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PEDIATRIC DENTISTRY V 39 I NO 1 JAN / FEB 17

Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis


James A. Coll, DMD, MS' • N. Sue Seale, DDS, MSD3 • Kaaren Vargas, DDS, PhD3 • Abdullah A. Marghalani, BDS, MSD, DrPH4 • Shahad Al Shamali, BDM5
Laurel Graham, MLS6

Abstract: Purpose: This systematic review and meta-analysis assessed outcomes in prim ary teeth fo r the vital pulp therapy (VPT) options o f
indirect pulp therapy (IPT), direct pulp capping (DPC), and pulpotom y after a m inim um o f 12 m onths to determine whether one VPT was su­
perior. Methods: The following databases were searched from I960 to September 2016: MEDLINE, EMBASE, CENTRAL, EBSCO, ICTRP, Dissertation
abstracts, and grey literature fo r parallel and split-mouth randomized controlled trials o f at least 12 months durotion comparing the success o f
IPT, DPC, and pulpotom y in children with deep caries in prim ary teeth. Our prim ary outcome measure was overall success (combined clinical
and radiographic). Three authors determined the included RCTs, perform ed data extraction, and assessed the risk o f bias (ROB). Meta-analysis
and assignment o f quality o f evidence by Grading o f Recommendations Assessment, Development and Evaluation approach were done. Results:
Forty-one articles qualified fo r meta-analysis (six IPT, fo u r DPC, and 31 pulpotom y) from 322 screened articles. The 24-m onth success rates
were: IPT=94.4 percent, and the liner m aterial (calcium hydroxide [CH]/bonding agents) had no effect on success (P=0.88), based on a moderate
quality o f evidence; DP = 88.8 percent, and the capping agent (CH/alternate agent) did not affect success (P=0.56), based on a low quality o f
evidence. The combined success rate fo r all pulpotomies was 82.6 percent based on 1,022 teeth. Mineral trioxide aggregate (MTA) (89.6 percent)
and formocresol (EC) (85.0 percent) success rates were the highest o f all pulpotom y types and were n o t significantly different (P=0.15), with
a high quality o f evidence. MTA’s success rate (92.2 percent) was higher than ferric sulfate (FS) (793 percent) and approached significance
(P=0.06), while FS’s success rate (84.8 percent) was not significantly different from FC (87.1 percent), both with a moderate quality o f evidence.
MTA and FC success rates were significantly better than CH (P=0.0001), with a moderate quality o f evidence. A t 18 months, sodium hypochlorite
(NaOCI) success rate was significantly less than FC (P=0.0l) with a low quality o f evidence. Conclusions: The highest level o f success and quality
o f evidence supported IPT and the pulpotom y techniques o f MTA and FC fo r the treatm ent o f deep caries in prim ary teeth after 24-months.
DPC showed similar success rates to IPT and MTA o r FC pulpotomy, b u t the quality o f the evidence was lower. Systematic Review Registration
Number: PROSPERO 2015: CRD42015006942. (Pediatr Dent 2017;39(1):16-27.E15-E95) Received September 28, 2016 I Accepted December 15, 2016

KEYWORDS: PRIMARY TEETH, PULP THERAPY, SYSTEMATIC REVIEW, META-ANALYSIS

Dental caries is the most common chronic disease of child­ ture since the mid 1800’s.4,5 However, a number of studies of
hood.1When caries is untreated it can endanger the vitality of IPT in primary teeth have been published with encouraging
the tooth, causing infection, pain, abscess, and premature tooth results.^10
loss; thus, early intervention is very important for the child’s DPC is a technique in which the pulp is covered with a
overall health and development.2 biocompatible material when caries excavation causes a pin­
Currently, there are three vital pulp therapy (VPT) options point pulp exposure.11 Past reports of DPC in primary teeth
for treatment of deep dental caries approximating the pulp in have shown limited success;12,13therefore, DPC has had lim­
primary teeth (1) indirect pulp treatment (IPT), also known ited acceptance as a technique for management of carious pulp
as indirect pulp cap; (2) direct pulp cap (DPC); and (3) pulpo­ exposures in the primary dentition.
tomy. 2,3 Pulpotomy is a procedure used when the excavation of caries
IPT is a procedure that leaves the deepest caries adjacent in primary teeth produces a carious pulp exposure. In this tech­
to the pulp undisturbed in an effort to avoid a pulp exposure. nique, the entire coronal pulp is removed, hemostasis of the
This caries-affected dentin is covered with a biocompatible radicular pulp is achieved, and the remaining radicular pulp is
material to produce a biological seal.2-’The use of IPT remains treated with one of several different medicaments.2,3 Published
controversial even though it has been described in the litera- studies of this procedure have been reported since the early
1900’s,14 and currently pulpotomy is the most frequently used
VPT technique for deep dental caries in primary teeth.15
‘Dr. Coll is a clinical professor and *Dr. Marghalani is a pediatric dental fellow, Divi­
sion of Pediatric Dentistry, both at the University of Maryland Dental School, Balti­
more, Md., USA. -Or. Seale is a Regents Professor, Department of Pediatric Dentistry, ABBREVIATION KEY.
Texas A&M College of Dentistry, Dallas, Texas, USA. 3Dr. Vargas is in private practice,
Corridor Kids Pediatric Dentistry, North Liberty, Iowa, USA. sDr. Al Shamali is a VPT: Vital pulp therapy. IPT: Indirect pulp treatment. DPC: Direct
Resident in Pediatric Dentistry. Department of Pediatric Dentistry, University of Illinois pulp cap. RCTs: Randomized controlled trials. RR: Relative risks.
at Chicago College of Dentistry; and 6Ms. Graham is Evidence-Based Dentistry Manager, Cl: Confidence intervals. NNT: Number need to treat. ROB: Risk-
American Academy of Pediatric Dentistry, both in Chicago, III., USA. of-bias. GRADE: Grading of Recommendations Assessment, De­
Correspond with Dr. Seale at velopment, and Evaluation. FC: Formocresol. MTA: Mineral trioxide
Supplemental material available aggregate. FS: Ferric sulfate. NaOCL: Sodium hypochlorite. CH:
in the online version. Calcium hydroxide.

