Australian Dental Journal

The official journal of the Australian Dental Association

Australian Dental Journal 2020; 65: 158–167

doi: 10.1111/adj.12749

Atraumatic restorative treatments reduce the need for

dental general anaesthesia: a non‐inferiority randomized,
controlled trial
P Arrow,* H Forrest*
*Dental Health Services, Perth, Western Australia.

ABSTRACT
Background: A dental general anaesthesia (DGA) is commonly undertaken for the management of dental caries in young
children. A randomized‐controlled trial was undertaken to test the feasibility of using the Atraumatic Restorative Treat-
ment and Hall Technique approaches (ART/HT) to manage the dental treatment of children recommended for a DGA.
Methods: Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Aus-
tralia were randomized. Test group children were treated using the ART/HT approach and the control group under a
DGA. Children were examined after 12 months by two blinded, calibrated examiners. Analysis was on an intention to
treat basis; between and within group comparisons were undertaken using appropriate paired and unpaired tests. Logis-
tic regression was used to test restorative success, controlling for clustering of teeth.
Results: Sixty‐five children participated, (Test = 32; Control = 33). At study termination, 28 children (88%) in the ART/
HT group and 20 children (61%) in the DGA group had been provided with care, P < 0.01. Crown restorations were
protective of restorative failure in a multivariate logistic model (OR 0.05, P < 0.01).
Conclusion: Use of the ART/HT approach enabled timely dental treatment of young children recommended for a DGA,
and should be among the treatment options considered.
Keywords: Atraumatic restorative treatments, early childhood caries, minimum intervention dentistry, paediatric dentistry, restorative
dentistry.
(Accepted for publication 6 February 2020.)

introduction in the 1990s, the ART approach has

INTRODUCTION
Caries management under dental general anaesthesia
(DGA) is commonly undertaken in young children for
comprehensive oral rehabilitation. DGAs are not
without risk, and are costly to the individual and soci-
ety.1,2 In spite of a low caries experience among chil-
dren, Australia has an increasing trend of hospital
admissions for dental care among children,3 and Wes-
tern Australia (WA) leads the country in the rate of
hospital admissions for dental treatment; 7.5 per 1000
persons compared with the Australian Capital Terri-
tory at 3.4 per 1000 persons, which is less than half
that of WA in 2016–2017.4
Atraumatic restorative approaches, largely relying
on using hand instruments and without local anaes-
thesia (the Atraumatic Restorative Treatment (ART)
procedures) have been found to enable caries manage-
ment in young children without the need for specialist
referral and were also successful clinically.5,6 Since its
been shown to be clinically successful as well as being
acceptable to patients.7
Another restorative approach, the ‘Hall Technique’
(HT), in which dental caries is sealed‐in with the use
of a stainless steel crown, without any preparation of
the tooth, can be considered an atraumatic restorative
treatment.8,9 The technique has been tested in clinical
trials and has been shown to be clinically successful
and well accepted by children and their parents,10–12
and with more trials in progress.13,14
Hospital admissions for dental care are potentially
preventable with timely and adequate non‐hospital
care.15 An evaluation of DGAs in Canada indicated
that the rates of DGAs were common, at an average
cost of C$1546 per child, and in WA the cost has
been estimated at A$9 million per year.1,16 A cost
analysis comparing the treatment of ECC under a
DGA against conscious sedation found the outcomes
were better under a DGA but it was not cost‐saving.17

