2) signicantly less likely to be classied

as a success at 1 year. Participants under 50 years of age
appeared to be more likely to be evaluated as a success
at 1 year, but the dierence was not signicant.
Conclusion: In conclusion, the stepwise excavation group
had a signicantly higher proportion of unexposed
pulps with sustained vitality and without apical
radiolucency than those with direct complete
excavation of deep caries lesions in adult teeth.

COMMENTARY
Worldwide, both the approach to treatment of deep
caries lesions and the terminology vary considerably. In
the present study, neither group was treated using a
partial caries excavation approach. Rather, the goal of
both treatments was to remove all caries, even if the
procedure resulted in a pulp exposure. In the stepwise
group, treatment was accomplished over two separate
appointments, whereas in the direct group it was
accomplished in one visit. The use of a calcium
hydroxide liner and the placement of a provisional glass
ionomer for 8 to 12 weeks were aimed at promoting
reparative dentin. Calcium hydroxide was believed to be
an important aspect of treatment in terms of
controlling the microora and stimulating the pulp. In
some of the literature, this approach is called an
indirect pulp cap. It is important to note that at this
rst visit the intent is to return to remove all caries, and
the liner and base are provisional.
Indirect pulp capping is a term used to describe a
procedure that is somewhat similar. But here the intent
is entirely dierent and all procedures are completed in
one visit. Obviously the terminology can be confusing,
and the reader must focus on whether the intent is to
remove all decay and how many visits are involved. The
most important dierence to consider is intent. Under
this terminology, at the start of the procedure the plan
is to remove all decay in one visit. However, once the
practitioner becomes convinced that complete caries
removal will cause an exposure, his/her objective for
the visit changes. Rather than expose the pulp,
excavation is stopped and a calcium hydroxide liner is
placed. A denitive restoration, not a provisional, is

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placed. Here the calcium hydroxide is considered the

key to success, and sealing the dentin is not a focus. All
procedures are completed in one appointment. No
further attempt is planned to reenter the tooth and
remove the remaining caries.
The term one-step partial caries excavation is
currently used to describe an almost identical approach,
but there are important dierences. The initial plan is
to leave some caries and place a denitive restoration
that seals the dentin, all in one visit. Here the operator
prefers to stays comfortably away from the pulp, rather
than trying to remove caries to the point where the
next use of the excavator will result in an exposure.
Calcium hydroxide may or may not be used. Although
some practitioners believe it is a critical element, the
literature indicates it is not necessary but not
detrimental. The keys are to avoid the pulp and seal the
dentin.
For studies in this eld, two outcomes of interest are
commonly tracked: pulp exposures during and pulpal
symptoms following the excavation procedure. The
outcomes chosen for the present study are dierent in
an important way. The authors evaluated participants at
1 year post-treatment, and dened success as continued
vitality with no signs of periapical pathology. While
data on pulp exposures were collected, they were not of
primary importance. In most studies, once the pulp is
exposed, the participant is excluded from further study.
Thus, data relative to any pulpal symptoms the
participant may have experienced are not collected.
Following exposure, roughly two-thirds of pulp capping
and partial pulpotomy treatments result in failure. It is
critically important to note that teeth with pulp
exposures are more likely to experience pulpal
symptoms. Accordingly, the decision to discontinue
collecting data regarding pulpal symptoms for
participants following an exposure is highly likely
to result in underestimating the proportion of
participants who experienced pulpal symptoms.
Importantly, where one technique results in
signicantly fewer exposures, the exclusion of
participants with pulp exposures fails to capture the
true dierence, in terms of pulpal symptoms, between
the two (or more) treatments.

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Ways of Enhancing Pulp Preservation by Stepwise ExcavationA Systematic Review

M. HAYASHI, M. FUJITANI, C. YAMAKI, Y. MOMOI
Journal of Dentistry 2011 (39:95107)

ABSTRACT
Objective: This was a systematic review aimed at
identifying the best possible methods and materials for
stepwise excavation of deep caries in permanent teeth,
including criteria such as clinical success, reduction of
cariogenic bacteria, prospects for hardening softened
dentin, the length of time required to harden softened
dentin, and the likelihood of generating tertiary dentin.
Materials and Methods: A search of the literature was
conducted to identify RCTs and controlled clinical trials
(CCTs) related to deep caries lesions, that is, lesions
where, if the caries were completed removed, pulp
exposure would be the likely result. If the number of
RCTs and CCTs were limited, case series that describe
longitudinal clinical prognoses would be included.
Studies were sought that used complete caries removal
or dierent pulp capping agents as a control group.
Studies of primary teeth were excluded. Two
independent evaluators screened abstracts for inclusion
according to a predetermined set of inclusion and
exclusion criteria.
Results: Thirteen articles were identied. Two were
RCTs, ve were CCTs, and six were longitudinal case
series without a control group. None of the studies
clearly dened either how much carious dentin was
removed or how much infected dentin remained in the
cavities. Calcium hydroxide was used as a liner in 11 of
the 13 articles, while the remaining two studies used
antimicrobials, such as chlorhexidine or thymol
containing varnish, as well as demeclocycline
hydrocortisone or polycarboxylate cement with
tannin-uoride preparation. The time delay before
reentering the lesion ranged from 4 weeks to 12 months.
In the eight studies that reported this outcome, clinical
success rates between 94% and 100% were reported.
Dierences in success rates among the dierent lining