16 VITAL PULP THERAPY


P EDIATRIC D E N TIS T R Y V 3 9 I NO 1 JAN I FEB 17

Many studies have been conducted to determine the effi­ The population was defined as healthy pediatric patients
cacy of IPT, DPC, and pulpotomy. Investigations vary in design, who required vital pulp therapy for deep caries in primary teeth
techniques, materials used, and diagnostics for determining including molars, incisors, and canines, and the tooth was our
and reporting outcomes, all of which affect the quality of the unit of analysis. The intervention was any of the three types of
evidence produced.6' 10,12'13-16"18 Therefore, standardization of VPT (IPT, DPC, and pulpotomy of any type), and the compar­
methodology has been critical to analyzing VPT studies; in ison was to any other VPT. Pulpal treatments as a result of
recent years, as the number of randomized controlled clinical non-carious pulp exposures were excluded. Outcomes were
trials (RCTs) conducted and published has increased, reporting reported as overall success, determined as simultaneous clinical
quality has improved. and radiographic success, after a minimum of 12 months. Study
VPT is so frequently used in the management and mainte­ design was limited to RCTs.
nance of the primary dentition that an analysis of the existing Data extraction. Two of the three reviewers (JC, SS, KV)
literature is imperative. Previous systematic reviews and meta­ independently performed the data extraction and risk-of-bias
analyses have compared one or more types of vital pulp ther­ assessment for the included articles using a standardized tem­
apy;19-21 however, none have included all the three vital pulp plate. Forty-nine fields were extracted from each study when
therapy options (IPT, DPC, and pulpotomy) or compared possible (Electronic Appendix: Section la). If there were ques­
medicaments for these treatment options.19-21 tions regarding data, attempts were made to contact the study’s
The purpose of this investigation was to perform a systema­ authors. Disagreements were resolved through discussion by the
tic review and meta-analysis of VPT in cariously involved vital reviewers. For RCTs with more than two arms, only relevant
primary teeth after a minimum of 12 months to determine the arms were considered. RCTs with split-m outh designs were
overall (combined clinical and radiographic) success rates and combined with parallel designs for possible subgroup analysis
whether one VPT was superior. In addition, we evaluated VPT and meta-regression analysis.
moderators/factors that may have had effects on outcomes such Data synthesis. Meta-analysis were done by one author
as method of isolation, type of final restoration, and number (AAM) using systematic review software programs Review
of appointments to treat. Manager (RevMan) Version 5.2.1 and Comprehensive Meta-
Analysis (CMA) 3.0 software (Biostat, Englewood, N.J., USA).
Methods We used the random effects models, inverse variance method,
In order to enhance the transparency, a protocol was published22 to obtain pooled relative risks (RR) and 95 percent confidence
and is available on open access at: “http://www.ingentaconnect. intervals (Cl) for overall success. The number needed to treat
com/content/aapd/pd/2015/00000037/00000005/art00002”. (NNT) for each outcome was determined by reciprocating the
Search strategy. One of the authors (LG) searched the pooled risk difference. We reported the overall success as a per­
following databases from 1960 to September, 2016: MEDLINE centage with 95% Cl by combining success proportions in
(PubM ed) 1960; EMBASE; Cochrane C entral Register of each and both comparison groups, provided there was no signi­
Controlled Trials (CENTRAL); EBSCO— Dentistry and Oral ficant difference between the two groups, using random-effect
Sciences Source; IC TR P (trials database); Dissertation ab­ models considering within and between-trials variance. The
stracts; and the grey literature. The search used MeSH terms heterogeneity was determined by using the I2 statistic and the
and keywords to find both published and unpublished studies. Cochrane test for heterogeneity, with P less than 0.1 considered
Note that there is not a MeSH term for indirect pulp therapy; to be statistically significant. We assessed publication bias if
the phrase pulp therapy was used to retrieve IPT studies. We the number of included RCTs exceeded 10. We conducted
searched relevant journals from 1990 onward, since that date sensitivity analysis by including high risk of bias or industry
was the earliest we expected to find RCTs. See Electronic Ap­ funded trials in the meta-analyses.
pendix: Section 1 for search strategy and a list of journals in­ Outcomes. Primary Outcomes. We defined overall success
dividually searched. We also used an objective search strategy, as only those teeth that showed both clinical (absence of spon­
which is a variation of the method listed in Routine Develop­ taneous pain, soft tissue pathology, and pathologic mobility)
ment of Objectively Derived Search Strategies.23 The resulting and radiographic success (absence of internal/external, furca­
search strategy retrieved all vital pulp therapy included studies tion, or periapical radiolucency) simultaneously in studies with
cited by the recent Cochrane pulp therapy review.19 a follow-up of at least 12 months.
Titles and abstracts were screened by three reviewers (JAC, Variation In Primary Outcome Measures. Rules were devel­
NSS, KV) to identify studies for inclusion in the systematic oped to recalculate and standardize outcome data for some
review. A member of the work group provided translations for studies, because determ ination of success and failure varied
Spanish and Portuguese studies. W hen a paper was in a non- according to outcome measurement. Data collection for exfoli­
English language other than Spanish, or Portuguese and needed ated teeth varied among studies. Some studies considered nor­
further review, a translation was requested. mal, uneventfully exfoliated teeth to be dropouts and removed
If a study’s abstract was unclear, the full report was accessed them from the calculations for success.17-24'26 Some studies
to determine eligibility for inclusion. If a study published re­ reported a failure in one time frame but did not carry that
sults for different time frames, data from all of the publications failure forward to the next time fram e.17-24-25 Some studies
were considered for inclusion. All papers were reviewed in du­ reported an overall success separately as various combinations
plicate by the authors (JAC, NSS, KV) to determine inclusion of clinical and radiographic success.6,10,11'13-18-27'31 The remaining
as described in the Selection Criteria. studies rated radiographic success as the overall success. In a
Selection criteria. Inclusion and exclusion criteria were few studies internal root resorption was rated as a success,32'34
based on the population, intervention, comparison, outcomes, and one study did not consider excess mobility of a treated
and study design (PICOS) method. tooth as a failure.25 Studies included in the meta-analysis had
data recalculated when necessary by two authors using these
VPT Standardization Rules (JAC, SAS).