158 © 2020 Australian Dental Association


Although there might be a belief that care under DGA
allows for higher quality care and an efficient out-
come, interest is growing in alternative approaches to
the management of childhood caries,18,19 and recent
reports suggest that such approaches might impact
positively on the oral health of children without
adverse consequences.20 Potential alternative manage-
ment approaches to reduce DGAs have been can-
vassed,19 and the American Academy of Pediatric
Dentistry in its policy statement suggested that treat-
ments designed to postpone advanced restorative pro-
cedures be undertaken to reduce the need for a
DGA,21 Thus, the application of alternative
approaches to reduce DGA require further
investigation.
Management of the dental care for a young child
with dental decay is a complex undertaking and it is
unlikely that one approach alone can achieve all the
desired outcomes.22 Management of caries under a
DGA, for example, has been shown to have a signifi-
cant relapse rate, whereby caries recurrence rate is
high, and even when a child is older.23,24 Thus, com-
plex problems require complex interventions, and in
the case of caries among young children, interventions
are likely to be complex, involving the use of multi‐
components which require testing to evaluate their
effectiveness in every‐day practice.22
This study aimed to evaluate, using a randomized
control design, whether a pragmatic multi‐component
intervention, comprising the Atraumatic Restorative
Treatment approach and the Hall Technique (ART/
HT), would enable the provision of comprehensive
care for the treatment of dental caries, including den-
tal extractions and pulp therapy, in a primary care
setting, and thus, reduce the need for a DGA. The set-
ting for the study was within a publicly delivered den-
tal service. The primary outcome was the proportion
of children managed successfully (comprehensive care
provided) without the need for a DGA compared
against the proportion of children managed under a
DGA. Secondary outcomes were the quality of
restorations and occurrence of dental infections, and
changes in childhood oral health‐related quality of life
and dental anxiety at follow‐up between the two
groups. The hypotheses were that the outcomes would
not be inferior compared with those children managed
under a DGA.
MATERIALS AND METHODS
Ethical approval for the study was provided by Prin-
cess Margaret Hospital for Children Human Research
Ethics Committee (HREC REF 2016143EP). Partici-
pating parents provided signed informed consent.
Children seen at the Oral Health Centre of Western
Australia (OHCWA) Paediatric Dentistry Department
© 2020 Australian Dental Association
Atraumatic restorative treatments
and for whom a DGA was the recommended option
for the treatment of dental caries were invited to par-
ticipate. Children are seen at the Paediatric Dentistry
Department for specialist care on referral by their pri-
mary care provider, usually the dental care provider.
This was a pragmatic, parallel‐group, open‐label, non‐
inferiority randomized‐controlled trial (RCT). Study
participants and treating clinicians were not blinded
to treatment allocation. The OHCWA is the major
public dental facility in WA providing specialist dental
services to patients eligible for government‐subsidized
dental care (those in receipt of government benefits).
There is usually a waiting period associated with
receipt of publicly subsidized specialist dental care,
and a means‐tested co‐payment is payable. However,
it was anticipated that the DGA treatment would be
provided within a 12‐month period from receipt of
consent to participate. Children allocated to the ART/
HT arm also retained their position on the OHCWA
waiting list and, if necessary, were able to return to
the waiting list for a DGA.
Over a 12‐month period, participants were
recruited through a personal approach by the
Research Project Officer (RPO) to the parent at the
time of presentation at the paediatric dental depart-
ment for a specialist consultation at OHCWA. After
the consultation, parents were asked if a DGA
had been recommended for their child, and if the
response was “yes” then those expressing an interest
in the study were issued an information, consent and
questionnaire pack with advice to return the signed
consent and completed questionnaire via a reply‐paid
envelope. Interpreter services were used as needed to
assist parents/carers in providing informed consent. In
addition to the basic demographic information, the
questionnaire sought information on parent‐reported
child oral health‐related quality of life25 and child
self‐reported quality of life,26 child and parent dental
fear,27,28 previous DGA experience, private insurance
status and source of referral. The findings with respect
to changes in child oral health‐related quality of life
and child dental anxiety will be reported in a compan-
ion paper.
Inclusion and exclusion criteria were applied. Chil-
dren younger than six years of age who have been
recommended for a DGA to manage their dental car-
ies were eligible. Children; older than six years; or
with acute dental pain and/or infections; or with phys-
ical/mental disability which limited dental treatment
in the primary care setting; or with general or dental
developmental conditions which required specialist
care (such as, amelogenesis imperfecta, cleft lip/
palate); or who were being managed for conditions
other than dental caries were ineligible.
To minimize group imbalance, computer‐generated
blocks with varying block sizes were used for the
159
P Arrow and H Forrest
