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International Journal of Paediatric Dentistry 2016; 26: heterogeneity between these; two of the studies
412–425 reported non-comparative methodologies and
results when compared, and were not analysed.
Objective. To conduct a systematic review and Finally, two studies compared a mixture of tetra-
meta-analysis to assess the findings on the clinical cycline isomer, an acid, and a detergent (MTDA)
efficacy of intracanal irrigants employed during or oxidative potential water (OPW) to sodium
pulpectomy of primary teeth. hypochlorite (NaOCl), without showing significant
Methods. A systematic search was performed in heterogeneity; therefore, their combined outcomes
electronic databases and peer-reviewed paediatric were included. Both fixed and random mixed
dentistry journals to find relevant studies. Titles, models resulted in a non-significant weighted
abstracts, and full-text papers were located, mean difference between treatments, according to
screened, and assessed independently by two a forest plot.
reviewers, and a meta-analysis was performed. Conclusions. More studies are required with ade-
Results. The search identified a total of 775 quate quality, as well as a full-result report,
records; 46 were selected and reviewed in full including summary measurements of both
text. After screening, seven studies met the eligi- response variables and effect size, to determine
bility criteria for inclusion. Three studies com- the most effective irrigant agents for use in
pared the 2% chlorhexidine and saline solutions, pulpectomies.
but no analysis could be performed because of the
412 © 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Intracanal irrigants for pulpectomy 413
those who are less experienced2,4. Thus, it is point were considered as eligible. Included
challenging for paediatric dentists to choose the were dental randomized controlled clinical
most appropriate irrigant agent when perform- trials (RCTs) – parallel groups, crossover or
ing pulp canal treatments. Although several split-mouth designs – observational, prospec-
in vitro, ex vivo, and in vivo approaches have been tive, or retrospective studies, and reviews of
applied in efforts to establish the effectiveness of the narrative literature. Studies of permanent
diverse disinfecting substances, the irrigating teeth, case reports (or case series), in vitro or
solution that should be considered the ideal animal studies, abstracts, and unpublished
agent for employment during pulpectomies in data were excluded. Intervention, and control
paediatric dentistry remains an issue5–7. and outcome parameters were selected in
Currently, no data from systematic reviews, accordance with the following PICO criteria:
including meta-analyses, are available regarding Population: Children and adolescents up to
this clinic topic. Therefore, in the light of the 12 years of age.
need for comprehensive summaries to contrast Interventions: Intracanal irrigant and chemo-
various available pulpectomy irrigants in paedi- mechanical debridement in primary teeth
atric dentistry, the purposes of this study were Control: Reference irrigant (comparison)
to identify, assess, and summarize the existing Outcome: Effectiveness of the interventions
knowledge and to undertake a systematic (clinical, radiographic, or microbiological
review with a meta-analysis of randomized con- results)
trolled trials, observational studies, and review
articles that have assessed and estimated the
Literature search strategy and data extraction
clinical efficacy of different intracanal irrigants
commonly employed during pulpectomy in pri- The following databases were searched with-
mary teeth. The null hypothesis was that there out language or publication date restrictions:
were no differences in clinical effectiveness MEDLINE (via PubMed), Cochrane Library,
among these agents when performing biome- EMBASE (Elsevier Science), Google Scholar,
chanical disinfection of primary pulp canals. SCOPUS Web of Science, ScienceDirect, EBS-
COhost, Wiley Online Library, OVID, Springer,
Latin Index, and SCIELO. The search algorithm
Materials and methods
was as follows: ((‘Pulpectomy’ [Mesh] AND
This systematic review and its meta-analysis ‘Root Canal Irrigants’ [Mesh]) AND ‘Tooth,
were prepared following PRISMA (Preferred Deciduous’ [Mesh]. In addition, we hand-
Reporting Items for Systematic Reviews and searched the content pages of eight, interna-
Meta-Analysis) principles by Liberati et al.8, the tional peer-reviewed paediatric dentistry
Cochrane Group fundamentals, and the recom- journals (1980 to present), including the
mendations of Higgins and Green9. Initially, a following: Journal of Clinical Pediatric Dentistry
protocol was developed that specified in (formerly known as Journal of Pedodontics);
advance it and documented the entire process Pediatric Dentistry; Journal of Dentistry for
of the systematic review; it described and Children; International Journal of Paediatric
defined the background, a focused clinical ques- Dentistry; International Journal of Clinical Pedi-
tion, the hypothesis to be tested, explicit eligi- atric Dentistry; European Archives of Paediatric
bility criteria for individual studies, replicable Dentistry; Pediatric Dental Journal, and European
search methodologies, and techniques for statis- Journal of Paediatric Dentistry. The reference lists
tical analysis (meta-analysis) of the pooled, of the downloaded papers were also thor-
extracted data. oughly screened.