V ITA L PULP TH E R A P Y 17
P E D IA TR IC D E N TIS T R Y V 39 I NO 1 JAN / FEB 17

VPT Standardization Rules. Overall VPT success was stand­ assigned a score of four or six, with six=18 months and four
ardized by applying the following rules: = 12 months. Magnitude o f the effect was determined by the
1. Following a VPT, if a tooth exfoliated in less than six overall success of the medicaments in each arm of the meta­
months, it was counted as a failure. analysis. The overall quality of evidence was assessed for each
2. If a tooth exfoliated greater than six months after VPT, important outcome as high, moderate, low, or very low.
it was always counted as a success in all future time
frames. Results
3. Once a tooth’s VPT failed in a time frame, it was cal­ Description o f studies
culated as a failure in all future time frames. The table describing the characteristics of the 41 studies in­
4. Contained internal resorption and excess mobility were cluded in the meta-analysis is in the Electronic Appendix:
counted as failures in any time frame. Section 3. Initial searches from all sources identified 2,204
5. A drop out in any time frame was removed from that references on pulp therapy in primary teeth, which yielded 926
time frame’s denominator and all future time frames in non-duplicate titles. Abstracts from 322 were reviewed and
calculating success. 148 excluded, because they were non-RCTs or studies of non-
6. Overall success was defined as only those teeth that vital treatment, leaving 174 for full text assessment. Following
showed both clinical and radiographic success simul­ full-text assessment for eligibility, 101 articles were excluded
taneously. with reasons (wrong study design, wrong population, and/
or wrong follow-up) leaving 71 articles for data extraction.
The definition of overall VPT success was revised since Following review, 41 articles were determined to be low or
the protocol was published, and this revised definition was unclear ROB and qualified for inclusion in one or more
used in reporting data. meta-analyses (Figure 1). The 30 not eligible for meta-analysis
Secondary Outcomes. The secondary outcomes of pain, soft included 21 that were determ ined to be unique vital pulp
tissue pathology, pathologic mobility, furcation and periapi­ treatm ent comparisons that could not be compared to any
cal radioluocency, and external/internal root resorption were other study12,18-27,3234'38'51,52-53 (Electronic Appendix: Section 4).
not evaluated, because studies did not describe these o u t­ The 9 that were rated as high bias54'62 (Electronic Appendix:
comes in sufficient detail to allow consistent data extraction Section 3) were used in meta-analysis as part of the sensitivity
among studies. analyses.
Outcome moderators/factors. T he hypothetical outcome The 41 articles in the meta-analysis actually represented
moderators/factors evaluated for their potential significant effect 39 separate studies, because four were two different studies
on success using subgroup and meta-regression analyses in­ reported at two different time intervals.7'5,28 These 39 studies
cluded method of tooth isolation, type of final restoration, ti­ included nine split-mouth designs and 30 parallel-arm designs
ming of final restoration placement, hemostasis method, type with 3,709 randomized primary teeth in 2,078 children ranging
of IPT, DPC, and pulpotomy base material, and calcific meta­
morphosis.
Risk o f bias assessment. The Cochrane Collaboration’s
risk-of-bias assessment tool was used to create an overall assess­
ment of the risk-of-bias (ROB) for each study based on key
domains (Electronic Appendix: Section 2).35 A low ROB was
when all of the key domains of bias were judged to have low
risk. An unclear ROB had at least one key domain judged as
unclear. The high ROB had at least one key domain judged
to have a high risk of bias. Only studies with low and unclear
ROB were used in the meta-analysis presented in this paper.
Grading. The Grading of Recommendations Assessment,
Development, and Evaluation (GRADE) system was used to
judge the quality of evidence of each outcome included in the
meta-analysis.36 The criteria used included ROB/study limit­
ations, consistency of results, precision, importance, and mag­
nitude of the effect. ROB was determined using the Cochrane
Risk of Bias Tool and GRADE guidance on overall ROB. In
the meta-analyses Consistency was judged based on the hetero­
geneity (I2) of the studies in the meta-analysis and assigned
as Not Serious (Low): I2=0-30 percent, Serious (Moderate):
I2=35-65 percent, and Very Serious (High): I2=>75 percent.37
Precision was based on the total sample size in each arm of
the meta-analysis. Sample size imprecision was assigned as
Not Serious (greater than 125 total teeth in each arm), Serious
due to small sample size (65-110 total teeth in each arm),
and Very Serious due to very small sample size (less than 50
total teeth in each arm). Importance was judged as Critical or
Im portant based on length o f follow-up in m onths in the
meta-analysis. Critical was assigned a score of eight or nine
with nine=36 months and eight=24 months; Im portant was Figure 1. Flow chart.

18 V ITA L PULP TH ER APY


PEDIATRIC DENTISTRY V 39 l NO 1 JAN I FEB 17

in age from 2.3 to 12.5 years. Studies included in meta-analysis O f the 41 articles used in the meta-analysis, six were 1PT
by country of origin are reported in the Electronic Appendix: articles comparing different IPT liners’ success rates (Electronic
Section 5. Appendix: Section 6, Table le), four were DPC articles com­
The 71 trials that underwent data extraction were pub­ paring different pulp capping materials’ success rates, (Electro­
lished between 1991 and 2016 with the majority (72 percent) nic Appendix: Section 6, Table 2e) and 31 were pulpotomy
published between 2005 and 2012. They were all single-center articles comparing formocresol (FC), mineral trioxide aggregate
trials except one, which was a multicenter trial.16 These trials (MTA), ferric sulfate (FS), sodium hypochlorite (NaOCL), laser,
were conducted in pediatric dentistry departments of a uni­ calcium hydroxide (CH), and tricalcium silicate (Biodentine)
versity or hospital. All trials were conducted by dentists, success rates. (Electronic Appendix: Section 6, Table 3e).
residents supervised by pediatric dental faculty, or fifth year The ROB assessment table for the 71 included studies
dental students. from which data were extracted is in the Electronic Appen­
dix: Section 7, and only four studies met the criteria to be
classified at low ROB.24,34,63,64

Overall success, low and unclear risk of bias trials, 24 months


Mo CH CH R isk R atio R is k R atio
Study o r S ub g rou p E ven ts T o ta l E ven ts T o ta l W e ig h t IV. R andom , 95% Cl IV, R andom . 95% Cl