allocation procedure. On receipt of parental consent,
children were allocated into test (ART/HT) or control
(DGA) by a different project officer at a central loca-
tion (not the RPO who undertook participant recruit-
ment).
Due to logistical difficulties in arranging appoint-
ments for study participants, baseline summary caries
experience data were obtained from information
recorded by the assessing clinicians (registrars or spe-
cialists) at the OHCWA and repeat examinations to
evaluate intra‐examiner reliability were not able to be
undertaken. Participants completed a follow‐up ques-
tionnaire and an oral health assessment approximately
12 months after the date of consent. The follow‐up
examinations were undertaken by two calibrated
examiners (inter‐examiner κ = 0.89) who were blind
to the group allocation status of the participants.
The primary outcome of a child being able to be
successfully treated was obtained from clinical records
of each child allocated to the ART/HT arm and from
information provided by the OHCWA of children
treated under a DGA. Secondary outcomes of clinical
and restorative status of the tooth surfaces were eval-
uated at follow‐up during a clinical examination, car-
ried out at School Dental Service clinics under
standard lighting. Tooth status was evaluated using
the criteria for describing early childhood caries29 and
scored using the decayed, missing and filled tooth and
surfaces index (dmft/dmfs). The restorations were
evaluated and scored using the criteria for ART
restorations (Table 1).30 ART scores were dichoto-
mized into success or failure; scores 0, 1, and 7 as
success and scores 2, 3, 4, 5, 6, 8 as failed; score 9
was excluded. Restoration status was evaluated on
each surface (occlusal, mesial, buccal, distal and pala-
tal/lingual), and was scored at the tooth level with the
worst ART score being assigned. Restorative type was
dichotomized into crown or not crown (glass‐ionomer
cement, composite, and others). The presence of den-
tal infections was also recorded.
Treatment procedures
The test group was provided with care by school den-
tal therapists who had previously been trained in the
ART approach.6 Additional training in the HT was
provided, which included didactic lectures and crown
placement in clinical cases.31 Competency in the
application of the clinical procedures was based on
the successful undertaking of the procedures in clinical
cases prior to study commencement. The aim of treat-
ment was to provide comprehensive care as would be
undertaken for a child undergoing care under a DGA,
including pulp therapy and extractions, where indi-
cated. Clinicians were advised to use the ART/HT
approaches in providing restorative care and to limit
160
Table 1. Criteria for evaluation of restorations
Score Criteria
0 Present, good
1 Present, slight marginal defect for whatever reason, at any one place
which is < 0.5 mm in depth; no repair required
2 Present, marginal defect for whatever reason, any one place which
is deeper than 0.5 mm, but < 1.0 mm; repair required
3 Present, gross defect> 1.0 mm in depth; repair required
4 Not present, restoration (almost) completely disappeared; treatment
required
5 Not present, other restorative treatment has been performed
6 Not present, tooth has been extracted
7 Present, gradual wear and tear over large parts of the
restoration < 0.5 mm at the deepest point, no repair required
8 Present, gradual wear and tear over large parts of the
restoration> 0.5 mm at the deepest point, repair required
9 Unable to diagnose
the use of LA and rotary instruments (when able) for
more complex care. Radiographs were taken prior to
pulp therapy and extractions. Fluoride varnish appli-
cations were undertaken on the remaining at‐risk
tooth surfaces and parents counselled on preventive
strategies to reduce caries incidence. All treatments
were undertaken in School Dental Clinics and there
was no direct cost of care to the parents/carers.
Type of restorative care to be provided was deter-
mined by the treating clinician, based on their clinical
assessment. It is likely, and expected, that treatments
provided by non‐specialists in a primary care setting
would differ to those provided by specialists under a
DGA.32,33 Care under a DGA is likely to be more
aggressive in order to mitigate against therapy
relapse.34 In this study, and in keeping with the mini-
mally invasive restorative approaches, not every cavi-
tated lesions were necessarily restored; clinicians were
able to undertake preventive measures to arrest or
slow the progression of established disease.
For an ART restoration, the cavity was prepared
using hand instruments, without local anaesthesia. In
keeping with the pragmatic study design, the use of
the dental drill was permitted, again based on the
clinician assessment of the child’s capacity to cope
with the procedure and the clinical need, such as in
gaining access to the pulp chamber for pulp therapy.
The prepared cavity was then restored with a glass‐
ionomer cement. For a Hall crown, no tooth prepara-
tion was undertaken except for the placement of
orthodontic tooth separators as required. Pre‐treat-
ment radiographs were taken, when possible. Pulp sta-
tus of the tooth was evaluated clinically and a
suitable sized crown was then selected and cemented
with a glass‐ionomer cement if pulpal involvement
and pulpal inflammation were ruled out. Some ante-
rior teeth were also treated with crowns using pre-
formed strip crowns and glass‐ionomer cement after
caries removal with hand instruments as per the ART
technique.
© 2020 Australian Dental Association

