Received: 7 December 2018 

|  Revised: 26 March 2019 

|
  Accepted: 11 February 2020

DOI: 10.1111/ipd.12633

REVIEW

Outcomes of direct pulp capping in vital primary teeth with

cariously and non-cariously exposed pulp: A systematic review

Arturo Garrocho-Rangel1   | Vicente Esparza-Villalpando2  | Amaury Pozos-Guillen1,2

1
Paediatric Dentistry Postgraduate Program,
Faculty of Dentistry, San Luis Potosi
University, San Luis Potosi, SLP, Mexico
2
Basic Sciences Laboratory, Faculty of
Dentistry, San Luis Potosi University, San
Luis Potosi, SLP, Mexico
Correspondence
Amaury Pozos Guillén, Faculty of
Dentistry, San Luis Potosi University, Av.
Dr. Manuel Nava #2, Zona Universitaria,
San Luis Potosí, SLP C.P.78290, Mexico.
Email: apozos@uaslp.mx
Abstract
Objective: To summarize the clinical/radiographic outcomes from the evidence of
studies published since 1988 on different DPC agents applied on vital pulp–exposed
primary teeth.
Methods: The following electronic databases were searched: PubMed, Embase,
Cochrane Library, Dentistry and Oral Science Source, and Google Scholar. Inclusion
criteria were randomized controlled trials (RCTs) published between January 1988
and December 2019, with at least 6 months of follow-up, comparing the clinical and
radiographic success rates of two or more DPC agents applied in primary teeth with
cariously and non-cariously exposed pulp.
Results: Initial searches identified 83 potentially relevant studies on DPC in primary
teeth. Sixty-four of these studies were excluded, whereas 19 articles satisfied the in-
clusion criteria and were retrieved in full text for data extraction and a methodologi-
cal quality assessment. Finally, 12 of these articles were included in the systematic
review. Low and moderate risks of bias were observed. Overall, DPC clinical and ra-
diographic success rates among the selected studies ranged between 53% and 100%.
Conclusions: For DPC in primary teeth, this systematic review found that diverse
new biologically and compatible agents with promising success rates are currently
available for paediatric dentistry practitioners. There is no evidence that justifies
discarding the judicious use of DPC procedures in primary teeth.

KEYWORDS
caries exposure, direct pulp capping, primary teeth, pulpotomy, systematic review

1  |   IN T RO D U C T ION American Academy of Pediatric Dentistry (AAPD), DPC

Management of primary teeth with deep carious lesions and
normal pulp or reversible pulpitis continues to be a common
issue in the oral care of young children, and practitioners of
paediatric dentistry should know the most appropriate treat-
ment options for preserving pulp tissue vitality.1,2 Direct
pulp capping (DPC) is a conservative treatment option for
inflamed pulp in its reversible stage.3 According to the
treatment in primary teeth is a procedure indicated follow-
ing a small mechanical exposure (1 mm or less) of normal—
or slightly inflamed pulp—during cavity preparation or
traumatic injury, when conditions for a favourable response
are optimal.4 This procedure consists of the placement of a
medicated material on the exposed pulp in order to obtain
a fluid-tight seal on the pulpal wound for preventing bacte-
rial and toxin microleakage, and also to encourage the pulp

© 2020 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Int J Paediatr Dent. 2020;00:1–11.  |