Then, the authors’ names, titles, abstracts,
keywords, design, and evaluation length of
Selection criteria
each reference, identified according to the
Articles reporting clinical, radiographic, or selection criteria, were objectively and inde-
microbiological results with irrigant solutions pendently screened by two blinded reviewers
in primary pulpectomies as the primary end- (GFJ-A and EV-V); any difference between
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
414 A. Pozos-Guillen et al.
them was resolved according to discussion Oxford Centre for Evidence-Based Medicine
and consensus or with the involvement of a (OCEBM)11 criteria; these are described later
third reviewer (PGA-J). These selected studies and are both considered suitable for reducing
were downloaded as full-text papers and were potential biases in RCTs12,13 (Table 1). The
later rescreened in detail by the same review- reviewers scored each scale section based on
ers to confirm whether they complied with their judgment and knowledge for determin-
the inclusion criteria. Also, an in-depth ing the respective section weight with regard
inquiry was performed into duplicate report to the final results and conclusions of each
publications to avoid introducing bias due to individual study. The maximal value was 16,
double counting, by means of juxtaposing and this value was correlated with the quality
author names, treatment comparisons, sample of the study, but the individual point could
sizes, and results. be assessed for an individual value in the
Data were extracted independently by the study (Table 2); for type of result appraisal,
other reviewers (PGA-J and GRJ-A) from the such as clinical, radiographic, and microbio-
selected papers, in blinded fashion, using a logical (or another measurement type), out-
developed data extraction sheet (based on the come success rates were also evaluated10,14,15.
Cochrane template)8. If the reviewers had any If necessary, the corresponding authors were
data-related questions or needed additional contacted to obtain information concerning
information, the authors of the papers were unclear or missing data ‒ for example, numer-
contacted. In reports of which one of the ical data only presented graphically ‒ which
reviewers appeared as an author, the assess- were considered significant by the reviewers
ment was performed by another reviewer to for the aim of performing the meta-analysis.
prevent any potential conflicts of interest.
Meta-analysis (quantitative analysis)
Quality appraisal
Meta-analysis was performed if the studies
The methodological quality and validity of were homogeneous, and this was verified sta-
the included studies were independently tistically using the inconsistency Q test. An
assessed by two blinded reviewers employing estimated overall-effect size of the papers
Grading of Recommendations Assessment, included in the analysis was obtained.
Development, and Evaluation (GRADE)10 and Summary measurements (means, standard-
Table 1. Evaluated characteristics in each selected study.
Section Description
Sample size calculation Indicates whether the calculation of sample size or a pilot study is present or not on the basis of the
type of methodological design, based on the statistical criteria16–19.
Randomization Indicates whether the process of randomization for the different experimental groups is present or not,
which can usually be determined by whether the process is performed when the baseline
characteristics of the groups are homogeneous18,20.
Randomization (Method) Indicates whether the method of randomization is described and executed properly, and again, we
recommend observing whether the groups are homogeneous20,21.
Blinding or masking Indicates whether the method of blinding is present and whether or not it is described22,23.
Follow-up Indicates whether follow-up of patients was complete or incomplete and, in this case, that lost cases
were evaluated24.
Response variable Based on the characteristics of the variable response or outcome, this variable can determine its
objectivity or subjectivity and, in keeping with this ability, the clinical implications that might have an
impact on the results and conclusions25.
Concordance of the In the case of the response variable being qualitative, a procedure is recommended for concordance
measurement method between the observers of the event-of-interest, as well as whether quantitative laboratory processes
are to follow recommendations for quality26,27.
Assumptions of the Indicates whether the assumptions were evaluated for correct application of the statistical test25,28,29.
statistical tests
Results Indicates whether the results were fully reported, it being important to report the size of the resulting
effect in each analysis to be performed, with its respective error30,31.
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Intracanal irrigants for pulpectomy 415
Total
13
12
13
11
10
9
12
deviations [SD]) were extracted from the
results and expressed as continuous data in
0 = incomplete,
1 = complete
the study groups. The weighted mean differ-
ence was chosen as the point estimate, with
Results
its corresponding 95% confidence interval
1
1
0
1
(95% CI), calculated from a restricted maxi-
categorical data,
0 = Not present,
2 = present and
1 = Not clear/
Assumptions
1
0
0
0
size of the averaged outcomes for each indi-
0 = Not present,
Concordance of
laboratory
method
testing
2
2
2
2
alpha value was set at 0.05.