The control group was informed of their allocation
status and advised to await contact from the
OHCWA for their DGA appointment. Treatment was
provided by paediatric dental specialists or registrars
undergoing paediatric dental specialty training at the
OHCWA.
Restorative options chosen were as per the standard
protocols of the OHCWA.
Sample size
The sample size required for the RCT was estimated
to test the primary outcome of the proportion of chil-
dren successfully managed for their dental treatment
under the two arms of the study. Success was defined
as the child being provided with necessary and needed
care (comprehensive care). It was assumed that almost
all children allocated to the DGA arm of the study
would be successfully managed (99%) and if at least
90% of the children allocated to the ART/HT arm
were able to be managed then the intervention would
be considered non‐inferior. Sample size estimation
used the ssi command implemented within STATA
with delta = 0.1, one‐sided alpha = 0.025 and 90%
power; and the sample size required was 21 per group,
after allowing for loss to follow‐up, the estimated
required sample size was increased to 30 per group.
Analysis
The multi‐component intervention was grouped into
one intervention. This was adopted in keeping with
the pragmatic study design, where a clinician, faced
with a plethora of treatment needs of a patient will
apply multiple strategies to achieve an outcome. In
this study, the outcome was to enable the provision of
comprehensive care for dental caries in a primary care
setting and to reduce the need for a DGA. The effects
of the intervention were evaluated as a grouped inter-
vention for the primary outcome and were modelled
as separate components for restoration status.
Data were analysed on an intention‐to‐treat basis at
the child level. The changes in caries experience from
baseline to follow‐up (follow‐up minus baseline),
using the dmft/dmfs index, were evaluated using
paired tests for pre‐ and post‐treatment scores (paired
t test and Wilcoxon matched‐pairs signed‐rank test); P
values < 0.05 were deemed to be statistically signifi-
cant. Estimates and their 95% confidence intervals
were also presented and 95% confidence intervals for
differences not containing zero (0) were deemed to be
statistically significant.
The number of children successfully provided with
treatment and the dichotomized ART scores (0 = suc-
cess, 1 = fail) in restorative outcomes were evaluated
using tests of proportions (Chi‐square). Univariate
© 2020 Australian Dental Association
Atraumatic restorative treatments
logistic regression was performed to evaluate factors
other than group status affecting restorative outcomes.
Factors with P‐values < 0.25 were included in the
multivariate model.
Multivariate logistic regression was undertaken at
the tooth level for evaluating restorative status, con-
trolling for within‐person clustering, using the panel‐
data analytical commands in the statistical software
(xtlogit) and multilevel modelling approach.35 Vari-
ables for inclusion/exclusion were selected based on
changes in the likelihood ratio for model fit to obtain
a parsimonious model. Group status was retained in
the model irrespective of its statistical significance.
Statistical analyses were undertaken on a personal
computer using STATA 15.36
RESULTS
The CONSORT participant flow chart is shown in
Fig. 1. Sixty‐five parent/child dyads participated in the
study. The mean interval from consent to follow‐up
dental assessment was 12.2 months (n = 58), Table 2
and Fig. 1. The majority of children had been referred
for specialist care at the OHCWA by public dental ser-
vices (School Dental Services or Government General
Dental Clinics = 60%; private dental practition-
ers = 28%; and others, such as medical practition-
ers = 12%). Fifteen participants have had a DGA
previously and few held private health insurance,
Table 2. At follow‐up, two ART/HT participants were
lost to follow‐up; one moved interstate and one failed
to attend for appointments (this participant also failed
to attend for treatment appointments). Five DGA par-
ticipants were lost to follow‐up; 2 had relocated from
Perth and three failed to attend for appointments.
At study termination, some 11 months after recruit-
ment of the last participant, not all randomized chil-
dren have had their treatment completed; more
children in the ART/HT group have been successfully
managed and had their treatment completed (n = 28,
88%) compared with the DGA group (n = 20, 61%),
Chi‐Square, P < 0.01. Of the four children not treated
in the ART/HT group, two elected to have a DGA at
OHCWA, one failed to attend for treatment appoint-
ments, and one was referred back for management
under a DGA. Of the 13 children who have not been
treated in the DGA; three were still waiting for
scheduling of their appointment; two were seeking
care from the School Dental Service; two had relo-
cated; two deferred their treatment due to costs; two
sought care privately, one is under care through the
use of relative analgesia at parent’s request, and one
withdrew from having a DGA. Five children required
an emergency DGA for extractions either while wait-
ing for treatment or were in the process of getting
care (ART/HT = 1, DGA = 4).
161
P Arrow and H Forrest