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materials were not signicant. In the ve studies that

reported on the condition of the dentin upon reentry,
all reported the softened dentin had become darker,
harder, and drier. Four studies included radiographic
examinations, all reporting increased radiodensity
suggesting remineralization. One study reported the
generation of tertiary dentin among a small percentage
of the cases at 6 months post-treatment.
Conclusion: From this review, stepwise excavation can be
concluded as eective for pulp preservation in
extremely deep caries where there are no clinical
symptoms of irreversible pulpitis.

COMMENTARY
A systematic review of randomized clinical trials is the
highest form of evidence available to guide practitioners
in choosing the most eective treatments. Some
reviews are qualitative, simply reporting the results
from all the included studies. Others are quantitative,
statistically combining the results of all included studies
via a meta-analysis of the data. Whether the systematic
review is qualitative or quantitative, the individual
studies must be similar enough that it makes sense to
combine them. Generally, systematic reviews combine
individual studies on the basis that all used reasonably
similar study designs, but more importantly that all
reported the same outcome(s) of interest. For this
particular topic, that might be continued vitality,
whether or not the pulp was exposed, the presence of
pulpal symptoms, reports of pain, radiographic evidence
of a periapical defect, etc.
The present review has some critical weaknesses that
must be evaluated when considering its value. First,
almost half of the studies included in the review did not
include a control group and more than three-quarters
did not include randomization. The inclusion of a
control group, randomization of participants to the

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various treatments, and concealment of the participants

group status from the operator and the participant him/
herself increase the quality and thus the reliability of
research dramatically. Accordingly, the lack of a control
group and randomization means the underlying studies
are relatively weak, and combining weak studies together
does not somehow create strong, high-quality evidence.
Second, stepwise excavation is not clearly dened in the
Materials and Methods section. Within the table
describing the 13 included studies, only two studies
specically list a stepwise approach to removing all
caries. Others describe partial or peripheral caries
removal, or simply list the procedure used as stepwise
caries excavation. As noted previously, terminology in
this eld is evolving and can be confusing. The literature
includes studies that use a stepwise approach to partial
caries excavation. However, more often that terminology
describes two-step complete caries excavation. The fact
that some studies might have removed all caries while
others left some caries creates questions about the
appropriateness of combining these studies.
The written report does not provide a clear, transparent
description of how the review was conducted. Clinical

success is reported to range from 94% to 100%.

However, for neither this group of studies as a whole
nor for the individual studies was clinical success ever
dened. Similarly, the authors state that there was no
dierence in success rates for the various lining
materials used, but there is no description of how these
results were combined or the statistical test used to
compare them. There are similar issues with the data
related to remineralization. The authors state that all
the studies that reported data on remineralization
found increased radio density, but there is no report of
how this was measured.
In summary, the dental profession has a paucity of
clinical trials, and those we do have are generally small.
Combining 13 studies clearly provides a means to
generate a larger set of data and the potential benets
are obvious. However, rather than the quantity, it is the
quality of the information that is still our primary
concern. This systematic review combines several
publications that appear to be quite dierent.
Importantly, in my opinion, the written report does not
provide sucient information about the review process
for the reader to be comfortable that combining these
publications made sense.

Operative Caries Management in Adults and Children

D. RICKETTS, T. LAMONT, N.P.T. INNES, E. KIDD, J.E. CLARKSON
Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD003808. DOI: 10.1002/14651858.CD003808.pub3

ABSTRACT
Objective: To assess the eects of stepwise, partial, or no
dentinal caries removal compared with complete caries
removal for the management of dentinal caries in
previously unrestored primary and permanent teeth.
Materials and Methods: This was a systematic review
with meta-analysis that included only RCTs. Included
were randomized and quasi-randomized and
split-mouth and independent group trials. Three
proceduresstepwise caries removal, partial caries
removal, and no dentinal caries removalwere all

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compared with complete caries removal. These studies

included lesions in both primary and permanent teeth
and on any surface in a previously unrestored tooth. A
thorough search of several databases and hand searches
of relevant articles was conducted. Authors were
contacted regarding unpublished data and for missing
data. The articles were evaluated for inclusion, and data
were extracted using multiple reviewers whose
decisions were made based on guidelines established
prior to the start of the project.
For each article included in the review, three
independent reviewers assessed the study for bias.