wileyonlinelibrary.com/journal/ipd     1
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2       GARROCHO-RANGEL et al.
healing through cellular reorganization and the formation
of a reparative ‘dentine-like’ bridge over the exposure site,
with preservation of pulp vitality and integrity.5-7 Finally, a
restoration is placed to seal the tooth hermetically. The use
of DPC is, however, more limited in primary teeth when
compared to immature or mature permanent teeth,8 and has
shown to be less successful than pulpotomy.9,10
Although it is an inexpensive and relatively simple proce-
dure, DPC in primary teeth has been considered highly con-
troversial and intriguing for several years; thus, it is not yet
extensively accepted by clinicians worldwide. In this regard,
the AAPD has emphatically stated that the DPC of carious
pulp exposure in a primary tooth is not recommended due to
its limited application4; likewise, Sujlana et al11 mentioned
that this therapeutic modality ‘has been literally abolished
from the repertoire of therapeutic procedures for primary
teeth’. Five principal reasons have been stated in the literature
for not recommending DPC in primary teeth: (a) the asso-
ciated unsatisfactory success rates and informed poor prog-
nosis; (b) the histological characteristics of the primary pulp
tissue and its peculiar response to irritation and infection,
which may ultimately lead to treatment failure; (c) the re-
ported risk of internal root resorption, possibly related to the
primary pulp's high cellular content—mainly mesenchymal
cells—that, under irritating conditions, tends to differentiate
into odontoclasts; (d) it is frequent that exposure of tooth axial
walls offers a very poor prognosis, in that the coronal pulp
tissue is deprived of its blood supply and undergoes necrosis;
and (e) diverse studies have informed of the development of
pulp inflammation, calcifications, loss of periapical bone, and
acute dentoalveolar abscesses following the procedure.5,9,11-16
Some authors consider that DPC in primary teeth with
carious pulp exposure surrounded by normal dentine appears
to ensure successful outcomes due to the recognized healing
ability of primary pulp cells without the need for more radical
or invasive therapies (eg, pulpotomy).10,14,17,18 According to
these studies, the procedure should be carried out only in very
strictly selected clinical situations, after careful clinical and ra-
diographic examinations to confirm pulp-inflammation revers-
ibility, using rigid and specific diagnostic criteria and treatment
methods with proved dressing materials5,19; some other studies
recommend this treatment only in cases of expected physio-
logical exfoliation of the affected tooth in the next one or two
years.20,21 On the other hand, new and improved biocompatible
and bioactive DPC agents for primary dentition, with remark-
able physical properties, have been recently evaluated.22 Some
of these emerging biomaterials possess enhanced biological
properties for cell stimulation of the primary pulp/dentine com-
plex to induce repair and regeneration, with low toxicity and no
systemic adverse effects.2 They are the materials of choice that
are currently available as appropriate alternatives to traditional
DPC dressers, such as calcium hydroxide, considered the ‘gold
standard’ in this type of pulp treatment.11,23 For all of these
Why this paper is important to paediatric
dentists
• Diverse biological and compatible agents can be
used in DPC procedures in primary teeth, with
promising success rates.
• The need must be highlighted for further confirm-
atory, good quality, and well-reported randomized
controlled clinical trials that involve a long-term
clinical assessment of novel alternative biomateri-
als as DPC agents on primary teeth, before abso-
lutely rejecting this conservative pulp therapy.
• More high-quality clinical studies are definitely
needed, with proper monitoring and following the
appropriate parameters of a clinical trial, such as
those suggested by the CONSORT guidelines.
reasons, DPC in vital primary teeth should not be fully disre-
garded as a pulp therapeutic option.
The aim of the present systematic review of clinical stud-
ies was to address the question regarding the clinical and
radiographic success of the DPC procedure in vital primary
teeth with either non-cariously exposure or small carious ex-
posure of the pulp tissue.
2  |  M ATERIAL S AND M ETHOD S
The present systematic review was carried out according to
the principles of the PRISMA (Preferred Reporting Items for
Systematic Reviews and Meta-Analysis) statement.24 In order
to address and outline the search strategies, the following fo-
cused question was structured: What is the clinical/radiographic
success of the different direct pulp-capping agents used in vital
primary teeth with cariously and non-cariously exposed pulp?
2.1  |  Protocol and registration
This systematic review was registered at the International
Prospective Register of Systematic Reviews (PROSPERO)
under protocol ID CRD42018107700.
2.2  |  Literature search strategies
Five electronic databases were explored (PubMed, Embase,
the Cochrane Library, Dentistry and Oral Science Source,
and Google Scholar) to maximize the identification of
relevant primary studies published over the last 30  years
(January 1988 to December 2019). During the initial search,
GARROCHO-RANGEL et al.
the following MeSH and keywords were employed: “di-
rect pulp capping” AND (“primary OR deciduous” teeth),
with the limitation of only human randomized clinical trials
(RCTs) written in the English language. This search used
a combination of controlled vocabulary and text words as
follows:
(direct[All Fields] AND ("dental pulp cap-
ping"[MeSH Terms] OR ("dental"[All Fields]
AND "pulp"[All Fields] AND "capping"[All
Fields]) OR "dental pulp capping"[All Fields]
OR ("pulp"[All Fields] AND "capping"[All
Fields]) OR "pulp capping"[All Fields])) AND
(primary[All Fields] OR deciduous[All Fields])
AND ("tooth"[MeSH Terms] OR "tooth"[All
Fields] OR "teeth"[All Fields]).
Titles and abstracts were screened independently by two au-
thors (VE-V and AG-R) to identify potential articles that clearly
met the inclusion criteria. After removing duplicates, all finally
selected articles were retrieved in full-text form. An additional
hand search was performed on the reference lists of these in-
cluded studies. When necessary, the corresponding authors
were contacted to obtain additional information on unclear or
missing data. Disagreements were resolved by consensus.
2.3  |  Inclusion criteria
Articles were included in the systematic review if they met
the following criteria:
F I G U R E 1   PRISMA flow chart for
the literature research
  
|
   3
1. Only comparative randomized controlled clinical tri-
als in the English language, comparing different DPC
techniques/agents on primary teeth. Grey literature was
excluded.
2. The DPC procedure was performed in vivo on human vital
(including reversible pulpitis) primary teeth with either
carious or non-carious pulp exposure.
3. A clear evaluation of treatment outcomes (overall success)
was based on both clinical (absence of spontaneous pain,
sinus tract or fistula, soft tissue swelling, and abnormal
mobility) and radiographic (absence of internal/external,
furcal, or periapical radiolucencies, and widening of the
periodontal space) evaluations.
4. Six months of follow-up at least.
2.4  |  Data extraction and quality
assessment of selected studies
The necessary available information was extracted from
each initially included article, through a standardized and
pre-piloted form. This information included the first author's
name, year of publication, country, inclusion criteria, sam-
ple size, tooth type, applied DPC agents, follow-up length
and dropouts, and the statistical significance of success rates.
Evidence tables were then constructed.
Each relevant article was independently and critically eval-
uated by two authors (AG-R and AP-G) for its methodological
research quality (potential risk of bias); these reviewers were
previously calibrated for inter-examiner agreement (Cohen's
kappa = 0.93). Any discrepancy was resolved by discussion
 |
4       GARROCHO-RANGEL et al.

T A B L E 1   Detailed descriptive information from included studies

N and participant age/tooth type/final restoration Initial sample

Study material DPC agents size (teeth)
Demir & Çehreli28 a  100 primary molars from 67 five- to nine-year-old CH cement (Dycal) 20
patients. Molars restored with a composite material Acetone-based single total-etch 20
(Dyract AP®) adhesive (Prime&Bond NT)
Non-rinse conditioner (NCR) + 20
(Prime&Bond NT)
Total-etching (DeTrey 20
Conditioner) + (Prime&Bond NT)
Self-adhesive system (Xeno III) 20
23
Tuna & Ölmez 50 primary molars from 25 five- to eight-year-old CH cement (Dycal) 25
patients. Molars restored with a composite material MTA (ProRoot) 25
(Dyract AP®)
Garrocho et al14 90 primary molars from 45 five- to eight-year-old CH cement (Dycal) 45
patients EMD (Emdogain) 45
10
Aminabadi et al 120 primary molars from 84 four- to five-year-old Calcium hydroxide powder 60
patients. Molars restored with ZOE and steel metal 20% Buckley´s formocresol solution 60
crowns
Fallahinejad-Ghajari et al8 42 primary molars from 21 five- to eight-year-old MTA (ProRoot) 21
patients. Molars restored with amalgam Calcium-enriched mixture cement 21
(CEM)
Aminabadi et al29 b  Primary molars from 54 seven- to nine-year-old Calcium hydroxide powder NR
patients. Molars restored with ZOE and steel metal (Darmstadt)
crowns Simvastatin 1 µmol/L NR
Simvastatin 5 µmol/L NR
Simvastatin 10 µmol/L NR
Fallahinejad et al18 42 primary molars from 21 five- to eight-year-old MTA (ProRoot) 21
patients. Molars restored with amalgam Calcium-enriched mixture cement 21
(CEM)
Ulusoy et al30 40 primary molars from 40 five- to nine-year-old CH cement (Dycal) 20
patients. Molars restored with glass-ionomer base and Calcium sulphate (Dentogen) 20
amalgam
Aminabadi et al6 160 primary molars from 83 five- to nine-year-old Simvastatin 40
patients. Molars restored with glass-ionomer base and 3Mix (ciprofloxacin, metronidazole, 40
amalgam and cefixime)
3Mixtatin (3Mix + Simvastatin) 40
MTA (ProRoot) 40
22
Songsiripradubboon et al 47 primary molars from 42 seven- to eleven- year-old CH cement (Dycal) 23
children. Molars were restored with glass-ionomer Acemannan (aloe vera) 24
and amalgam
Erfanparas et al32 92 primary molars from 46 five- to seven-year-old MTA (ProRoot) 46
patients. Molars were restored with amalgam Resin-modified calcium silicate 46
(TheraCal LC)
Vafaei et al31 90 primary molars from 45 five- to seven-year-old MTA (ProRoot) 45
children, restored with glass-ionomer and amalgam Calcium silicate (Protooth) 45
Note: NR, not reported. Relevant comments.
a
NRC and DeTrey conditioners had no contact with the exposed pulp.
b
The evaluation was only histological (the teeth were extracted after 6-9 months).
GARROCHO-RANGEL et al.   
   5
|

Clinical
Final sample size success rates Radiographic Follow-up Pulp-exposed Type of pulp exposure
Dropout (n) (teeth) (%) success rates (%) period (mo) size (mm) (carious or non-carious)
6 14 100 100 24 <1.0 Carious
3 17 100 100

0 14 100 90

3 17 90 75

1 19 95 95
5 20 100 100 24 <1.0 mm Carious
3 22 100 100

0 45 100 100 12 1.0 Non-carious

0 45 93.33 100
NR 60 61.7 53.3 24 NR Carious
NR 60 90 85

2 19 90.47 100 6 <1.0 Carious

2 19 85.7 100

NR 22 NR NR 6-9 NR Non-carious

NR 30 NR NR
NR 28 NR NR
NR 24 NR NR
2 19 95 NR 20 <1.0 Carious
2 18 81 NR

2 18 83.3 83.3 12 ~1.0 Carious and non-carious

3 17 70.58 70.58

12 28 57.1 100 12 <1.0 Non-Carious

8 32 62.5 100

3 37 91.9 100
8 32 93.8 100
3 20 70 70 6 NR Carious
2 22 72.72 72.72

9 37 94.6 94.6 12 <1.0 Carious

9 37 91.9 91.9

4 41 90.2 90.2 12 <1.0 Carious

4 41 85.4 85.4
 6      
| GARROCHO-RANGEL et al.

and consensus with a third author (VE-V). These processes

followed the statements and criteria established, which in-

Moderate

Moderate

Moderate
Bias risk
cluded these questions: (a) Does the study ask a clearly fo-

Low

Low
Low

Low
Low
Low

Low
Low
Low
cused question?; (b) Was the study a randomized controlled
trial (RCT)? (this question was eliminated from the assess-
ment); (c) Was the method of randomization appropriate?;
of statistical
Description

(d) Was the study described as blind or masked?; (e) Was

analysis

there a clear description of the inclusion and exclusion cri-

Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
teria?; (f) Was there a description of any subject withdraw-
als and dropouts?; (g) Was the method used to assess success
calculation

or failure described?; (h) Was the sample size justified (eg,

study power calculation)?; and (i) Was the method used in
Power

the statistical analysis described? Each item scored 1 point

N
N
Y
N
N
Y
N
Y
N
Y
Y
Y
if the corresponding criterion was satisfied. Thus, an overall
risk-of-bias score was obtained for a single article as follows:
Outcomes (success/

high risk (1-3 points); moderate risk (4-6 points), and low risk
(7-9 points).25,26 Additionally, the same reviewers employed
a second-quality assessment scale in which nine items (sam-
failure)

ple-size calculation, randomization, technique of randomiza-

Y
Y
Y
Y
Y
Y
Y
Y
N
Y
Y
Y

tion, blinding, follow-up, type of response variable, agreement

of the measurement method, assumptions of the statistical
Dropouts

analysis, and results) were scored (0-2 points) and an overall

total was obtained for each selected study. According to the
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y

total value, the risk of bias of the study was graded as follows:
high risk = 0-5 points; moderate risk = 6-12 points; and low
Inclusion/exclusion
T A B L E 2   Methodological quality (risk of bias) assess of selected studies according to Jadad's method

risk = 13-18 points.27
criteria

3  |  RESULTS
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y

3.1  |  Study selection

Blindness

The PRISMA flow diagram of the article selection process is

Y
Y
Y
Y
Y
Y
Y
Y
N
Y
Y
Y

depicted in Figure 1. After screening titles/abstracts and remov-

ing duplicates, the electronic and hand searches identified 83
randomization

potentially relevant studies; 64 were subsequently excluded due

Appropriate

Note: Y, item mentioned in the article; N, item not mentioned in the article.

to diverse reasons, and 19 satisfied the inclusion criteria and

appeared to be relevant; the latter were retrieved in full text for
more detailed information and quality assessment. Finally, 12
Y
N
Y
Y
N
Y
Y
Y
Y
Y
N
N

of these studies were included in the present systematic review.