Buyukgural et al., 2008 180 180 60 60 97.4% 1.00 [0.98,1.02)


C asag ra n de et al., 2008 14 16 13 15 0.8% 1.01 [ 0 . 7 7 , 1 . 3 2 ) -------------------------------
F a ls te re ta l., 2002 24 25 20 23 1.8% 1.10 [0.9 2,1 .32 ) ---------------------

T o ta l (95% Cl) 221 98 100.0% 1 .0 0 1 0 .9 8 ,1 .0 3 ] i ■


Total events 218 93
H eterogeneity: Tau3 = 0.00; C h P = 1 18. d f = 2 (P = 0 56), Is = 0% I------------------ 1------------------- -----------------------h - H
T e s t for overall e ffe c t Z = 0.15 (P = 0.88)
0.5 0 7 1.5 2
Favors CH Favors N o CH

R D = 0 .0 0 (-0 .0 2 , 0 .0 3 ), N N T = c a n n o t b e c a lc u la te d , n o t s ig n ific a n t.

Figure 2. Forest plot o f IPC success at 24 months.

Overall success, low and unclear risk of bias trials, 24 months *


A lte rn a te CH R isk Ratio R is k R atio
Study o r Subgroup Events T otal Events T otal W e ig h t fV, R andom , 95% a IV, R andom , 95% Cl

A m in ab a di e t al., 2010 51 60 36 60 24 1% 1.42 [1.12,1.79)


D e m ira n d C ehreli, 2007 72 80 20 20 37 5% 0 92 [0 8 3 .1 01)
T u na and O lmez, 2008 22 22 20 20 384% 1 0 0 (0 .9 1 ,1 091

T o ta l (95% Cl) 162 100 100.0% 1.05 [0 .8 9 ,1 .2 5 ]


T o ta l events 145 76
Heterogeneity: Taua = 0.02; C h P r 11 44, d f= 2 (P = 0 003); P = 83% j— ■ H -------------------------------------1—
0.7 1.5 2
T e st fo r overall effect: Z = 0.59 (P = 0.56) 05
Favors C H Favors Alternate

R D = 0 .0 4 (-0 .1 3 , 0 .2 1 ). N N T = 2 5 , n o t s ig n ific a n t

Figure 3. Forest plot o f D PC success at 24 months.

Overall success, low and unclear risk of bias trials, 24 months *


MTA FC R isk Ratio R isk Ratio
Study o r Subgroup Events T otal Events Total W e ig ht IV, Random . 95% a IV. Random . 95% Cl

E rd e m e ta l., 2011 24 25 23 25 163% 1.04 10 9 1.1 .2 0 )


Fernandez et al., 2013 20 20 24 25 23.3% 1.04 [0.92,1.16)
Moretii et al., 2008 14 14 15 15 19 2% 1.00 [0.88.1.14)
N o orollah ia n 2008 17 19 18 18 10.0% 0.90 |0 75.1.08)
S o n m e z e ta l, 2008 10 15 10 13 1.6% 0 87 )0 54, 1.38)
S ub ra m a nlam et al., 2009 19 20 17 20 7.5% 1.1 2 (0 9 1,1 .3 8 )
S ushynskt et al., 2012 58 65 49 66 119% 1 20 11.02,1 42]
Y ild irim et al., 2016 57 63 27 33 10.2% 1.11 (0 92,1 32]

T o ta l (95% Cl) 241 215 100.0% 1 .0 4 (0 .9 8 ,1 .1 1 ]


T otal events 219 183
Heterogeneity: T a u *= 0 00. C h i*= 7 27, d f= 7 (P = 0.40), P = 4% -t- I
T est for overall effect: Z = 1.44 (P = 0.15) 1.5 2
Favors FC Favors MTA

R D = 0 .0 4 (-0 .0 1 , 0 .1 0 ) N N T = 2 5 , n o t s ig n ific a n t

Figure 4. Forest Plot for Pulpotomy Success for Formocresol (FC) versus M ineral Trioxide Aggregate (MTA)
at 24 months.

* CH=Calcium Hydroxide. RD=Risk Difference. N N T=N um ber Needed to Treat. CI=Confidence Interval.
IV, Random=inverse variance random-effect model. df=degrees of freedom.