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Specically three issues were assessed: 1) how

treatment assignments were generated; 2) how well
assignment to a specic treatment was concealed before
the start of the study; and 3) during the study, how well
the group identify of each participant was concealed
from the participant, the operators performing the
evaluation and the sta. In addition, articles were
evaluated for the presence of incomplete outcome data
and selective reporting of only some of the outcomes.
Risk was categorized as low, unclear, and high. Bias
ratings were dened as follows:
Low: bias unlikely to seriously alter the results
Unclear: one or more of the domains was assessed as
unclear
High: bias weakens condence in the results; one or
more of the domains was assessed as being at high risk
of bias
The I2 statistic was used to investigate the heterogeneity
of the estimates of the treatment eect among the
various studies. This test described the percentage of
total variation that was due to heterogeneity between
the included studies rather than to chance.
Four primary outcomes were studied: (1) exposure of
the pulp during caries removal, (2) signs and symptoms
of pulpal disease, (3) progression of caries, and (4)
restoration failure. Binary data from studies
reporting the same outcome measures were
combined and analyzed using risk ratios.
Continuous data were analyzed using a random-eects
model.
Results: Six hundred and ninety titles, including four
identied by hand searching, were identied as
potentially relevant to the review. After initial
assessment, 30 full-text articles were evaluated. Eight
trials involving 934 people and 1,191 teeth were
analyzed for the review. Four studies included only
primary teeth, three only permanent teeth, and one
included both. Most patients were children. There was
no standardization of reporting of the depth of lesions.
One study included only occlusal lesions, one
predominately occlusal-proximal lesions, and four
studies included both. For two studies, the report

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suggests only occlusal lesions were included, but the

text is unclear.
Two studies did not remove any dentinal caries. In the
three studies that used stepwise excavation, the interval
between the two appointments varied between 4 and 24
weeks. Similar variations were observed in the approach
to the amount of caries removal at the initial
appointment. Two studies removed decay until the
operator felt there was signicant risk of exposure.
Another removed only supercial necrotic and
demineralized dentin while avoiding excavation close to
the pulp. In the two studies that investigated partial
caries removal, the enameldentin junction was
completely cleared of caries, but only supercial
necrotic dentin was removed from the pulpal and axial
walls. Five studies reported exposure of the pulp and
seven on signs and symptoms of pulpal disease at 1
year. Six studies reported on restoration failure; for two,
this was the studys major focus. None of the studies
reported on the progression of caries.
Rather than rate each study as a whole, a rating for
each of the potential sources of bias noted above was
provided. It was also noted that if an overall rating of
bias for each of the studies had been made, it would
have been high. The diculty of completely controlling
bias in a clinical was also noted.
Outcome #1: Pulp exposure
Stepwise excavation versus complete caries removal
Stepwise excavation, relative to complete caries
removal, resulted in signicant reductions in risk ratio.
Considering both the primary and permanent teeth, the
risk ratio was 0.44. Considering only primary dentition,
it was 0.31, and for permanent dentition 0.51. The
quality of the evidence was considered moderate.
Partial caries removal versus complete caries removal
Overall, the risk ratio was 0.23. For primary teeth, it
was 0.24. Both were statistically signicant, and
the quality of the evidence was considered
moderate.

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No caries removal versus complete caries removal

Because no caries was removed in these studies, there
was no risk of pulp exposure for that group of
participants. As a result, there were insucient data
reported to make a comparison in terms of pulp
exposure.
Outcome #2: Signs and symptoms of pulpal disease
Stepwise excavation versus complete caries removal
Only two of the trials contributed data to this
meta-analysis. One included only permanent teeth and
the other both primary and permanent teeth. The risk
ratio was reported as 0.78 and was not statistically
signicant. The quality of the evidence was considered
moderate.
Partial caries removal versus complete caries removal
Three trials provided data for this analysis. The risk
ratio was 0.27 and was not statistically signicant. The
quality of the evidence was considered low.
No caries removal versus complete caries removal
Here again very few pulpal symptoms were experienced
by either group, and thus no testing was performed.
Outcome #3: Progression of caries
While the authors hoped to investigate this outcome,
none of the studies reported any data and thus no
testing was possible.

the other. Accordingly, there was insucient evidence

to determine if a dierence in restoration failure
existed.
No caries removal versus complete caries removal
Two studies contributed data on this outcome. One
reported on only primary teeth and one on permanent
teeth so it was not appropriate to combine the data.
Conclusions: The current evidence demonstrates that in
symptomless, vital, carious primary or permanent teeth,
stepwise and partial excavation reduced the risk of pulp
exposure. Therefore, these techniques have clinical
advantages over complete caries removal in the
management of dentinal caries. While there is
insucient evidence to determine whether it is
necessary to reenter and excavate further in the
stepwise excavation technique, the studies that did not
reenter reported no adverse consequences.