had 149 visits for care. The number of restorative fail-

ures was higher among the ART/HT group 17 (12%;
all failures were ART restored teeth and no HT
crowns failed) compared with 4 (4%, one anterior
crown failed) in the DGA group, and the mean differ-
ence was statistically significant, P < 0.01.
There were 251 restored teeth, of which 139 were in
the ART/HT group, (crowns = 46; anterior
crowns = 4, HT = 42), 112 were in the DGA group,
(crowns = 77; anterior crowns = 23, stainless steel
crowns = 54) and the difference in restorative type
(crowns vs non‐crowns) between the groups was statis-
tically significant, Chi‐square, P < 0.001. There were
42 instances in which a rotary instrument was used in
the ART/HT group (18 were for pulp therapy).
When restorative success by the type of restoration
was evaluated, there was a higher rate of failure
among non‐crown restorations; one crown restoration
(anterior tooth) was classified as failed (abscess) whilst
20 out of 128 non‐crown restorations failed (17 ART/
Fig. 1 CONSORT participant flowchart. HT, 3 DGA; Chi‐square, P < 0.001). All failures in
the ART/HT group were ART restorations; 11 in pos-
Table 2. Baseline characteristics of study participants terior teeth; three were one‐surface restorations, one
by group status (mean or percentage and 95% of which was on a posterior tooth. Of the four failed
confidence intervals) restorations in the DGA group, one was on a crowned
anterior tooth and the remaining three teeth were
Factor ART/HT (n = 32)† DGA (n = 33) P value multi‐surface restorations, one of which was on an
Sex Male = 41% Male = 61% 0.11 anterior tooth.
(23, 58) (43, 78) Eight children presented with oral infections at the
Age (years) 4.8 (4.5, 5.2) 4.6 (4.2, 4.9) 0.30
dmft‡ 9.1 (7.2, 11.1) 9.4 (8.0, 10.9) 0.62
12‐month follow‐up (chronic abscess); ART/HT = 3,
dt 8.2 (6.3, 10.2) 8.5 (7.2, 9.9) 0.56 DGA = 5, P > 0.05. Of the three children with
mt 0.6 (−0.1, 1.4) 0.6 (0.1, 1.2) 0.46 chronic infection in the ART/HT, one had the tooth
Ft 0.3 (0.01, 0.5) 0.3 (−0.1, 0.7) 0.43
dmfs§ 20.6 (14.8, 26.3) 18.3 (14.5, 22.1) 0.80
extracted by the ART/HT clinician, one child had
ds 17.7 (12.1, 23.3) 16.2 (12.3, 20.0) 0.82 been referred back to the OHCWA for management,
ms 2.3 (−0.8, 5.3) 1.4 (0.03, 2.8) 0.52 and one is awaiting treatment with their usual care
fs 0.6 (−0.1, 1.4) 0.7 (−0.4, 1.9) 0.43
Previous DGA Yes = 28% Yes = 15% 0.20
provider. None of the infected teeth were associated
(15, 47) (6, 33) with a crowned tooth. Of the five children in DGA
Private insurance Yes = 13% (5, 30) Yes = 9% (3, 26) 0.66 with chronic infection, three were awaiting treatment
Exam interval 12.1 (11.5, 12.6) 12.4 (11.3, 13.4) 0.57
(mths)
with their usual care provider, and two have had
†
treatment under DGA. One infected tooth was associ-
‡
One child had baseline decay experience data missing. ated with a crowned anterior tooth.
dmft = mean count of decayed, missing filled primary teeth.
§
dmfs = mean count of decayed, missing and filled primary tooth Table 4 shows the baseline characteristics between
surfaces. those children who were treated and those not trea-
ted. There were no statistically significant differences
in baseline characteristics between the groups.
The distribution of baseline characteristics of the Table 5 shows the findings with respect to the car-
study participants is shown in Table 2 and there were ies experience and restorative status for children who
no statistically significant differences in baseline values received the intended treatment as per protocol at the
between the ART/HT and DGA group. 12‐month follow‐up examination. The DGA children
Table 3 shows the caries experience overall and the had more teeth and tooth surfaces restored and the
individual components of the dmft/dmfs index at base- differences were statistically significant, P < 0.01.
line and at follow‐up, and the change in the indices for Also, more restorations in the ART/HT group were
children who had both baseline and follow‐up caries classified as failed, P < 0.01.
experience scores. The difference in the extent of Multiple logistic regression analyses controlling for
restorative treatment was not statistically significant clustering of teeth within an individual found group
between the groups, P > 0.05. The ART/HT group status was not associated with restorative failure,
162 © 2020 Australian Dental Association
 Atraumatic restorative treatments

Table 3. Caries experience and clinical outcomes of children as per intention to treat with both baseline and
follow‐up examination data
Factor ART/HT (n = 29†) DGA (n = 28)
‡ ‡
Base 12‐mth Diff (95%CI) Base 12‐mth Diff (95%CI)

dmft 9.0 9.7 0.6 (−1.3, 2.6) 9.1 9.8 0.6 (−1.0, 2.2)
dt 8.1 2.9 −5.2 (−7.3, −3.1) 8.3 3.8 −4.6 (−6.9, −2.3)
mt 0.7 2.6 1.9 (1.0, 2.8) 0.5 2.1 1.5 (0.0, 3.1)
ft 0.3 4.1 3.9 (2.9, 4.9) 0.3 3.9 3.6 (2.1, 5.2)
dmfs 20.5 34.4 13.9 (6.6, 21.2) 18.7 38.3 19.6 (13.2, 26.0)
ds 17.4 7.0 −10.4, (−4.5, −16.3) 16.4 11.7 −4.7 (−3.1, −12.5)
ms 2.4 13.1 10.7 (6.1, 15.2) 1.5 10.4 8.9 (1.7, 16.1)
fs 0.7 13.2 12.6 (8.5, 16.6) 0.8 16.0 15.2 (8.4 22.0)
§
Filling status
sound 4.0 (3.1, 5.0) 3.9 (2.2, 5.6)
fail 0.6* (0.3, 0.9) 0.1* (−0.1, 0.3)
†
One child had baseline caries experience information missing.
‡
Within group differences are statistically significant at 0.05 level when 95% CI do not contain 0.
§
Between group differences ART scores, *P < 0.01.