2 = quantitative
0 = qualitative
1 = qualitative
subjective,
objective,
Response
Results
variable
2
2
2
2
Literature findings
1 = intention to
0 = incomplete,
2
2
2
2
and described
1 = Not clear/
2 = present
0
0
0
0
not described,
1 = adequate
0
0
0
1
(homogeneous
1 = Not clear,
2
2
2
2
pilot study,
2 = Present
calculation
1
1
1
2
P
P
P
P
Pruck-satham-
Jolly et al.35
Louwakul &
Gonzalez
et al.32
et al.34
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
416 A. Pozos-Guillen et al.
comes and results in colony-forming units CFU/mL. Based on the homogeneity between
(CFU/mL), except for two trials, one of which the studies, it was decided to combine the
reporting the relative quantifying (RQ) results, despite their being different experi-
increase in gene expression, and the other, a mental groups. Because the purpose of the
dichotomous (success/failure) result. comparison was an assessment of the global
efficacy regarding NaOCl, independent of the
comparison group, a quantitative meta-analy-
Qualitative synthesis sis was conducted with these two studies.
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Table 3. Individual characteristics of the studies.
Initial Evaluation
Study Age (range) Methods Characteristic of patients sample Irrigant agent Final sample period
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
• Presence of a radiolucent area in
the furcal or periapical regions
• Carious lesion without direct expo
sure to the oral environment
• Sufficient isolation and sterility
control in the operative field to demon
strate no bacterial growth
Jolly et al.35 (6–12) Randomized, • 60 children with pulpally involved 15 Saline solution 15 Pre-irrigation
parallel primary maxillary molars Post-irrigation
clinical trial • Children with an acute apical 15 Chlorhexidine 15 Pre-irrigation
abscess of the maxillary primary molars gluconate 2% Post-irrigation
• Children not receiving systemic
15 Calcium 15 Pre-irrigation
antibiotics within the past 3–6 months
hydroxide 4% Post-irrigation
15 Propolis 4% 15 Pre-irrigation
Post-irrigation
Intracanal irrigants for pulpectomy
(Continued)
417
418
Table 3 (Contd.)
Initial Evaluation
A. Pozos-Guillen et al.
Study Age (range) Methods Characteristic of patients sample Irrigant agent Final sample period
Tulsani et al.7 (4–8) Randomized, • 40 primary anterior teeth 10 Isotonic saline solution 0.9% 10 Post-irrigation
parallel • Referrals for dental treatment 15 2.5% NaOCl 15
clinical trial • Patients without systemic 15 MTAD (Biopure) 15
conditions
• Teeth primary with necrotic pulp,
asymptomatic, through clinical and
radiographic assessment
• Without surgical interventions
• Without periodontal lesions
Verma et al.36 (4–7) Randomized, • 70 primary teeth 35 Isotonic saline solution 0.9% 35 Pre-irrigation
parallel • Children with good general health, Post-irrigation
clinical trial without histories of antibiotic coverage 35 Water-soluble propolis 25% 35 Pre-irrigation
and radiographic evidence of carious Post-irrigation
pulp exposure
Farhin et al.37 (3–7) Randomized, • Patients in good health 30 NaOCl 1% 30 Pre-irrigation
parallel • 60 primary molar teeth that con 30 30 Post-irrigation
clinical trial tain at least one root canal with necro 30 MTAD 30 Pre-irrigation
sis pulp, abscess, or fistula 30 30 Post-irrigation
• Injury to decay without direct pul
pal exposure to the oral environment
• Presence of a radiolucent area in
the furca or periapical region
• Sufficient tooth structure to place
a rubber dam
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Table 4. Individual results of individual studies.
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Valdez- 20 NaOCl 1% 20 Pre-irrigation ND ND 1.569109 3.369108 CFU/mL Significant OPW was as
Gonzalez, 20 20 Post-irrigation 0 0 difference in effective as
et al.34 20 OPW 20 Pre-irrigation 1.639109 4.189108 favour of the NaOCl
20 20 Post-irrigation 59107 1.539108 experimental
group when
evaluated
pre- and
post-irrigation
(Continued)
Intracanal irrigants for pulpectomy
419
420
Table 4 (Contd.)
Jolly et al.35 15 Saline solution 15 Pre-irrigation ND ND Aerobes (7.13) 1.19 CFU/mL In all groups, Chlorhexidine
Post-irrigation Anaerobes (7.4) 1.24 a significant proved to
Aerobes (3.8) 1.08 decrease in be a superior
Anaerobes 0.91 mean aerobic antimicrobial
(6.40) CFU was agent
15 Chlorhexidine 15 Pre-irrigation Aerobes (7.13) 1.19 observed; against both
A. Pozos-Guillen et al.
(Continued)
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Table 4 (Contd.)