COMMENTARY
Traditional literature reviews, while attractive as a
source of information, are basically a form of expert
opinion, and as such represent a weak form of evidence.
While taking advantage of the expertise of someone
who works and studies in a given eld oers obvious
advantages, it also brings with it the preconceived
notions of the expert(s). Too often, it is the nature of
experts to believe that their extensive knowledge
of the subject means that the impressions
formed from a lifetime of study are as reliable as actual
data.
Systematic reviews overcome this weakness by:

Outcome #4: Failure of restorations

Stepwise excavation versus complete caries removal
No testing was reported.
Partial caries removal versus complete caries removal
Only two studies reported data on this outcome, and
there was one failure reported in one study and none in

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Making an exhaustive eort to include all relevant

articles, not just those the author(s) believe are
worthy or support their preconceived outcome
Dening in advance and outlining in detail each and
every step of the process, for example, inclusion and
exclusion criteria for the studies, which outcomes are
of interest, how the data are to be combined, how
disagreements among reviewers are to be resolved,
etc.

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Providing the reader a transparent and highly

detailed report of the whole process
Statistically combining data from the various studies.
This step, as opposed to a systematic review that is
only qualitative in nature, represents, in my opinion,
a dramatic increase in the reliability of the reviews
conclusions and thus the strength of the evidence.
This systematic review is clearly dierent from the
previous article. In the present article, the description of
each step is very detailed. It might appear that since all
included studies used complete caries removal as the
control group, the data could all be combined into one
large meta-analysis procedure. It is important to note
that these authors analyzed separately data from studies
that used stepwise excavation, partial caries excavation,
and no caries removal. This approach was appropriate
because qualitatively the three approaches to caries
removal were too dissimilar. In addition, prior to any
meta-analysis for each outcome, the studies relevant to
that particular question were statistically analyzed to
assure there was no problem with heterogeneity. The
contrast between this systematic review and the
previous article makes it clear that even though the
systematic review is the highest form of evidence
available to us, one must still be a critical consumer of
information.
Within several of the reports for each of the various
outcomes, there was a comment similar to this one:
The quality of the evidence was considered moderate.
Reviews like this oer the profession the highest
evidence with which to make treatment decisions. This
evidence is dramatically stronger than the kinds of
casual conclusions we are often limited to: clinicians
anecdotal observations made while they are busy
treating patients; and they are clearly more relevant
than the results of lab studies, as lab studies have never
been shown to be predictive of clinical results. Given
that systematic reviews are our highest form of
evidence, it may be confusing to understand why the
results of a specic test provide only moderate quality
evidence.
The statement about being the highest possible
evidence compares the systematic review with other

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study designs, while the moderate quality rating

compares a particular study/result with what might be
expected under ideal conditions. The quality ratings are
very low, low, moderate, and high. Examples of
problems negatively aecting the grade of the evidence
include lack of standardization of the amount of decay
left during partial caries excavation, lack of data
regarding the progression of caries, and wide
condence intervals resulting from a lack of available
data. Thus, the results of this systematic review do not
oer perfect evidence. When one considers how
dicult it would for investigators to stop caries removal
when there was exactly 2.0 mm of remaining carious
dentin or to accurately measure the amount of
remaining carious dentin and mathematically calculate
changes from baseline to subsequent evaluations, it
seems clear that no clinical trial is likely to overcome all
these diculties. These authors recognize this as well.
The larger point is that despite these problems
systematic reviews of clinical trials are far more
reliable than any of the individual studies reviewed
and any of the types of studies listed lower on the
evidence pyramid than systematic reviews of clinical
trials.
As noted in the comments relative to the Bjrndal
study, most studies in this eld dismiss participants
who have an exposure from further participation in the
study. As a result, while studies report sizable and
statistically signicant dierences in the number of pulp
exposures, the data for signs and symptoms of pulp
disease are generally less impressive and seldom
signicant. Similar to the comments in this appraisal
relative to the Bjrndal study above, Ricketts and
coauthors note this phenomenon as being a weakness
in the present literature. The Ricketts review clearly
supports the conclusion that partial caries excavation
will lead to fewer exposures; that is hardly a startling
revelation. But it does not provide support similar in
terms of pulpal health, and some may conclude there is
no advantage in terms of postoperative pulpal
symptoms. In my opinion, this interpretation does not
take into account all the available science. It is clear
that exposed pulps treated with pulp capping or partial
pulpotomy have a low rate of success (about 1/3).
Accordingly, teeth with pulp exposures are the ones