VITAL PULP THERAPY 19


P E D IA TR IC D EN TIS T R Y V 3 9 / NO 1 JAN I FEB 17

Meta-Analysis Results Comparing Different Pulp Treat­ otomies for all follow-up times (12, 18, and 24, months) are
ment Interventions On Success Outcomes included in Electronic Appendix: Section 10a.
IPT. Six articles6’10,28 compared IPT success using CH liners FC vs. FS pulpotom y (24-months). Four articles com ­
versus bonding agent liners. The 24-month overall success rate paring FC to FS had a follow-up of 24 m onths.17,65'66,68 The
of IPT irrespective of the liner was 94.4 percent (95% Cl: FC overall success rate was 87.1 percent (95% Cl: 78.2, 92.7
84.9, 98.0 percent). The meta-analysis showed the liner had percent), and FS’s was 84.8 percent (95% Cl: 76.2, 90.6 per­
no effect on IPT success (P=0.88) (RR 1.00 95% Cl: 0.98, cent), with the meta-analysis favoring neither agent’s success
1.03) (Figure 2). At 48 months, the overall success rate of IPT (RR 1.02 95% Cl: 0.93, 1.13) (/>=0.65). The quality of the
decreased to 83.4 percent (95% Cl: 72.9 percent, 90.4 per­ evidence for this outcome at 24-months was moderate due to
cent), with the meta-analysis showing no significant difference small sample sizes. Forest plots for FC vs. FS pulpotomies for
between CH or bonding agent/liners (RR 1.10 95% Cl: 0.92, all follow-up times (12, 18, and 24, months) are included in
1.32) (/J=0.31). The quality of the evidence for liners was best Electronic Appendix: Section 10b.
at 24 months, and was assessed as moderate because of small FC vs. CH pulpotom y (24-months). Four articles com ­
sample size issues. At 48-months the quality of evidence was paring FC to C H had a follow-up o f 24 m o n th s.17,33,67,68
assessed as low due to the very small sample size issues. Forest The FC overall success rate was 79.0 percent (95% Cl: 57.7,
plots for IPT for all follow-up times (12, 18, 24, and 48 months) 91.2 percent) and C H ’s was 41.4 percent (95% Cl: 26.5, 58.1
are included in the Electronic Appendix: Section 8, and the percent), with the meta-analysis indicating FC was signifi­
Summary of Findings for IPT are included in the Electronic cantly b etter than C H (RR 1.76 95% C l: 1.40, 2.23)
Appendix: Section 8, Table le. (A><0.001). The N N T of three was significant. The quality of
Direct Pulp Cap. Three o f the four DPC articles com­ the evidence for this outcome at 24-months was moderate due
pared CH versus alternative direct capping agents after 24- to small sample sizes. Forest plots for FC vs. CH pulpoto­
months (dentin bonding agents11, MTA29, and FC31). The mies for all follow-up times (12, 18, and 24 months) are
24-m onth overall success rate of D PC irrespective of the included in Electronic Appendix: Section 10c.
capping agent was 88.8 percent (95% Cl: 73.3, 95.8), and M TA vs. CH pulpotomy (24-months). Three articles com­
the meta-analysis showed the capping agent had no effect on paring MTA to CH had a follow-up of 24 months.67,68,74 The
success (RR 1.05 95% Cl: 0.89, 1.25) CP=0.56). However, the MTA overall success rate was 89.0 percent (95% Cl: 59.6,
quality of the evidence for whether DPC capping agent affected 97.8 percent), and CH was 46.0 percent (95% Cl: 35.0, 57-3
success at 24 months was assessed as very low because of the percent), with the meta-analysis indicating MTA was signifi­
high degree of heterogeneity in the studies (I2= 83%) and small cantly b etter than C H (RR 1.96 95% C l: 1.52, 2.53)
sample size (Figure 3). Forest plots for DPC for all follow-up (TcO.OOOl). The N N T of three was significant. The quality of
times (12, 18, and 24, months) are included in the Electronic the evidence for this outcome at 24-months was moderate due
Appendix: Section 9, and the Summary of Findings for DPC to small sample sizes (Figure 5). Forest plots for MTA vs. CH
are included in the Electronic Appendix: Section 9, Table le. pulpotomies for all follow-up times (12, 18, and 24 months) are
Pulpotomy. When the results were pooled for all 31 pulpo- included in Electronic Appendix: Section lOd.
tomy articles used for the meta-analysis, the overall success FS vs. CH pulpotomy (24-months). Two articles comparing
rate from the MTA, FC, FS, NaOCL, CH, and laser 24-month FS to CH had a follow-up of 24 m onths.17,68 The FS overall
studies was 82.6 percent (95% Cl: 75.8, 87.8 percent ) based success rate was 82.1 percent (95% Cl: 68.2, 90.7 percent), and
on 1,022 teeth. MTA and FC 24-m onth success rates were CH was 52.8 percent (95% Cl: 39.5, 65.8 percent), with the
the highest of all pulpotom y types in this time frame and meta-analysis indicating FS was significantly better than CH.
were not significantly different (/>=0.15). MTA’s success rate (RR 1.57 95% Cl: 1.19, 2.06) (/Ml.OOl). The N N T of four was
was 89.6 percent (95% Cl: 82.5, 94.0), and FC’s was 85.0 significant. The quality of the evidence for this outcome at 24-
percent (95% Cl: 76.3, 91.0). At 24 months, MTA was sig­ months was low due to very small sample sizes. Forest plots
nificantly better than FS based on the N N T o f nine, indi­ for FS vs. CH pulpotomies for all follow-up times (12, 18, and
catin g th a t after d o in g n ine M TA p u lp o to m ie s, one 24 months) are included in Electronic Appendix: Section lOe.
failure would be prevented than if FS was used. MTA, FC, MTA vs. FS pulpotomy (24-months). Four articles compa­
and FS success rates were all significantly better than CH ring MTA to FS had a follow-up of 24 m onths.65,66,68,7'’ The
at 24 m onths (7>=<0.001). At 18 m onths, N aO C l’s success MTA overall success rate was 92.2 percent (95% Cl: 70.7,
rate was significantly less than FC (P=0.01), but other pulp­ 98.3 percent), and FS’s was 79.3 percent (95% Cl: 68.0, 87.4
otom y agents’ success rates did not differ statistically (FS percent), with the meta-analysis nearing significance (/->=0.06)
vs. laser; FS vs. NaOCL; and CH vs. laser). At 12 months, favoring MTA (RR 1.13 95% Cl: 1.00, 1.29). The N N T of
p u lpoto m y success rates for FS vs. laser and MTA vs. nine was significant (Figure 6). The quality of the evidence for
Biodentine were not significantly different. The Summary this outcome at 24-months was moderate due to small sample
of Findings for all the pulpotomy studies at their maximum sizes. Forest plots for MTA vs. FS pulpotomies for all follow­
length of follow-up are included in the Electronic Appen­ up times (12 and 24 months) are included in Electronic Ap­
dix: Section 10. pendix: Section lOf.
FC vs. M TA p u lp o to m y (24-m onths). E ight articles FC vs. NaOClpulpotomy (18-months). Two articles com­
comparing FC to MTA had a follow-up of 24 months.16,30,65'70 paring FC to N aO C l had a m axim um follow -up o f 18
The FC overall success rate in these articles was 85.0 percent months.63,65 The FC overall success rate was 98.1 percent (95%
(95% Cl: 76.3, 91.0), while MTA’s was 89.6 percent (95% Cl: 97.6, 99.7 percent) and NaOCl’s was 82.9 percent (95%
Cl: 82.5, 94.0), with the meta-analysis favoring neither agent’s Cl: 68.3, 91.6%), with the meta-analysis indicating FC was
success (RR 1.04 95% Cl: 0.98, 1.11) (/>=0.15). The quality of the significantly better than N aO C l (RR 1.20 95% Cl: 1.04,
evidence for this outcome at 24-months was high due to no 1.40) (7A0.01). The N N T of six was significant (Figure 7).
GRADE issues (Figure 4). Forest plots for FC vs. MTA pulp­ The quality of the evidence for this outcome at 18-months was

20 V IT A L PULP TH E R A P Y
P E D IA TR IC D E N TIS T R Y V 39 / NO 1 JAN I FEB 17

Overall success, low and unclear risk of bias trials, 24 months *

MTA CH Risk Ratio Risk Ratio


Study or Subgroup Events Total Events Total Weight IV. Random, 95% Cl IV. Random, 95% Cl

Celik et al , 2012 82 87 22 47 67 6% 2 01 11.48.2.74] ........■


Moretti et al.,2008 14 14 6 14 18 8% 2 23 |1 24. 4.01]
Sonmez et al., 2008 10 15 6 13 13 7% 1 44 [0.73, 2 87]

Total (95% Cl) 116 74 100.0% 1.96 [1-52.2.53]


Total events 106 34

Heterogeneity Tau* = 0 00; Chi* = 0 97, df = 2 (P = 0 61), P=Q%
Test for overall effect Z = 5 20 (P < 0.00001)
oh oh t!s 1
Favors CH Favors MTA

RD = 0 .4 6 (0.30, 0.61), N N T = 3 (2, 4 ) sig nifican t

Figure 5. Forest Plot for Pulpotomy Success for FC vs. MTA at 24 months.

Overall success, low and unclear risk of bias trials, 24 months *


MTA FS Risk Ratio Risk Ratio
Study or Subgroup Events Total Events Total Werght IV. Random. 95% Cl IV. Random, 95% Cl

Doyle et al . 2010 45 47 34 46 30 7% 1 30(1.08,1 55]


Erdem et a l. 2011 24 25 23 25 41.1%
Fernandez et a l, 2013 20 20 12 14 21 5%
Sonmez et a l. 2008 10 15 11 15 67%

Total (95% Cl) 107 100 100.0% 1.13 [1.00,1.29J


Total events 99 80
Heterogeneity Tau* = 0 01. Chi* = 4 31, df= 3 (P = 0 23). I1•= 30%
05 07 15
Test for overall effect Z = 1 9 2 (P =; 0 06)
Favors FS Favors MTA

RD = 0.11 (0.00, 0.22), N N T = 9 sig nifican t

Figure 6. Forest Plot for Pulpotomy Success for MTA vs. FS at 24 months.

Overall success, low and unclear risk of bias trials, 18 months *

FC NaOCL Risk Ratio Risk Ratio


Study or Subgroup Events Total Events Total Weight IV, Random, 95% Cl IV. Random, 95% Cl

Farsi et a l, 2015 25 25 20 24 59 8% 1 20(0 99. 1 45]


Fernandez el a l, 2013 25 25 14 17 40 2% 1 22 [0 96. 1 54]

Total (95% Cl) 50 41 100.0% 1.20 [1.04,1.40)


Total events 50 34
Heterogeneity Tau*=0 00. Chl*= 001. df = 1 (p = 0 91);P=0%
Test for overall effect Z = 2 47 (P = 0 01)
Favors NaOCL Favors FC

RD = 0.17 (0.05, 0.29). NN T = 6 (4, 2 0 ) sig nifican t

Figure 7. Forest Plot for Pulpotomy Success for FC vs. N aO C l at 18 months.

* CH=Calcium Hydroxide. RD=Risk Difference. N N T=N um ber Needed to Treat.


CI=Confidence Interval. IV, Random=inverse variance random-effect model. df=degrees o f freedom.

moderate due to small sample sizes. Forest plots for FC vs. analysis favored neither type of pulpotomy (RR=1.07 95% Cl:
N aO C L pulpotom ies for all follow-up times (12 and 18 0.91, 1.25) (T^O.41). Forest plots for CH vs. Laser pulpotomies
months) are included in Electronic Appendix: Section 1Og. for 12 and 18 months follow-up are included in Electronic
FC vs. Laser; FS vs. NaOCl; CH vs. Laser pulpotomy (18- Appendix: Section lOj.
months). The quality of the evidence for the outcomes of these FS vs. Laser; MTA vs. Biodentine Pidpotomy (12-months).
agent comparisons at 18-months was low due to small sample The quality of the evidence for these outcomes at 12-months
sizes. Two articles compared FC to laser, 17,24and the m eta­ was very low due to small sample sizes and short follow-up
analysis favored neither type of pulpotomy (RR 1.14 95% Cl: duration. Two articles compared FS to laser,17,76 and the meta­
0.91, 1.43) {P=0.27). Forest plots for FC vs. Laser pulpotomies analysis favored neither type of pulpotomy (RR 1.06 95% Cl:
for all follow-up times (12 and 18 months) are included in 0.94, 1.19) (/L0.34). Forest plots for FS vs. Laser pulpotomies
Electronic Appendix: Section lOh. Two articles compared FS for 12 months follow-up are included in Electronic Appendix:
to NaOCL,63,65 and the meta-analysis favored neither type of Section 10k. Two articles compared MTA to Biodentine,64,77
pulpotom y (RR 0.99 95% Cl: 0.85, 1.16) (T^O.88) Forest and the meta-analysis favored neither pulpotomy (RR=1.01
plots for FS vs. NaOCl pulpotomies for all follow-up times (12 95% Cl: 0.94, 1.09) (^ G .8 3 ). Forest plots for Biodentione
and 18 months) are included in Electronic Appendix: Section vs. MTA pulpotomies for 12 months follow-up are included
lOi. Two articles compared C H to laser,17,24 and the meta­ in Electronic Appendix: Section 10 L.