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
MTAD group; being
when both a viable
groups were alternative
compared in
post-irrigation,
MTAD was
superior
Intracanal irrigants for pulpectomy
421
422 A. Pozos-Guillen et al.
Identification
Records identified through Google Records identified through other Records identified through other
Scholar databases sources and manual searching
667 104 4
Screening
Valdez_G_2012 OPW NaOCl 20 50000000 153000000 20 0.00000001 0.00001 0.45 [–0.18; 1.08] 39.3% 42.5%
Farhin_K_2015 MTA NaOCl 30 183 5910 30 354.00000000 1870.00000 –0.04 [–0.54; 0.47] 60.7% 57.5%
–1 –0.5 0 0.5 1
edge gaps in strategic clinical areas and prac- involved in irreversibly inflamed/infected or
tice-relevant research activities39. non-vital primary teeth; this absence of con-
The preservation of primary teeth is one the sensus is probably due to the lack of research-
most important aims of paediatric dentistry. based evidence to support the use of any ‘best’
The aim is to maintain the harmonious agent2. In their narrative review of intracanal
growth and development of arch length and irrigants for primary teeth, Kaur et al.4 pro-
occlusal balance, with optimal function for posed six requirements that the ideal irrigant
swallowing, chewing, speech, and aesthetics4. must possess: (1) broad antimicrobial spec-
Therefore, pulp therapies should be performed trum, (2) high efficacy against anaerobic and
with high levels of quality to ensure a maxi- facultative microorganisms organized in bio-
mally successful clinical result. Currently, films, (3) ability to dissolve necrotic pulp-tis-
there is no agreement among paediatric den- sue remnants, (4) ability to inactivate
tists concerning the best intracanal irrigant endotoxin, (5) ability to prevent the formation
solution for use against pulp pathogens of or to dissolve the smear layer during instru-
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Intracanal irrigants for pulpectomy 423
mentation, and (6) a non-toxic (to periodontal is, in general, poor, and inadequate for ensur-
tissues), non-caustic nature that does not ing that the results can be considered reliable
cause an allergic reaction. In this same narra- and reproducible; this issue has been associ-
tive review, the authors concluded that, dur- ated with an increased tendency to overesti-
ing instrumentation, canals should be mate the experimental intervention efficacy
irrigated utilizing copious amounts of NaOCl, reported, which occurs in approximately 35%
and once the shaping procedure is completed, of meta-analyses published in Medicine, as
EDTA or citric acid should be employed; these determined by the Consolidated Standards in
authors also mentioned that chlorhexidine or Reporting Trials (CONSORT) Group42.
MTDA are strongly recommended as best final Therefore, and according to this collected
irrigant agent prior to canal drying and filling. information, authors are encouraged to com-
Although a comprehensive search was per- ply carefully with the accepted quality
formed, and a substantial number of articles methodologies (e.g., the CONSORT state-
were reviewed for the purposes of the present ment) in order to perform and publish more
systematic review, it is possible that some transparent and better designed RTCs, system-
papers were missed due to the limitations atic reviews, and meta-analyses10. Although
inherent in the process; however, we are the quality of paediatric- dentistry RTC
confident that the majority of potentially suf- reports might constitute the major limiting
ficient published papers with quality method- factor in determining and reporting all valid
ologies were retrieved. and important outcomes with regard to esti-
After critically evaluating the included stud- mates of treatment effects, the value of meta-
ies, some variations in restrictions among jour- analyses ‒ that is, the highest quality evidence
nals were found, and search strategies for design of published clinical literature ‒ is quite
relevant information or data in the text of the important. This type of study guarantees that
papers were not always feasible. Regarding this the pooling of relevant results from primary
limitation, the majority searches might have studies is as valid and bias free as possible43.
had constraints; these included small sample
sizes, limited time or financial resources, inac- Conclusions
cessible or inadequately indexed reports and
databases, or questions posed for which perti- More comparative/controlled studies are
nent evidence is not easy to find8. required with sufficient quality and adequate
This systematic review revealed a certain full-result report, including both summary
homogeneity with regard to evidence quality measurements of the response variable and
among the studies finally included, mainly the observed size effect, to determine the most
with regard to clear descriptions and the efficient intracanal irrigant agents for use in
reporting of methodological issues, such as sta- the pulpectomy treatment of primary teeth.