Table 4. Baseline characteristics of children treated

and not treated were able to test whether an alternative treatment
approach would enable comprehensive management
Factor Treated (n = 48†) Not treated (n = 17) P value of the child’s dental condition in a primary care set-
Sex Male = 46% (32, 60) Male = 65% (38, 85) 0.18 ting. The study had a low uptake from parents
Age (years) 4.6 (4.3, 5.0) 4.8 (4.3, 5.3) 0.60 approached for participation in the study, however,
dmft‡ 9.2 (7.9, 10.6) 9.5 (6.9, 12.0) 0.88 the number of participants was sufficient to meet the
dt 8.1 (6.8, 9.5) 9.0 (6.5, 11.5) 0.60
mt 0.7 (0.2, 1.3) 0.4 (−0.3, 1.2) 0.48 estimated sample size required for testing the non‐in-
ft 0.3 (0.03, 0.6) 0.1 (−0.1, 0.2) 0.31 feriority hypothesis. The large effect sizes with treat-
dmfs§ 19.5 (15.6, 23.5) 19.1 (11.6, 26.5) 0.80 ment also meant that pre‐ to post‐treatment changes
ds 16.3 (12.6, 20.1) 18.4 (10.9, 25.9) 0.56
ms 2.3 (0.1, 4.4) 0.6 (−0.3, 1.5) 0.45 were statistically significant. The pragmatic study
fs 0.9 (−0.02, 1.8) 0.7 (−0.1, 0.2) 0.31 design was a strength in being able to test the inter-
Previous Yes = 27% (16, 42) Yes = 6% (1, 37) 0.07 vention in a real‐life, publicly delivered DGA services
DGA
Private Yes = 10% (5, 23) Yes = 12% (3, 41) 0.88 for children, and its findings, therefore, are more
insurance likely to be translatable into policy and practice.37,38
Exam 12.3 (11.6, 13.0) 11.9 (10.9, 13.0) 0.55 The study approach does have its limitations, and in
interval
(mths) this instance, not all participants were provided with
†
the allocated intervention.
One child had baseline decay experience data missing.
‡
dmft = mean count of decayed, missing filled primary teeth.
Some children in the DGA arm still had not under-
§
dmfs = mean count of decayed, missing and filled primary tooth gone treatment by the time follow‐up ceased;
surfaces. 25 months after first participant recruitment. This
might have been due to the impact of external system
whilst crown restorations were protective of restora- factors such as the new children’s hospital being built
tive failure, OR = 0.05, P < 0.01 (Table 6). with the resultant relocation issues of theatre access
for DGA sessions and increased waiting times for
treatment. Treatment costs also inhibited a few from
DISCUSSION
accessing the DGA session and some sought other
To the authors’ knowledge, this is the first RCT using treatment options.
a parallel‐group comparison to evaluate alternative A related limitation also was that due to logistical
management approaches for children recommended constraints individual tooth surface status at baseline
for a DGA in a publicly‐funded dental services. was not evaluated, and thus, types of treatments pro-
Majority of the children were referred by their pri- vided in relation to the clinical status at baseline could
mary dental care provider, which suggests that stan- not be assessed. We also evaluated the restorations
dard primary care treatment was deemed using the criteria for evaluating ART restorations,
inappropriate for these children. Also, by including which might not be entirely suited for evaluating
only children for whom a specialist paediatric consul- crowns. However, our evaluation of the teeth at
tant has determined that a DGA was necessary we follow‐up with respect to occurrence of infections

© 2020 Australian Dental Association 163

P Arrow and H Forrest

Table 5. Caries experience and clinical outcomes of children who received the intended treatment with both
baseline and follow‐up examination data
†
Factor ART/HT (n = 26) DGA (n = 13)
‡ ‡
Base 12‐mth Diff (95%CI) Base 12‐mth Diff (95%CI)
§
dmft 8.7 8.9 0.2 (−1.9, 2.2) 10.6 10.7 0.5 (−1.4, 2.5)
dt 7.7 2.3 −5.4 (−7.6, −3.1) 9.2 0.4 −8.8 (−10.9, −6.6)
mt 0.8 2.4 1.6 (0.8, 2.5) 0.8 3.3 2.5 (−0.1, 5.1)
ft 0.3 4.2 3.9* (2.8, 4.9) 0.6 7.5 6.8* (4.8, 8.9)
§
dmfs 19.2 30.2 11.0* (3.9, 18.1) 22.3 48.9 26.6* (21.2, 32.0)
ds 15.8 4.2 −11.6, (−17.6, −5.6) 17.9 0.4 −17.5 (−24.9, −10.2)
ms 2.7 12.1 9.4 (5.1, 13.8) 2.6 16.5 13.9 (2.1, 25.8)
fs 0.8 12.8 12.0* (7.8, 16.2) 1.8 32 30.2* (21.4, 39.0)
§
Filling status
sound 4.0 (2.9, 5.0) 5.4 (3.0, 7.7)
fail 0.6* (0.3, 1.0) 0.1* (−0.1, 0.4)
†
One child had baseline caries experience data missing.
‡
Within group differences are statistically significant at 0.05 level when 95% CI do not contain 0.
§
Between group differences scores, *P < 0.05.

arm were successfully managed in primary care set-

Table 6. Logistic regression of restorative outcomes
controlling for group status
Odds Std. Err. P value
ratio
Group
ART/HT – ref
DGA 0.52 0.37 0.36
Restoration type
Not crown – ref crown 0.05 0.06 0.007
enabled evaluation of major failure as defined in the
evaluation of crowns. Also, the scoring used in the
evaluation of restorative status using the ART criteria
could reasonably be used to match the criteria used
for crown evaluation, such as for lost restorations vs
lost crowns, and extent of marginal discrepancies.
Although not reported, the time interval from
receipt of participant consent to treatment completion
varied greatly between the groups; the interval, on
average, was much longer in the DGA group
(32 weeks) than in the ART/HT group (14 weeks).
Children in the ART/HT group had their first treat-
ment visit within a couple of weeks of being random-
ized, but completion of treatment took longer because
treatments were provided over a number of visits.
The tooth surface condition at baseline was based
on the findings of the examining clinicians (registrars
or specialists) at the OHCWA (examined prior to ran-
domization), whilst the follow‐up assessment was
undertaken by calibrated examiners, blind to the
group allocation status. Thus, the different examiners
at baseline and follow‐up were unlikely to be a source
of bias in evaluating the clinical and restorative status
of teeth.
The two major findings of the study were; firstly,
the majority of children allocated into the ART/HT
tings, using atraumatic, minimally invasive restorative
approaches (88%). The minimally invasive approach
95% Conf. as the primary mode of restorative care also enabled
interval the undertaking of more complex treatments, such as
pulp therapy and extractions. Whilst fewer children
allocated to the DGA arm were treated as per the pro-
0.13, 2.1
tocol, within the timeframe of the study. The
0.01, 0.45 extended waiting period for care also resulted in some
children needing emergency DGA for dental extrac-
tions and for others to seek care from alternative
sources.
Secondly, a high success rate of restorative out-
comes was achieved with the ART/HT approach,
using a combination of ART and Hall crown restora-
tions. Restorative success appears to be more depen-
dent on the type of restoration (crown vs. non‐crown)
rather than the treatment approach (ART/HT or
DGA), Table 5. There was a high success rate of HT
crowns, similar to that reported elsewhere.9,12,39 The
failure rate of ART restorations (18%) found in this
study is similar to the 17% found in an earlier study
which tested the ART approach among young chil-
dren in the general community.5 Majority of the ART
restorations were multi‐surface on posterior teeth and
studies have shown the higher failure rates of GIC
restorations among multi‐surface restorations.40,41
However, the restorative failure rate is slightly lower
than other reports which evaluated restorative out-
comes after DGA over a longer period, but the success
rate for crowns was comparable.42,43 The findings
suggest that for longevity of restorations in young
children, the use of the HT should be further evalu-
ated. When analysis was undertaken of those who
received the intended treatment (Table 5), the findings
with respect to changes in the decayed and missing
teeth and decayed and missing surfaces from baseline

164 © 2020 Australian Dental Association


to follow‐up did not differ significantly between the
groups. However, the change in the number of filled
teeth and surfaces was significantly higher among the
DGA group. This was most likely as a result of more
crowns and more aggressive therapy being provided in
the DGA group.32,34
The success rate of crown restorations on primary
molars among both groups in this study was compara-
ble to success rates that have been reported.44 The
success rate of the HT was similar to that reported by
Santamaria et al among young children (mean age
5.6 years), which compared HT with conventional
restorative care for primary molars.12 In that study,
there was 98% success rate (43/44 teeth) of the HT at
the 12‐month follow‐up and 71% success rate (40/56
teeth) of the conventional treatment. The success rate
was still high after 2.5 years, 93% success of the HT
(37/40 teeth) compared with 67% success of the con-
ventional treatment (39/58 teeth).11
A non‐randomized New Zealand study, reported a
higher success rate (94%) of the HT compared with
conventional treatment (68%), after 2 years.10 That
study was implemented in a primary dental care set-
ting, with clinical care provided by dental therapists
who had been provided with additional training on
the HT. Based on the study’s findings, the authors
suggested that appropriately trained dental therapists
can successfully undertake placement of Hall crowns.
An observation supported by the findings of this
study.
A recent retrospective study evaluated the outcomes
of the HT (biological restoration) against standard
conventional treatment (comprising complete caries
removal with pulpotomy/pulpectomy where indicated)
on primary tooth, undertaken in two paediatric spe-
cialist centres.39 The authors reported that over 95%
of treated teeth in both treatment groups were deemed
successful after a median follow‐up of 13 and
9 months. The authors suggested that the biological
restorations, because of their less traumatic approach,
could reduce the number of children requiring a DGA
with potential for cost savings while reducing the
morbidity of a DGA among young children.
A commonly cited reason for a DGA among young
children is dental fear and lack of cooperation by the
child and the extent of the treatment required.45,46 In
this study, the extent of disease experience and treat-
ment required was high (the mean dmfs of a 5‐6‐year‐
old in WA was 2.5 ds = 1.247 whilst in this study the
mean dmfs = 19.4, ds = 16.9). It is also likely that the
children have been referred to the OHCWA because
of the high care need and patient behavioural manage-
ment issues. The use of the ART/HT approach
enabled the provision of timely restorative care over
multiple visits. It is likely that the minimally invasive
approach and the frequent contact with the care
© 2020 Australian Dental Association
Atraumatic restorative treatments
provider enabled the establishment of trust and confi-
dence in the provider, which facilitated the undertak-
ing of the more invasive treatments, such as pulp
therapy and dental extractions. A core component of
care delivery was the adoption of a child‐centred care
approach which met the needs of the child and the
parent. This aspect was highlighted in the qualitative
focus group interviews undertaken with study partici-
pants, which is reported in a separate paper.
A recent report also suggests that less invasive
approaches to manage childhood caries can be as
successful as the more invasive approaches.48 The
study compared best practice prevention alone, or
prevention + conventional caries management (com-
prising complete caries removal and restoration of
the prepared cavity) or prevention + a less invasive
‘biological’ approach of sealing in caries. The out-
comes evaluated were incidence of pain and/or infec-
tion over the follow‐up period. The authors
reported that there was no difference in clinical
effectiveness among the three groups with respect to
the incidence of dental pain and/or infections and
suggested that delivery of care in which a trusting
relationship was established was of importance in
achieving success.
All the children in this study were recommended for
a DGA within a publicly‐funded program and all were
eligible for free general dental care through the avail-
able government general dental services. The ART/HT
approach was able to overcome some of the system
barriers of long waiting times and direct cost of care
of a DGA.
CONCLUSIONS
DGA for the management of dental caries is usually
reserved as a last option, after all other options
have been exhausted, along a continuum of care
options. This study tested the feasibility of using
atraumatic restorative approaches to manage child-
hood caries among young children who were recom-
mended for a DGA within a publicly delivered
dental services. The findings from this study suggest
that the ART/HT approach as applied in this study
has the potential to reduce the number of children
requiring a DGA for their dental caries management
and thus, reduce the burden on publicly‐funded ter-
tiary dental services. The approach not only allowed
placement of restorations but through the establish-
ment of trust and confidence in the clinical team
enabled more invasive procedures, such as pulp ther-
apy and dental extractions, to be undertaken. This
was achieved through the adoption of child‐centred
care facilitated by the use of the less invasive and
less traumatic ART/HT approach and timely delivery
of services.
165
P Arrow and H Forrest
The findings also suggest that the ART/HT
approaches were clinically successful and that the use
of the HT can provide greater success than ART
restored teeth. Further studies with larger sample sizes
and longer follow‐ups should be undertaken to inves-
tigate factors of importance in restorative success,
including the use of the HT. Further studies are also
required to investigate the cost‐effectiveness of adopt-
ing the atraumatic restorative approach, and its
impact on child oral health‐related quality of life and
child dental fear, especially when developing dental
public health policies for this vulnerable age group.49
ACKNOWLEDGEMENTS
The authors would like to thank the parents and chil-
dren who participated in the study. We also acknowl-
edge the assistance provided by Dr Robert Anthonappa
in facilitating study participant recruitment. The study
was made possible by a research grant from the Telethon
Perth Children’s Hospital Research Fund and support of
the Dental Health Services, Western Australia.
CONFLICT OF INTEREST
The authors declare no potential conflicts of interest
with respect to the authorship and/or publication of
this article.
ETHICAL APPROVAL
Princess Margaret Hospital for Children Human
Research Ethics Committee (HREC REF 2016143EP).
Trials register (ANZCTR: ACTRN12616001124426).
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Address for correspondence:
Peter Arrow
Dental Health Services
Locked Bag 15
Bentley Delivery Centre, 6983
Perth
Western Australia.
Email: parrow@ozemail.com.au (or) peter.arrow@
adelaide.edu.au
167