V ITA L PULP T H E R A P Y 21
PE D IA TR IC D E N TIS T R Y V 3 9 / NO 1 JAN I FEB 17

Outcome moderators/factors results deep caries in primary teeth. A recent Cochrane review, pub­
We had 21 trials with 51 arms with unclear/low risk of bias lished in 2014,19 on the treatment of deep caries in primary
that lasted for 24 months, and all trials involved molars. Mean­ teeth, had several limitations in comparison with the current
ingful testing was not possible for the majority of the factors/ review. First, it did not include the treatment option of IPT
modifiers due to a low number of trials in each comparison, and limited reporting of treatment approaches for vital primary
incomplete data reporting, missing data, or unbalanced event teeth to DPC and pulpotomy. The omission of IPT was con­
distribution. The three exceptions were for type of final restora­ sidered to be a shortcoming, as studies of IPT have been avail­
tion (stainless steel crowns (SSC) vs. fillings), study design able in the literature for more than 15 years, and it is listed as
(split-mouth design vs. parallel design) and rubber dam use (yes a treatment option in the Clinical Guidelines for Pulp Therapy
vs. no). of Primary Teeth of the AAPD.3 The current review found
For the type of final restoration, we compared the SSC six IPT articles that we included in our systematic review in­
success rate of 82.4 percent with the intracoronal restoration volving four investigations at different time frames.6' 10,28 IPT
success rate of 84.2 percent, and there was no significant differ­ had a 94.4 percent success rate at 24 months, which we believe
ence at 24 m onths using the sub-group analysis (/VO.697) supports it’s use as a VPT option.
and meta-regression analysis (/VO.6939). In addition, we com­ A second issue of the Cochrane review was their failure to
pared success rates in split-m outh and parallel arm studies, adequately represent the success rates of formocresol in their
and there were no significant differences between them using final recommendations. Despite its equal performance with
the sub-group analysis (/VO.746) and m eta-regression MTA and FS, the authors omitted reference to it in their final
analysis (/>=0.7467). For use or non-use of rubber dam, the conclusions. The single sentence used to downgrade formocresol
arms from 41 studies using rubber dam were compared to the appeared to misrepresent the reference, Milnes78, who actually
arms of six that did not; pulp therapy was more successful specified that formocresol is safe as currently used in dentistry
when rubber dam was used, but not significantly more, so at for vital pulp therapy/8 Milnes noted that while the Interna­
24 months using the sub-group analysis (/VO.334) and meta­ tional Agency for Research on Cancer (IARC) reclassified
regression analysis (/VO.3299). formaldehyde in 2014 from a “probable” to a “known” carcino­
gen, this classification is not an assessment of risk but an
Sensitivity analysis attempt to answer the question of whether, under any circum­
We conducted sensitivity analysis by including high ROB trials stances, a substance could produce cancer in humans. 78 Milnes
in the meta-analysis, and the forest plots are included in the explained “the facts are that formaldehyde occurs naturally
Electronic Appendix: Section 10a-l. The inclusion of high throughout the body, there are multiple pathways for detoxifi­
risk of bias trials did not change the RR more than five percent. cation, and only microgram quantities of formaldehyde are
In one analysis, MTA vs. FC at 24 months, the RR became applied to pulp tissues during pulpotomy procedures for mere
statistically significant (/VO.01) when high ROB trials were m inutes”. He further stated, “considering these facts, the
included (Electronic Appendix: Section 10a). We also intended negative findings provide convincing evidence that exposure of
to include industry-funded trials in the sensitivity analysis, but children to the formaldehyde component of formocresol during
there were none. a pulpotomy is insignificant and inconsequential.”78 While we
do not intend to promote formocresol as a primary tooth VPT
Discussion agent, we felt the evidence showed that FC ’s success rates
The results of this systematic review and meta-analysis showed equaled or surpassed those of other studied agent, and this fact
variable success rates and levels of evidence for the treatment must be acknowledged.
of deep dental caries in primary teeth. The 24-month overall A third limitation of the Cochrane Review was missing
success rates for IPT, DPC, and pulpotomy were 94.4 percent, studies. The current review found five studies from 2012 and
88.8 percent, and 82.6 percent respectively. They were all viable before that were not included in the 2014 Cochrane Re­
options for treatment of deep caries in primary teeth, but IPT, view.6'39'47'79,80 In addition, the Cochrane review included data
MTA pulpotomy, and FC pulpotomy had higher quality evi­ from six-months observations, which is a very short time to
dence at 24 months to support their use. MTA and FC 24- determine success of VPTs and a time frame when most treat­
month success rates were the highest of all pulpotomy types in ment options are found to be highly successful. Finally, the
this time frame and did not differ statistically. At 24 months, Cochrane review did not attem pt to standardize the widely
MTA, FC, and FS success rates were all significantly better in divergent reports of success and failure rates as was done in
their meta-analyses than CH ; therefore, we do not recom­ the present report.
m end the use of C H pulpotom y. MTA was significantly
better than FS with a moderate level of evidence, which calls Strengths and weaknesses
into question using FS as a pulpotomy agent. At 18 months, T he current systematic review followed the recom m enda­
FC ’s pulpotom y success rate was significantly better than tions in the Cochrane Handbook for Systematic Reviews of
NaOCl’s but with a low quality of evidence. Practitioners who Interventions.35 We conducted screening and data extraction in
use NaOCl pulpotomy should consider other more successful duplicate, pooled split-mouth and parallel trials, and conducted
pulpotomy types with higher qualities of evidence. All other the assessment of the quality of the evidence using the GRADE
pulpotom y agents’ success rates had shorter follow-ups and approach.
either did not differ statistically from MTA and FC, or there We believe an additional strength of this study was the
were no studies we could use in a meta-analysis comparison. development of rules that allowed recalculation of the success
rates reported in the different studies to ensure they were all
Results in context with previous studies standardized for use in the meta-analysis. However, the un­
The current review was more complete than previous sys­ standardized reporting, in some cases, made it impossible to
tematic reviews for evaluating the literature for treatment of accurately combine data for the meta-analysis.