Clearly focused
question

3.2  |  Characteristics of the included studies

Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y

The corresponding characteristics of the 12 selected stud-

ies are presented in Table 1. These studies were published
22
8
Fallahinejad-Ghajari et al

Songsiripradubboon et al

between 2007 and 2019 and were conducted in departments

of paediatric dentistry at universities or hospital centres.
18
28

Erfanparast et al32
Aminabadi et al10

Aminabadi et al29
Fallahinejad et al
Demir & Çehreli

Aminabadi et al6

According to the type of RCT chosen, four trials were two-

23

14
Tuna & Ölmez
Garrocho et al

30

31

arm studies, two trials employed four-arm comparisons,

Ulusoy et al

Vafaei et al
Reference

one trial was a five-arm study, and five followed the split-
mouth design. Follow-up times ranged from 6  months to
2  years, and dropout rates were <20%. The DPC agents
GARROCHO-RANGEL et al.
tested and compared in these studies were calcium hydrox-
ide (Dycal),14,23,28 formocresol,10 MTA (mineral trioxide
aggregate),8 calcium-enriched mixture,18 simvastatin,29
3Mix (a combination of metronidazole, minocycline, and
ciprofloxacin), 3Mixtatin (3Mix plus simvastatin),6 calcium
sulphate hemihydrate (Dentogen),30 enamel matrix deriva-
tive (Emdogain),14 etch adhesive (Prime&Bond NT), non-
rinse conditioner plus Prime&Bond NT, 36% phosphoric
acid plus Prime&Bond NT, a self-adhesive system (Xeno
III),28 calcium silicate cement (Protooth),31 resin-modified
calcium silicate (TheraCal LC),32 and an extract from aloe
vera (acemannan).22 In general, treated teeth were finally
restored with amalgam, glass-ionomer, or preformed stain-
less-steel crowns. Overall, clinical and radiographic success
rates among the selected studies ranged between 53% (cal-
cium hydroxide) and 100% (MTA and calcium hydroxide).
3.3  |  Risk-of-bias assessment
The risk-of-bias evaluations for the selected studies are
shown in Tables  2 and 3. Globally, both methods pro-
vided similar results and the included articles were graded
as exhibiting low or moderate risk of bias. For instance,
the research-focused question was invariably mentioned.
Randomization methods were always described, but, in
some cases, the generation of random sequence/allocation
concealment was either unclear or inappropriate, and opera-
tor blindness was adequate in the majority of the studies;
however, one study did not report this issue.6 Other items
that received poor scores were those corresponding to the
study power calculation and the agreement of the measure-
ment method. One randomized clinical trial only reported
the histological findings among the compared four inter-
vention arms; clinical/radiographic success rates were not
mentioned.29
4  |   D IS C U SSION
The main goal of pulp therapy in primary dentition is to pre-
serve the vitality of the affected tooth while causing as little
trauma as possible to the pulp tissue.2,9 When a carious primary
tooth remains untreated or inadequately treated, the subsequent
bacterial invasion of the pulp will produce an inflammatory
response, initially confined to the coronal pulp. If the exposed
pulp is dressed and the affected tooth is adequately restored,
the remaining tissue has the ability to recover. An accurate
diagnosis of the presence and extent of pulpal inflammation
or pathosis in primary molars is, however, difficult but essen-
tial to the success of treatment. Thus, preserving the vitality
or healing capacity of the primary tooth pulp can be effective
only if the pulp status is assessed correctly.30,33
  
|
   7
This systematic review aimed to update (up to December
2019) the global evidence on DPC clinical/radiographic
outcomes, when the procedure is indicated and applied in
deeply carious primary teeth; thus, we pretend to contribute
even more to the already-published information provided
by two previous relevant studies carried out by Coll et al34
and Smaïl-Faugeron et al2 on the same topic, collected from
RCTs published up to September 2016 and August 2017,
respectively. In general, our findings are in agreement with
these systematic reviews. There are, however, some sub-
tle methodological differences between these studies and
the present one. For instance, the objectives of these two
reviews were broader; namely, they assessed the available
pulp therapies for cariously involved vital/non-vital pri-
mary teeth: indirect pulp therapy, direct pulp capping, pul-
potomy, and pulpectomy, whereas we focused specifically
on DPC treatment only. Further, they performed diverse
meta-analyses for the data synthesis of several compari-
sons done in their systematic reviews. On the other hand,
Coll et al34 included RCTs with a minimum follow-up of
12 months (we included data from 6-month observations)
and did not include studies on pulp treatments for non-cari-
ous pulp exposures. In addition, they evaluated the possible
effects of related treatment factors (eg, method of isolation,
type of final restoration, and the number of appointments
to treat) on the individual studies’ outcomes.
According to Coll et al,34 there are currently three avail-
able vital pulp therapies for primary teeth with deep caries
approximating the pulp tissue, including the DPC procedure.
Several studies have been carried out to determine the suc-
cess of this controversial treatment. Although the report-
ing quality of clinical studies has improved during the last
years, it remains difficult to standardize the methodology in
pulp-therapy research for primary teeth, because studies may
vary widely regarding the selected design, operative tech-
niques, diagnostic procedures, and the materials employed.19
Published articles on DPC in primary dentition are not an
exception.2 The present review evaluated the most import-
ant published RCTs in the last 30 years in order to evaluate
the medium- and long-term clinical/radiographic efficacy of
agents applied directly on the cariously or non-cariously ex-
posed pulp tissue in vital primary teeth. The great scarcity
of published relevant studies during the last three decades
on this topic was notorious. A total of 12 studies were in-
cluded in the present systematic review, and, due to the sig-
nificant methodology heterogeneity observed among them,
a meta-analysis could not be performed. Although one study
focused solely on comparing histological outcomes, without
reporting clinical and radiographic success rates,29 it was de-
cided to include it in the present systematic review because
we considered that histological and clinical/radiographic re-
sults are strongly correlated; thus, the respective DPC suc-
cess rates could be supposed.
 |
8       GARROCHO-RANGEL et al.

T A B L E 3   Methodological quality appraisal of selected studies through Pozos's scale27

Randomization
Sample calculation Randomization method Blinding
1 = Unspecified/pilot 0 = Not present 0 = Unsuitable/ 0 = Not described
RCT study 1 = Not clear not described 1 = Not clear/inappropriate
Study design 2 = Present 2 = Present 1 = Adequate 2 = Present and described
Demir and Çehreli28 NR 1 1 0 1
23
Tuna and Ölmez NR 1 1 0 2
Garrocho et al14 SM 2 2 1 2
10
Aminabadi et al NR 1 2 0 1
Fallahinejad-Ghajari NR 1 1 0 2
et al8
Aminabadi et al29 NR 2 2 1 2
Fallahinejad et al18 SM 1 2 0 2
30
Ulusoy et al NR 2 2 0 2
6
Aminabadi et al NR 1 2 0 0
Songsiripradubboon NR 2 2 0 2
et al22
Erfanparast et al32 SM 2 2 0 2
Vafaei et al31 SM 2 2 0 2
Abbreviations: H, high; L, low; M, moderate; NR, not reported; SM, split-mouth design.

It was also remarkable to note the interest shown by re-
searches in terms of testing relatively new bioactive and com-
patible materials for DPC in primary teeth, in an attempt to
explore and find suitable alternatives to calcium hydroxide,
traditionally considered the reference dressing material in
this therapeutic modality.5,11 In this regard, 7 of the 10 clini-
cal trials selected for the present systematic review used cal-
cium hydroxide as control material during their execution:
versus resin adhesives, etching systems, or conditioners28;
versus MTA23; vs Emdogain14; vs formocresol10; vs simvas-
tatin29; versus calcium sulphate30; and vs acemannan.22 In
these studies, the global success rates of calcium hydroxide
varied widely, from 53%—when Ca(OH)2 powder was em-
ployed—to 100%—when Dycal was placed; when Dycal was
the control material of choice, the global success rate of DPC
was 70%-100%, with follow-up periods of up to 24 months.
These long-term findings can suggest the non-inferiority of
DPC in terms of clinical and radiographic success rates, re-
garding the pulpotomy procedure for treating deep carious
lesions in vital primary teeth, as long as a careful diagnosis of
the pulp tissue condition is performed; additionally, DPC is a
more conservative and time-saving treatment, involving less
discomfort for children than pulpotomy. On the other hand,
other authors have stated that calcium hydroxide has demon-
strated diverse disadvantages as a pulp-capping dresser;
thus, its long-term efficacy has been questioned as follows:
first, its failure to bond to dentine; second, it tends to cause
pulp-surface inflammation/necrosis and internal root resorp-
tion; third, its slow stimulation of dentine bridge formation,
and fourth, the morphological microstructure of this dentine
bridge is quite permissive, due to an evident amount of tunnel
defects.35,36 All of these reasons facilitate the microleakage
of pulpal fluids, dissolution of calcium hydroxide, and bacte-
rial invasion, which may lead to treatment failure.11
According to the findings extracted from the included
studies, several of the assessed regenerative materials of
recent introduction has demonstrated promising potential
for DPC treatment in primary teeth; additionally, the corre-
sponding success rates of these agents depend on the char-
acteristics of the material itself (eg, antimicrobial properties,
low/null cytotoxicity, or preservation of pulp tissue integrity)
and its biocompatibility with the primary pulp tissue.29,36 For
instance, mineral trioxide aggregate (MTA), which was clin-
ically and histologically tested in four studies,6,8,18,23 exhib-
ited high success rates, ranging from 90% to 100%. These
data reveal that MTA can be a recommendable DPC material
for primary teeth due to its stimulation capacity for the heal-
ing of pulp and bone/periodontal tissues, and its adequate
sealing ability.31,32,36,37 This material has, however, several
drawbacks: it is much more expensive than other pulp dress-
ers; it is difficult to manipulate; it involves a very long set-
ting time (more than 2  hours) and entertains the potential
of tooth discoloration.38 Other relevant materials included
a calcium-enriched mixture,8 with a reported success rate
GARROCHO-RANGEL et al.   
   9
|

Response Assumptions of the

variable statistical analysis
Follow-up 0 = Qualitative/ Concordance of the 0 = Not present
0 = Incomplete subjective measurement method 1 = Not clear/categorical
1 = Intention to treat/ 1 = Qualitative/ 0 = Not present data Results
other analysis methods objective 1 = Not clear 2 = Present and 0 = Incomplete
2 = Full 2 = Quantitative 2 = Present described 1 = Complete Total/bias risk
1 1 0 1 1 7/M
1 1 0 1 0 7/M
2 1 2 1 1 14/L
1 1 2 1 1 10/M
1 1 0 1 1 8/M