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most likely to result in signs and symptoms of pulp

disease. In terms of a reduction in pulpal symptoms,
there is a lack of evidence to support partial caries
excavation rather evidence that demonstrates there is
no dierence between the two treatments. This lack of
evidence is a direct result of the way clinical trials have
been conducted to this point.
Here are two closing observations regarding risk
ratios, odds ratios, and 95% condence intervals,
which are very common to systematic reviews. First,
let us consider the overall risk ratio comparing pulp
exposures using partial caries excavation versus
complete caries removal, which was reported as 0.23.
For those unfamiliar with this statistic, that means for
every 100 pulp exposure one would experience using
complete caries removal, one would only see 23 using
partial caries excavation. One will often see this type
of data also reported as a 77% reduction in exposures.
While this is useful statistics, it probably is not
obvious to most of us how one gets from a risk ratio
of 0.23 to a 77% reduction. Statistics start with an
assumption that there is no dierence between the
two treatments. As a result, variations in the data
from one group to the next are viewed as a result of
chance alone (the null hypothesis). If the two caries
removal techniques both resulted in 25 exposures per
100 patients, the ratio would be 25 divided by 25 or
1.0. Here instead of the expected ratio of 1.0, it is
0.23. Clearly, partial caries excavation resulted in a
reduction from the expected 1.0, and the amount of
reduction is calculated as follows ([1.000.23] 100)
or 77%. Both of these statistics present data in
a form that is much more user-friendly to
practitioners whose focus is on the results they are
likely to achieve using one procedure rather than the
other.
Second is the use of condence intervals. The result for
the comparison of partial caries removal to complete
caries for the outcome signs and symptoms of pulpal
disease is illustrative. As noted above, the risk ratio was
0.27. That is a 73% reduction and appears to represent a
clinically important dierence. However, the condence
interval tells a dierent story. It is quite large, 0.05 to
1.60, and the review states that the results were not

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signicant (p > 0.05). The size of the condence interval

is, in large part, due to the small size of the available
dataset. The fact that even after combining several
studies the data are insucient illustrates how dicult
the pursuit of ideal evidence is. In order to fully take
advantage of the benets of evidence-based dentistry
(EBD), the dental profession needs more clinical
trials!

SUGGESTED READING
Bjrndal L, Reit C, Bruun G, et al. Treatment of deep caries
lesions in adults: randomized clinical trials comparing
stepwise vs. direct complete excavation, and direct pulp
capping vs. partial pulpotomy. Eur J Oral Sci
2010;118(3):2907.
Innes NP, Evans DJ, Stirrups DR. The Hall technique; a
randomized controlled clinical trial of a novel method of
managing carious primary molars in general dental
practice: acceptability of the technique and outcomes at 23
months. BMC Oral Health 2007;7(18):121.
Leksell E, Ridell K, Cvek M, Mejare I. Pulp exposure after
stepwise versus direct complete excavation of deep carious
lesions in young posterior permanent teeth. Endod Dent
Traumatol 1996;12:1926.
Lula EC, Monteiro-Neto V, Alves CM, Ribeiro CC.
Microbiological analysis after complete or partial removal
of carious dentin in primary teeth: a randomized clinical
trial. Caries Res 2009;43:3548.
Magnusson BO, Sundell SO. Stepwise excavation of deep
carious lesions in primary molars. J Int Assoc Dent Child
1977;8(2):3640.
Mertz-Fairhurst EJ, Call-Smith KM, Shuster GS, et al. Clinical
performance of sealed composite restorations placed over
caries compared with sealed and unsealed amalgam
restorations. J Am Dent Assoc 1987;115:68994.
Orhan AI, Oz FT, Orhan K. Pulp exposure occurrence and
outcomes after 1- or 2- visit indirect pulp therapy vs.
complete caries removal in primary and permanent
molars. Pediatr Dent 2010;32:34755.
Ribeiro CC, Baratieri LN, Perdigao J, Baratieri NM,
Ritter AV. A clinical, radiographic, and scanning
electron microscopic evaluation of adhesive restorations
on carious dentin in primary teeth. Quintessence Int
1999;30:5919.

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Incomplete Caries Removal: A Systematic Review and Meta-Analysis

F. SCHWENDICKE, C.E. DRFER, S. PARIS
Journal of Dental Research 2013 (92:30614)

ABSTRACT

Outcome #1: Pulp exposure

Objective: This was a systematic review including

meta-analysis. Randomized and quasi-randomized
controlled trials (RCTs) for both deciduous and
permanent teeth that compared complete and
incomplete caries removal techniques were included in
the review.

Two-step incomplete excavation versus complete caries

removal

Materials and Methods: Studies published in 1967 or

later were eligible for inclusion. Eligible studies would
report on the following outcomes: (1) pulpal exposure,
(2) postoperative pulpal symptoms and signs of pulp
disease, and (3) clinical failure, for example,
complications demanding intervention, pulpitis,
restorations that required replacement or were lost, etc.
Eligible studies would include the following
interventions and controls: (1) incomplete caries
removal (one or two steps), (2) indirect pulp
treatment or capping, and (3) complete caries
removal.
Searching was done using multiple literature databases
and by hand searching. Data extraction was performed
and a bias assessment for each included study was
made. Extracted data for pulp exposure, pulpal
symptoms, and failure were recorded as binary data,
and odds ratios were reported. Heterogeneity was
assessed using I2 statistic.
Results: Database searches identied 332 articles that
were possibly eligible for inclusion. An additional 32
studies were identied by hand searching. After
screening all the abstracts, 87 full-text articles
were obtained and evaluated. Finally, 10 eligible
studies were included. The studies represented
1,257 patients and 1,628 teeth. It was noted
that the amount of carious tissue removed varied
considerably.

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The odds ratio and 95% condence interval was 0.35

(0.220.56), and the quality of the evidence was
considered moderate.
One-step incomplete excavation versus complete caries
removal
The odds ratio and 95% condence interval was 0.20
(0.060.61), and the quality of the evidence was
considered low.
One- and two-step incomplete excavation versus
complete caries removal (pooled data)
The odds ratio and 95% condence interval was 0.31
(0.190.49), and the quality of the evidence was
considered moderate.
Outcome #2: Postoperative pulpal symptoms
Two-step incomplete excavation versus complete caries
removal
Data for one- and two-step treatments had to be pooled.
One-step incomplete excavation versus complete caries
removal
Data for one- and two-step treatments had to be pooled.
One- and two-step incomplete excavation versus
complete caries removal (pooled data)
The odds ratio and 95% condence interval was 0.58
(0.311.10), and the quality of the evidence was
considered low.

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Outcome #3: Failure of restorations

Two-step incomplete excavation versus complete caries
removal
Data for one- and two-step treatments had to be
pooled.
One-step incomplete excavation versus complete caries
removal
Data for one- and two-step treatments had to be
pooled.
One- and two-step incomplete excavation versus
complete caries removal (pooled data)
The odds ratio and 95% condence interval was 0.97
(0.641.46), and the quality of the evidence was
considered very low.
Conclusions: Incomplete caries removal seems
advantageous, particularly in the treatment of caries in
close proximity to the pulp, because it signicantly
reduces the risks of pulpal exposure and postoperative
pulpal symptoms compared with complete excavation.
There is currently no evidence that incompletely
excavated teeth are more prone to complications.

COMMENTARY
This systematic review considers six studies included in
the Ricketts review above. It does not include the Innes
study or the Mertz-Fairhurst 1987 publication, but it
includes a 10-year (1998) Mertz-Fairhurst article. It also
adds three other studies not included in the Ricketts
review (Heinrich, Foley, and Phonghanyudh). Both
groups of authors conducted very thorough searches of
the literature on this topic. Rather than resulting from
identifying studies that Ricketts missed, the dierences
in the choice of studies in the present review result
from the use of dierent inclusion and exclusion
criteria. One of the strengths of a systematic review is
that all of this critical information is fully described by
the authors, and readers of both these reviews can
evaluate the dierences in these criteria for themselves.

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In the present study, there were no groups comparable

to the stepwise excavation and the no caries removal
groups in the Ricketts review. However, the one-step
partial caries excavation data in the present review
compare directly with the partial caries removal data in
Ricketts. Despite including slightly dierent sets of
studies, the results for pulp exposure are very
comparableit is 0.23 in Ricketts review and 0.20 in
the present review. For the pulp exposure outcome, it is
interesting to compare the results from the one-step
and two-step approaches. The theory is that a two-step
approach allows time for remineralization and thus
reduces the number of exposures. Instead, the data
indicate that there is no advantage to reentering the
lesion and that it is better to remove whatever decay
you are going to in one visit. The reduction in
exposures taking a two-step approach was 65% and for
one-step it was 80%.
Six studies involving 680 patients contributed data to
the meta-analysis conducted for postoperative pulpal
symptoms. By contrast in the Ricketts review, there
were only two studies and 278 patients. As a result of
this larger sample, the estimated odds ratio is more
precise, 0.58 (0.311.10), versus that reported by
Ricketts, 0.27 (0.051.60). Despite reviewing only
studies that did not follow participants after a pulp
exposure, this review reported a signicant reduction in
pulpal symptoms relative to complete caries removal.
However, that report is somewhat confusing. While the
text of the review described the dierence as signicant,
the condence interval reported indicates that it was
not.
The use of condence intervals rather than means and
standard deviations oers two important advantages.
First, it reminds us that the estimate for the mean is not
the result every participant experienced or that you can
expect for your patients. The condence interval
indicates that we can be 95% condent that our patients
will experience a reduction somewhere between X and
Y. The second is that one can quickly determine
whether or not the ndings represent a statistically
signicant dierence between treatments. If the
condence interval does not include 1.0, then the result
is signicant, and if it does include 1.0 it is not. In the