22 V ITA L PULP T HERAPY


P E D IA T R IC D E N T IS T R Y V 39 I NO 1 JA N I F EB 17

Weaknesses of the present report included the limited in managing a vital primary tooth with deep caries. A more
responses that we received from primary study authors to clarify conservative approach to caries removal, that of leaving caries-
issues related to risk of bias or data reporting. Another weak­ affected dentin to avoid pulp exposure (IPT), was supported
ness was that the only non-English language articles reviewed by the evidence reported here. When removal of caries resulted
were in Spanish and Portuguese. We also were unable to assess in a small carious pulp exposure of one mm or less, our meta­
publication bias due to the limited number of included studies analysis showed that direct pulp capping, a procedure that the
per outcome; however, many of our included studies reported current Practice Guideline does not recommend, is an option.
no differences between groups, suggesting limited publica­ This review also suggested that the choice of IPT liner or DPC
tion bias. capping agent does not impact success of these procedures.
We had to combine trials judged as unclear risk of bias These findings will need to be reflected in the revised Practice
with low risk of bias in the analyses due to the relatively small Guideline. The choice of pulpotomy agents (MTA or FC) can
number of trials found in each comparison and the extremely now be recommended with a higher degree of confidence.
small number of low risk of bias trials. Since the unclear do­ Additionally some materials can be removed from the choices
main was related to insufficient reporting from the original (CH) or given reduced recommendations (NaOCl, laser, FS)
authors, it was not possible to estimate the amount and direc­ based on the evidence presented in our meta-analyses.
tion of bias, if any. It should be noted that all included trials O ne o f our objectives was to determ ine if specific
satisfied one of the critical domains from the Cochrane tool, moderators/factors affected VPT success. Our ability to accu­
randomization, which reduces selection bias. rately do so was impacted by the small num ber o f trials in
each comparison, as well as incomplete and missing data and
Quality of evidence/limitations unbalanced event distribution, all of which severely limited our
The quality of evidence for the three treatment options, IPT, power to test the effect of many of the moderators-/factors. Only
DPC, and pulpotomy, varied from high to very low. This vari­ the type of final restoration, study design, and use of rubber
ance was dependent on issues of precision associated with sample dam could be evaluated, and there were no significant differ­
size and the result of limited times of observation for some ences in the effect of any of these moderators/factors on the
agents/techniques. An assessment of the forest plots comparing success of the VPT procedures.
the different pulpotomy treatments at different times of obser­
vation, e.g. 12, 18, 24, months, demonstrated that differences Implications for research
between treatm ent medicaments became larger with longer Authors of future studies are strongly encouraged to adopt a
times of observation. Some of our studies had only 12 or 18 standardized approach to report the results of their investiga­
months observation, and the differences in those outcomes tions, such as the CONSORT checklist.88 The current review
might have become significantly different with increased times found serious problems during data extraction, which had the
of observation. For instance the meta-analysis of FC vs. NaOCl potential to affect the validity and reliability of the data in­
at 12 months showed the RR=1.06; P=0.22, but at 18 months cluded in the meta-analyses. The inconsistencies and lack of
the meta-analysis showed the RR=1.20; P=0.01, indicating a standardization in the way success rates were reported made it
significant difference. Therefore our reported finding that impossible to combine data from studies without impacting
NaOCL was less successful than FC for pulpotomy may have the validity of the final analyses. For example, some authors re­
increased in magnitude with longer times of observation. ported normal, uneventfully exfoliated teeth as dropouts and
removed them from the calculations for success.17,24'26 Others
Implications for practice reported a failure in one time frame, but did not carry that fail­
These results suggest the amount of caries-affected dentin re­ ure forward to the next time frame.17,24,25 Some studies reported
moval is an important factor that should be considered when overall success as various combinations of clinical and radio-
choosing a VPT treatm ent option. Indirect pulp therapy graphic success.6,10,11,13,18,27'31 Some authors provided detailed
involves less tissue removal compared to DPC and pulpotomy. flow charts, but the data presented in these flow charts did not
IPT does not expose or damage the pulp and represents a match the data reported in the text of the articles. Others had
biological approach to pulp therapy whereby the pulp is no charts or tables and only reported data in the text of the
allowed to heal from a deep caries insult. Additionally, IPT manuscript. One well-designed, long-term study could not be
success rates appear to be equal or more successful compared included, because it was not possible to extract the data due to
to pulpotomy and DPC success rates at 24 months. The DPC their unique method of reporting observations.89
meta-analysis result at 24 months indicated the use of DPC In order to ensure the data were counted the same across
for pinpoint carious exposures (one mm or smaller) may be a studies, we developed a set of rules to apply during data extrac­
viable treatment option. Pulpotomy continues to be a success­ tion to deal with the inconsistent methods of reporting results;
ful option for VPT when carious exposures are encountered. therefore, our data reported for some studies does not match
Our results suggest that two agents, MTA and FC, are the most the data reported in those studies.6,10,12,16,17,21,22,24'29 To overcome
successful over time with the highest level of evidence. these issues of inconsistent reporting and the need to recalcu­
The results of this systematic review and meta-analysis will late data, it is recommended a set of guidelines for reporting
inform a revised Guideline for Pulp Therapy for Primary Teeth outcome data be developed. Standardization of dropout re­
for the AAPD that will now be evidence-based. Our findings porting of normally exfoliating teeth is needed, including
support the diagnostic decision that the indications are the flowcharts that consistently show failures over time. It is
same for all three VPT treatm ent options investigated, IPT, recommended that outcomes be reported as failed teeth divided
DPC and pulpotomy, and the only variable driving the treat­ by total teeth for each time frame for each material, as well
ment approach is the amount of caries-affected dentin removed. as percentages. Additionally, criteria for determining clinical,
The comparable success rates for all three VPT treatment options radiographic, and overall failure varied among studies, an issue
provide more latitude in treatment choices for the practitioner previously noted by Smail-Faugeron, et al.90

V IT A L P U L P T H E R A P Y 23
P E D IA TR IC D E N TIS T R Y V 3 9 I NO 1 JAN I FEB 17

Conclusions concept and design, data extraction, initial writing, and revision
Based on the results of this systematic review and the meta­ of manuscript. Dr. Abdullah A. Marghalani: statistical analysis
analyses of VPT in primary teeth, the following conclusions and critical revision of manuscript. Dr. Shahad AlShamali: cri­
can be made: tical revision of included studies and statistical support. Ms.
1. The success rate for IPT was 94.4 percent at 24 Laurel Graham: manager of systematic review process, initial
months, and the finding that liner material did not writing and critical revision of manuscript, and search strategy
affect the IPTsuccess was based on a moderate quality development.
of evidence.
2. The success rate for DPC of one mm or less carious Conflicts o f interest. Dr. Seale is Editor in Chief of the
pulp exposure was 88.8 percent at 24 months, and journals of the American Academy of Pediatric Dentistry, and
the finding that the pulp capping agents did not receives payment for her services. Dr. James Coll is a Section
affect success was based on a low quality of evidence. Editor for Pediatric Dentistry, and Drs. Marghalani, and Vargas
3. The combined success rate for all pulpotomy agents are Ad Hoc reviewers for Pediatric Dentistry.
in the meta-analyses (MTA, FC, FS, N aO Cl, CH,
and laser) was 82.6 percent. References
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