1 1
1 1
1 1
1 1
1 1
2 1 1 13/L
0 1 1 9/M
0 1 1 10/M
0 1 1 7/M
2 1 1 12/M

1 1 2 1 1 12/M
1 1 2 1 1 12/M

of between 85% and 100%; this is considered an excellent
alternative to calcium hydroxide and MTA, due to its mul-
tiple advantages, such as hard-tissue/hydroxyapatite forma-
tion, antibacterial activity, sealing ability, and quick setting
time.39 When MTA and the calcium-enriched mixture were
compared,8 both materials exhibited similar high clinical and
radiographic efficacies over 9 months of follow-up.
Using bonding systems as pulp-capping materials in
primary teeth remains very controversial.28 Some authors
support the employment of these adhesive materials as a
biologically safe procedure. This statement is based on the
proved hermetic re-seal over the pulp wound and the for-
mation of a hybrid layer that permits an intimate adhesion
between the resin and the dentino-pulpal complex; as a con-
sequence, the penetration of bacterial/toxins and pulp fluids
is prevented.40 This information was confirmed through the
findings from Demir et al,28 a study included in the present
review. These authors reported high DPC success rates (75%-
100%) after 2 years of follow-up, using four different etching/
conditioner/adhesive systems; however, their results should
be taken with caution, particularly in terms of application
in class II cavities with exposed pulp. Conversely, other in-
vestigators have dissuaded the employment of these systems
as DPC agents because of the direct histological toxicity of
the individual components (mainly monomers) in the adhe-
sive resins, their proneness to shrinkage, the lack of dentine
bridge formation, the promotion of haemorrhage, and the
subsequent inflammatory response, which significantly com-
promise the pulp-healing process.41,42
In addition to a careful initial diagnosis of pulp status, di-
verse authors have emitted some clinical considerations to be
taken into account that may enhance the prognosis for DPC
success in primary teeth: (a) thoroughly remove peripheral
masses of soft carious dentine prior to when the exposure will
probably occur, to avoid the penetration of necrotic and infected
dentine chips; (b) use non-irritating solutions, and (c) enlarge
the exposure site to 1 mm before the placement of the capping
material in order to remove the surface inflamed/infected pulp
tissue, to facilitate the washing away of debris, and to allow a
closer contact between the material and the pulp tissue.5 An
additional factor that may exert an influence on the reported
medium- and long-term success rates of DPC is the final res-
toration type selected to place over the treated primary tooth.
It has been demonstrated by diverse clinical trials and system-
atic reviews5,43-45 that the immediate placement of a preformed
stainless-steel crown significantly increases the success of the
pulp treatment of decayed primary teeth, due to the crown's
excellent full-coverage protection and hermetic seal. In sum-
mary, DPC success in primary teeth is closely associated with
two principal factors: the maintenance of healthy pulp tissue at
the exposure site, and the absence of microbial contamination
due to microleakage under the restoration.46
In addition to the possibility of missing relevant studies, the
present systematic review exhibits some other limitations. The
 |
10       GARROCHO-RANGEL et al.
most important issue was that we pretended to announce the
most recent evidence on DPC clinical/radiographic outcomes
in primary teeth; however, we did not differentiate whether the
pulp exposure was carious or non-carious. Thus, the combined
findings taken together and reported in the present systematic
review could influence the recommendation of using the DPC
in primary teeth because inflammation is usually not present in
the coronal pulp of non-carious pulp-exposed teeth, unlike the
carious exposures, in which the extent of pulpal inflammation
is greater. In the second place, several included studies did not
fully describe the employed methods for randomization, assigna-
tion concealment, sample-size calculation, blinding, and patient
dropout control and its corresponding statistical management;
however, operator blinding is nearly impossible in many clinical
trials because the appearance and handling features among ma-
terials are dissimilar. Follow-up period lengths were quite differ-
ent among studies, which may explain the reported wide success
rate range. All of these aspects may compromise the reliability
and validity of any RCT comparing interventions.2,36 Finally, we
included results of studies with post-operative observation peri-
ods of only six months; Coll et al34 have stated that this may be
an insufficient time to determine with certainty the success or
failure of a vital pulp treatment in the primary dentition.
5  |   CO NC LU SION S
Based on this systematic review, and within its limitations, we
can conclude that evidence for the superiority of any material
for DPC in primary teeth, in order to preserve the pulp health,
was not found. According to the obtained information, and al-
though the proportion of clinical and radiographic failures was
low, there is no support to strongly recommend a particular
agent over another for DPC in the primary dentition. It appears
that calcium hydroxide and adhesive systems, however, demon-
strate a higher probability of failure, and formocresol exhibits di-
verse safety/toxicity/carcinogenicity concerns. Therefore, other
safer and more biocompatible agents, such as MTA, calcium-
enriched mixture, Emdogain, calcium sulphate, and simvasta-
tin, could be better options for this pulp therapy. Additionally,
clinicians need to know that other potentially successful newer
biological materials for DPC treatment, such as bioceramics, are
currently being tested for promoting the regenerative capability
of the pulpo-dentinal complex in primary and immature perma-
nent teeth. These biomaterials will be, however, commercially
available in the near future, until having enough relevant and
reliable collected evidence.
ACKNOWLEDGEMENTS
The review of this manuscript by Maggie Brunner has been
particularly appreciated. This study was partially supported
by PFCE-UASLP grant.
CONFLICTS OF INTEREST
The authors manifest no perceived conflict of interest.
AUTHOR CONTRIBUTIONS
AGR and APG conceived the idea. AGR and VEV collected
the data. AGR, APG, and VEV analysed the data. AGR,
APG, and VEV led the writing.
ORCID
Arturo Garrocho-Rangel  https://orcid.
org/0000-0001-9123-0300
Amaury Pozos-Guillen  https://orcid.
org/0000-0003-2314-8465
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How to cite this article: Garrocho-Rangel A,
Esparza-Villalpando V, Pozos-Guillen A. Outcomes
of direct pulp capping in vital primary teeth with
cariously and non-cariously exposed pulp: A
systematic review. Int J Paediatr Dent. 2020;00:1–11.
https://doi.org/10.1111/ipd.12633