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CRITICAL APPRAISAL Browning and Swift

present review, the text states the dierence was

signicant, but the condence interval indicates
that it was not, and there is no way to reconcile the
dierence.
After noting that participants with pulp exposure were
not followed for pulpal symptoms and the success rates
for pulp capping/pulpotomies is low, Schwendicke and
coauthors concluded that the inclusion of these teeth
would have led to a dramatic shift in the risk of failure.
They also noted that even with this exclusion,
incomplete excavation does not seem to have any
disadvantages compared with complete caries removal.
Finally, the authors discuss the fact that the literature
does not clarify whether longer intervals between rst
and second visits could reduce the risks of pulpal
exposure and complications, or if certain liners or
restorative materials oer an advantage in maintaining
pulp vitality.
Based on laboratory studies, one would expect
incomplete caries removal would have two negative
eects on restoration longevity. The rst would be poor
support for the restoration leading to fracture and the
second would be problems bonding to and sealing the
dentin. Accordingly, a priori one would expect the
longevity of restorations in teeth restored after
incomplete caries removal to be reduced. These authors
found it interesting that the trend of the data did not
support this expectation.
Given the professions shift toward evidence-based
practices, the issue of how to value various forms of
information is very topical. If I wish to reduce the
number of pulp exposures, evidence of the highest
strength possible clearly dictates that partial caries
excavation rather than complete caries removal is the
best treatment. However, for postoperative pulpal
symptoms, the results discussed in this Critical
Appraisal are more dicult to assess. If there is a clear
data trend indicating there may be a clinically
important dierence between treatments, but statistical
testing indicates the dierence is not signicant, how
should one interpret that? EBD provides a good
framework for making this sort of determination. At
present, some perceive EBD as an approach more

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focused toward academic dentistry than clinical

practice. But EBD is really a clinical tool, one that
recognizes that practitioners have an obligation to treat
and do not have the luxury to await perfect
information. I nd it easier to think about EBD as an
approach to practice that demands the use of the best
evidence available to guide treatment decisions.
Inherent in this approach is the acknowledgment that
not all evidence is created equal. For example, the
casual impressions of one practitioner should not be
given equal weight to those of another who carefully
studied the question by actually collecting data. As
practitioners, we would like to know positively which
treatment option is best. All in all, proof positive is not
a possibility, so instead we work with evidence rather
than proof. The best evidence we can hope for is the
results from a well-designed clinical study (studies) that
has found a statistically signicant association between
one treatment and a superior outcome. And more
typically, we have only lower strength evidence with
which to work.
In this Critical Appraisal, the two systematic reviews of
randomized clinical (1a on the evidence pyramid) trials
both indicate there is a clinically important reduction in
the risk of postoperative pulpal symptoms using partial
caries excavation. In addition, both note a problem with
current studies that tend to underestimate the impact
partial caries excavation has on reducing pulpal
symptoms. The randomized clinical trial conducted by
Bjrndal corrected this design aw and was able to
show a statistically signicant reduction in
postoperative pulpal symptoms. But it is slightly lower
(1b) on the evidence pyramid.
Some believe that EBD is designed to dictate treatment.
In my opinion, the practitioner must take all of the
available information into consideration. Even though
the results for this outcome were not statistically
signicant in the two systematic reviews, I conclude
that the use of partial caries excavation is very likely to
reduce the number of patients with exposures and
postoperative pulpal symptoms; that is, the best
available evidence indicates this is the best treatment
option. Weight is given to the fact that the two reviews
and the randomized clinical trial are at the highest level

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CRITICAL APPRAISAL Browning and Swift

of the evidence pyramid. The number of studies and

the sample size in the two systematic reviews are
important as well. One study with a small sample size
would not be persuasive, but a trend derived from a
large dataset is. More important is the mental approach
to the issue: This is the best evidence currently
available, and my patient needs this treatment. This
evidence has some aws, and it is possible that better
evidence may come along in the future which
contradicts it, but the answer to that concern is to
reconsider this clinical question periodically. Finally,
rather than considering this treatment choice a
as permanent answer to this clinical question,
I recognize there are aws and I will need to
be willing to change my approach if that is indicated in
the future.

SUGGESTED READING

In sum, I do not have and will never nd proof positive.

Here is what I do have: Two large datasets that indicate
no statistically signicant association (1a evidence)
between partial caries excavation and reduced
postoperative pulpal symptoms. The trend in data does
indicate that my patients are more likely than not to
benet from my using partial caries excavation. Also, it
is clear that the present literature is made up of studies
whose designs tend to underestimate the eectiveness
of partial caries excavation at reducing pulpal
symptoms. I do have statistical evidence from a single
randomized clinical trial associating (1b evidence) this
treatment with a reduction in pulpal symptoms.
Statistical evidence from the systematic reviews
indicates that complete caries removal was not superior
to partial caries excavation. So at worst, the two
treatments are statistically equivalent. Considering all of
these, it is enough for me to decide that partial caries
excavation is the best treatment option.

Magnusson BO, Sundell SO. Stepwise excavation of deep

carious lesions in primary molars. J Int Assoc Dent Child
1977;8:3640.

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Foley J, Evans D, Blackwell A. Partial caries removal and

cariostatic materials in carious primary molar teeth: a
randomised controlled clinical trial. Br Dent J
2004;197:697701.
Heinrich R, Kneist S, Kunzel W. Klinisch kontrollierte
Untersuchung zur Caries-profunda-Therapie am
Milchmolaren. Dtsch Zahnrztl Z 1991;46:581-4.
Leksell E, Ridell K, Cvek M, Mejare I. Pulp exposure after
stepwise versus direct complete excavation of deep carious
lesions in young posterior permanent teeth. Endod Dent
Traumatol 1996;12:1926.
Lula EC, Monteiro-Neto V, Alves CM, Ribeiro CC.
Microbiological analysis after complete or partial removal
of carious dentin in primary teeth: a randomized clinical
trial. Caries Res 2009 43:3548.

Mertz-Fairhurst EJ, Curtis JW, Ergle JW, Rueggeberg FA,

Adair SM. Ultraconservative and cariostatic sealed
restorations: results at year 10. J Am Dent Assoc
1998;129:5566.
Orhan AI, Oz FT, Orhan K. Pulp exposure occurrence and
outcomes after 1- or 2- visit indirect pulp therapy vs.
complete caries removal in primary and permanent
molars. Pediatr Dent 2010;32:34755.
Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen
PE. Clinical evaluation of three caries removal approaches
in primary teeth: a randomised controlled trial. Commun
Dent Health 2012;29:1738.
Ribeiro CCC, Baratieri LN, Perdigo J, et al. A clinical,
radiographic, and scanning electron microscopic
evaluation of adhesive restorations on carious dentin in
primary teeth. Quintessence Int 1999;30:5919.

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THE BOTTOM LINE

Compared with complete removal of caries in one visit (1b):
Stepwise removal of all caries provided significant reductions in pulp exposures and postoperative pulpal symptoms.
One- and two-step partial caries removal provided a significant reduction in pulp exposures.
The Bjrndal study followed participants after pulp exposure and thus was able to find a statistically significant
reduction in postoperative pulpal symptoms, whereas previously published literature did not follow participants after
exposure. Accordingly, the present literature probably underestimates the reduction of postoperative pulpal
symptoms that can be achieved using stepwise or partial caries excavation.
Compared with complete removal of caries in one visit, the data support the conclusion that one- and two-step
partial caries removal results in a reduction of postoperative pulpal symptoms (1a).
Success rates for pulp capping and partial pulpotomies are approximately one-third.
The literature in this field can be confusing. Noting whether caries excavation was complete or partial and the
number of visits involved is the best way to avoid confusion.
When taking a partial caries excavation approach, the data support the conclusion that there is no advantage to
reentering the lesion. The operator should simply remove all the decay he/she intends to remove at the first visit.
Systematic reviews of randomized clinical trials that include meta-analysis are the best form of evidence available to
guide practitioners in choosing the best available treatments.
One of the basic critiques the reader of a systematic review needs to make is whether or not it made sense to
combine the various studies. Were the studies similar enough in design, outcomes of interest, and treatment
techniques?
A best-evidence approach (EBD) is a great improvement over simply considering all available information as
equivalent. However, the practitioner must always be a critical evaluator. Systematic reviews can be done well or not
so well, and over time study designs improve. Several of the present papers demonstrate how clinical trials in the
field of postoperative pulpal symptoms have evolved, and that clinical questions tend to be complex, often requiring
one to combine evidence from several sources to gain a better understanding of the evidence.
Odds ratios and risk ratios are commonly used in systematic reviews. A risk ratio of 0.23 for partial caries
excavation versus complete caries removal indicates that for every 100 pulp exposures resulting from complete
caries removal, only 23 would result from using partial caries excavation.
Where treatments are equivalent, the odds ratio will be approximately 1.0. The odds ratio of 0.23 above can also be
interpreted as a 77% reduction in pulp exposures ([1.00.23] 100). The 95% confidence interval (CI) provides the
reader a means to quickly summarize how precise the estimate for the average outcome really is and whether the
results are significant or not. If the 95% CI does not include 1.0, it is significant and if it does, it is not.
Based on concerns over study design issues such as possible bias, difficult measurement issues, and available sample
size, the quality of the evidence provided for a specific outcome(s) can be graded. This grade is separate from
ratings based on the evidence pyramid, for example, 1a, 1b, 2a, 2b, etc. A well-conducted systematic review of
randomized clinical trials will always be stronger than a nonrandomized trial, a case-control study, etc.
Ratings of very low, low, moderate, and high are used to compare the strength of this evidence relative to a study
that contained no bias, no measurement issues, etc. The lower the grade, the more likely it is that subsequent review
may reverse rather than confirm the present evidence.

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