tistical methods (e.g., ‘intention to treat analy-
sis’), sample-size calculation procedures,
differences in outcome definitions, dropout Why this paper is important to paediatric dentists
impacts, follow-up screening, randomization • The success of pulpectomy therapy in primary teeth
depends on achieving an adequate level of disinfection
and allocation and the concealment methods
within the root canals. It is challenging for paediatric
thereof, reports of adverse events, and cost- dentists to choose the most appropriate irrigant agent
saving analyses; thus, it is more difficult to when performing pulpectomy treatments.
analyse and combine their findings. Also, addi- • In the present study, the evidence was inconclusive
from the combined findings of the selected and anal-
tional uncontrolled, confounding factors, ysed controlled clinical trials, in which the most effec-
which can reduce comparability among study tive intracanal irrigants were considered.
outcomes, must be considered for purposes of • More high-quality clinical studies are definitely
needed, with proper monitoring, and following the
analysis testing. According to Al-Namankany appropriate parameters of a clinical trial, such as those
et al.40 and Rajasekharan et al.41, the reporting suggested by the CONSORT guidelines.
quality of RTC in paediatric dentistry journals
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
424 A. Pozos-Guillen et al.
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Intracanal irrigants for pulpectomy 425
28 Field A, Miles J, Field Z. Discovering Statistics Using 37 Farhin K, Viral P, Thejokrishna P, Sajjad M. Reduc-
R. London, UK: SAGE Publications, Ltd., 2012. tion in bacterial loading using MTAD as an irrigant
29 Field AP, Gillett R. How to do a meta-analysis. Br J in pulpectomized primary teeth. J Clin Pediatr Dent
Math Stat Psychol 2010; 63: 665–694. 2015; 38: 100–104.
30 Peng RD. Reproducible research in computational 38 Foersch M, Jacobs C, Wriedt S, Hechtner M, Wehr-
science. Science 2011; 334: 1226–1227. bein H. Effectiveness of maxillary protraction using
31 Grisson RJ. Effect Sizes for Research. Hillsdale, NJ, facemask with or without maxillary expansion: a
USA: Lawrence Erlbaum Associated, Publishers, 2005. systematic review and meta-analysis. Clin Oral Inves-
32 Ruiz-Esparza C, Garrocho-Rangel A, Gonz alez- tig 2015; 19: 1181–1192.
Amaro A, Flores-Reyes H, Pozos-Guillen A. Reduc- 39 Maia LC, Antonio AG. Systematic reviews in dental
tion in bacterial loading using 2% chlorhexidine research. A guideline. J Clin Pediatr Dent 2012; 37:
gluconate as an irrigant in pulpectomized primary 117–124.
teeth: a preliminary report. J Clin Pediatr Dent 2011; 40 Al-Namankany AA, Ashley P, Moles DR, Parekh S.
35: 265–270. Assessment of the quality of reporting of random-
33 Louwakul P, Prucksathamrongkul W. The effect of ized clinical trials in paediatric dentistry journals. Int
2% chlorhexidine as root canal irrigant in pulpec- J Paediatr Dent 2009; 19: 318–324.
tomies of primary molars. Pediatr Dent 2012; 34: 41 Rajasekharan S, Vandenbulcke J, Martens L. An
192–196. assessment of the quality of reporting randomised
34 Valdez-Gonzalez C, Mendez-Gonzalez V, Torre-Del- controlled trials published in paediatric dentistry
gadillo G, Flores-Reyes H, Gaitan-Fonseca C, Pozos- journals. Eur Arch Paediatr Dent 2015; 16: 181–
Guillen A. Effectiveness of oxidative potential water 189.
as an irrigant in pulpectomized primary teeth. J Clin 42 Moher D, Jones A, Lepage L. Use of the CONSORT
Pediatr Dent 2012; 37: 31–36. statement and quality of reports of randomized tri-
35 Jolly M, Sigh N, Rathore M, Tandon S, Banerjee M. als: a comparative before-and-after evaluation.
Propolis and commonly used intracanal irrigants: JAMA 2001; 285: 1992–1995.
comparative evaluation of antimicrobial potential. 43 Bhandari M, Devereaux PJ, Montori V, Cin a C, Tan-
J Clin Pediatr Dent 2013; 37: 243–249. dan V, Guyatt GH. Users’ guide to the surgical litera-
36 Verma K, Pandey R, Khanna R, Agarwal J, Verma ture: how to use a systematic literature review and
M. The antimicrobial effectiveness of 25% propolis meta-analysis. Can J Surg 2004; 47: 60–67.
extract in root canal irrigation of primary teeth.
J Indian Soc Pedod Prev Dent 2014; 32: 120–124.
© 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd