journal of prosthodontic research 60 (2016) 185–192

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Original article

Comparison of patient-reported outcomes between

immediately and conventionally loaded
mandibular two-implant overdentures:
A preliminary study§
Yuri Omura DDSa, Manabu Kanazawa DDS, PhDa,*,
Daisuke Sato DDS, PhDb, Shohei Kasugai DDS, PhDc,
Shunsuke Minakuchi DDS, PhDa
a
Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and
Dental University (TMDU), Tokyo, Japan
b
Department of Implant Dentistry, School of Dentistry, Showa University, Tokyo, Japan
c
Oral Implantology and Regenerative Dental Medicine, Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University (TMDU), Tokyo, Japan

article info abstract

Article history: Purpose: The aim of this preliminary study is to compare patient-reported outcomes be-
Received 16 September 2015 tween immediately and conventionally loaded mandibular two-implant overdentures
Received in revised form retained by magnetic attachments.
14 December 2015 Methods: Nineteen participants with edentulous mandibles were randomly assigned into
Accepted 28 December 2015 either an immediate loading group (immediate group) or a conventional loading group
Available online 21 January 2016 (conventional group). Each participant received 2 implants in the inter-foraminal region
by means of flapless surgery. Prostheses in the immediate and conventional groups were
Keywords: loaded using magnetic attachments on the same day as implant placement or 3 months after
Immediate loading surgery, respectively. All participants completed questionnaires (the Japanese version of the
Implant Oral Health Impact Profile for edentulous [OHIP-EDENT-J], the patient’s denture assessment
Mandibular overdenture [PDA], and general satisfaction) before implant placement (baseline) and 1, 2, 3, 4, 5, 6, and 12
Patient-reported outcome months after surgery. The median differences between baseline and each monthly score
Quality of life were compared using the Mann–Whitney U test. The differences in median and 95%
confidence interval between two groups were analyzed.
Results: The immediate group showed slightly lower OHIP-EDENT-J summary score at 1 and
3 months than the conventional group (P = 0.09). In the lower denture domain of PDA, the
immediate group showed a statistically higher score at 3 months (P = 0.04). There was no
statistically significant difference in general satisfaction between the two groups.

§
The clinical trial registration number: UMIN000009889.
* Corresponding author at: Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and
Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan. Tel.: +81 3 5803 5563; fax: +81 3 5803 5586.
E-mail address: m.kanazawa.gerd@tmd.ac.jp (M. Kanazawa).
http://dx.doi.org/10.1016/j.jpor.2015.12.010
1883-1958/# 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
186 journal of prosthodontic research 60 (2016) 185–192

Conclusions: Based on this preliminary study, immediate loading of mandibular two-im-

plant overdentures with magnetic attachments tends to improve oral health-related quality
of life and patient assessment earlier than observed with a conventional loading protocol.
# 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. This is an open access article
under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction 2. Materials and methods

Implant overdentures (IOD) have improved the clinician’s
ability to successfully treat edentulous patients. Several
studies have shown that IOD provide adequate denture
stability and retention and improve patients’ quality of life
(QoL) and lead to higher denture satisfaction, including
better function, speech, and comfort [1,2]. The McGill
consensus suggested that a two-implant overdenture
(2-IOD) should become the first choice of treatment for the
edentulous mandible [3]. According to the Brånemark
protocol, a 3–6-month healing period should be incorporated
after implant placement to achieve osseointegration [4]. The
long healing period might impose aesthetic, functional,
psychological and socially intolerable consequences for
edentulous patients [5]. In the original implant placement
protocols, a mucosal flap was commonly elevated to better
visualize the implant recipient sites despite postoperative
morbidity and discomfort [6]. In contrast, flapless surgery
reduces surgical invasiveness and an immediate loading
protocol permits denture use on the same day as implant
placement.
Immediate loading of IOD treatment has been attempted
to shorten the healing period and to allow earlier use of
dentures. Several studies have reported that the immediate
loading of 4-IOD and 2-IOD splinted by bar attachments lead
to a high implant success rate [7–10]. In recent years, several
pre–post studies without control groups have reported that
immediate loading of 2-IOD with non-splinted attachments
achieves preferable results [11–16]. In addition, three
randomized clinical trials compared immediate loading of
2-IOD retained by ball attachments [17,18] and locator
attachments [19] with conventional loading. Although,
implants in the immediate group showed lower survival
rate than seen in the conventional groups, the difference
was not statistically significant. In addition, with regard to
retention mechanisms, magnetic attachments appear to
reduce lateral force to the implants. Implant survival rates,
marginal bone resorption and peri-implant tissue responses
with immediate loading 2-IOD have been evaluated [11–16].
However there are no randomized clinical trials comparing
patient reported outcomes (PROs) after immediate loading of
2-IOD retained by magnetic attachments to 2-IOD retained
in similar fashion and utilizing a conventional loading
protocol.
The aim of this study is to compare PROs of immediately-
and conventionally-loaded mandibular 2-IOD retained by
magnetic attachments. The null hypothesis was that there
would be no differences in the oral health-related quality of
life (OHRQoL) between immediately- and conventionally-
loaded mandibular 2-IOD.
2.1. Trial design
This study was a randomized unblinded parallel-group trial to
compare the PROs of immediately loaded mandibular 2-IODs
retained by magnetic attachments with those of convention-
ally loaded mandibular 2-IODs.
All participants were given oral and written information
about the study and signed informed consent forms. The
Ethics Committee at Faculty of Dentistry, Tokyo Medical and
Dental University approved the study protocol (Number 693).
Participants had to meet the following inclusion criteria: (1) a
completely edentulous mandible and any opposing maxillary
remaining tooth condition, (2) adequate bone volume in the
anterior mandible for placement of 2 implants with a
minimum dimension of 4.0  10.0 mm, (3) no need for bone
augmentation, (4) willing to wait at least 4 months of healing
after extraction, (5) good oral hygiene, and (6) possession of
an adequate understanding of written and spoken Japanese
to respond to our questionnaires. The exclusion criteria for
the patients included the following: (1) uncontrolled system-
ic disease that might compromise implant surgery, (2) a
history of chemotherapy or radiotherapy to the head and
neck region, (3) heavy smokers, and (4) a history of
bisphosphonate administration. Participants were randomly
assigned equally into two groups: the immediate loading
group (immediate group) and the conventional loading group
(conventional group). Randomized treatment allocation of
participants was executed by the minimization method to
ensure pretreatment comparability of the groups with
respect to age, gender and the American College of
Prosthodontists (ACP) classification [20]. As there were no
previous studies comparing PROs of these two loading
protocols, a sample size of 10 participants per group was
chosen for this preliminary study.
2.2. Surgical and prosthetic procedures
Panoramic radiographs were utilizes for preoperative clinical
assessment of each mandible. Each participant received new
mandibular complete dentures or had their existing mandib-
ular complete dentures relined to improve the denture fitting
before implant placement. All participants were treated
following a previously described protocol including computed
tomography (CT) scans, preoperative planning, manufactur-
ing of surgical guides and implant placement procedures
[21,22]. Two implants (Nobel Speedy Groovy RP w4  10–
18 mm, Nobel Biocare, Gothenburg, Sweden) were inserted
in the inter-foraminal area of each participant according to the
manufacturer’s protocol for a flapless surgical procedure [23].
 journal of prosthodontic research 60 (2016) 185–192
Fig. 1 – Outline of study design. T0; baseline, Ti; evaluation periods of OHIP-EDENT-J, PDA and satisfaction. i; 1, 2, 3, 4, 5, 6, and 12
months after implant placement. Implants in the immediate and conventional groups were loaded with magnetic attachments
retaining mandibular overdentures on the same day of implant placement and or after evaluation at T3, respectively.
The same implantologist, who was associated with Dental
Hospital Tokyo Medical and Dental University (TMDU), placed
all the implants.
In the immediate group, a keeper (Magfit, Aichi Steel Co.,
Aichi, Japan) with a diameter of 4.7 mm and the appropriate
height (3.0, 4.0 or 5.5 mm) was selected according to the
thickness of the soft tissue and connected to each implant
using a torque of 25–30 Ncm. Following, magnetic assemblies
(Magfit, Aichi Steel Co., Aichi, Japan) were incorporated into
the intaglio surface of the dentures intra-orally with autopo-
lymerizing acrylic resin (Unifast III, GC, Tokyo, Japan).
Participants were instructed to wear their denture for 24 h
to minimize postoperative swelling and prevent the dentures
from being maladapted. Participants were instructed not to
remove their denture during the first week except for denture
cleaning and oral hygiene.
In the conventional group, two healing abutments were
connected to the implants. The inner aspects of the denture
base around the healing abutments were relieved so that
contact of the denture with the abutments was minimized to
abrogate placing stress on the implants. Three months after
surgery, the healing abutments were replaced with keepers of
the appropriate height and magnetic assemblies picked up in
the same way as described for the immediate group.
Postoperatively, for all participants antibiotics (750-mg
amoxicillin per day) for 7 days and analgesics (60-mg
loxoprofen) were prescribed. Participants were instructed to
rinse with 0.2% benzethonium chloride solution 3 times per
day for 2 weeks and to start brushing the individual implant
attachments 1 week after surgery. No food restrictions were
given to participants.
2.3. Outcomes
PROs were comprised of 3 questionnaires: the Japanese
version of the Oral Health Impact Profile for edentulous
(OHIP-EDENT-J) [24] as a primary outcome, a questionnaire
regarding patient’s self-assessment of dentures (the patient’s
denture assessment; PDA) [25,26], and a general satisfaction
questionnaire as secondary outcomes.
The OHIP-EDENT-J assesses oral health related QoL of
edentulous patients. It includes 19 items answerable on a
187
five-point Likert scale ranging from 0 (never) to 4 (very often)
and provides a summary score ranging from 0 to 76. The lower
score indicates a better QoL. Although the OHIP was originally
composed of seven domains, this structure has been rejected
in some investigations. In the recent studies, the concept of
four dimensions is suggested. The use of total scores indicated
that researchers considered OHRQoL summarized by one
score as meaningful [27,28]. In this study, the summary score
was analyzed.
PDA assesses the impacts of removable denture treatment
on a patient’s perceptions, consciousness, and feelings about
his/her dentures multilaterally. This questionnaire focuses on
each domain than summary score in contrast to OHIP. We
analyzed three domains of the PDA: ‘function’, ‘lower
denture’, and ‘aesthetics and speech’. Each question item
was measured using a 100-mm visual analogue scale (VAS).
Higher score indicates patients have evaluated the denture as
better.
To assess general satisfaction with their dentures, parti-
cipants were asked to rate their current prostheses on a 100-
mm VAS ranging from 0 (completely dissatisfied) to 100
(completely satisfied). The VAS question was stated as ‘‘how
satisfied are you with your prosthesis?’’ A higher score
indicates greater satisfaction.
An outline of this study describing the allocation, each
evaluation period, and the timing of magnetic attachment
connections is presented in Fig. 1. All participants completed
the questionnaires before implant placement (baseline) and at
1, 2, 3, 4, 5, 6, and 12 months after implant placement. All
surgical and prosthetic complications were recorded. An
implant failure was recorded if there was pain on function,
mobility, radiographic bone loss along more than half of the
length of the implant, uncontrolled exudate, or loss of the
implant [29]. One evaluator performed all the clinical data
collections at Prosthodontics department of the Dental
Hospital TMDU.
2.4. Statistical analysis
Medians and 95% confidence intervals of all data groups of the
OHIP-EDENT-J summary score, the three domains of PDA,
and the general satisfaction questionnaire were calculated.
188 journal of prosthodontic research 60 (2016) 185–192
Fig. 2 – Flow of participants during study.
Median differences between baseline scores and each month-
ly score of the immediate and conventional groups were
compared using the Mann–Whitney U test. Difference in
medians between two groups at baseline and each monthly
evaluation period were also analyzed. In addition, the baseline
characteristics of the participants in both groups were
compared using non-paired t-test and chi-square test. All
statistical analyses were performed using statistical software
(IBM SPSS Statistics 22, Chicago, IL, USA). Statistical signifi-
cance for all the tests was set at P < 0.05.
3. Results
The flow of participants through this randomized clinical trial
is shown in Fig. 2. Twenty-three edentulous participants were
recruited in this clinical trial. We excluded 4 participants who
did not meet the inclusion criteria. Of the excluded partici-
pants, 1 had uncontrolled diabetes, 1 was in poor health and 2
were too busy to attend treatment and follow-up appoint-
ments. Therefore, 19 participants (9 males and 10 females)
with a mean age of 68.4 years (range 46–86 years) were enrolled
in this study during the 2012–2013 time period. Baseline
summary characteristics of the participants are listed in Table
1. There were no significant differences in age, gender or ACP
classification between the two groups. One participant in the
conventional group who lost both implants 1 month after the
surgery was excluded from analysis. No implants were
retrieved in the immediate group. Therefore, data from 10
and 8 participants in the immediate and conventional groups,
respectively, were analyzed.
Medians baseline OHIP-EDENT-J summary scores, the three
domain scores of the PDA, and the general satisfaction scores
are presented in Table 2. Median differences of OHIP-EDENT-J
between baseline and each monthly evaluation period, and
differences in medians between two groups at baseline and
each evaluation period are presented in Table 3. The summary
scores in the immediate group were slightly lower than in the
conventional group at 1 and 3 months (P = 0.09 and 0.09,
respectively). The differences between two groups were about
6 points. The differences in medians of PDA between two
groups are presented in Table 4. The lower denture score in the
immediate group was slightly higher at 1 month (P = 0.08) and
statistically significantly higher at 3 months than the
conventional group (P = 0.04). The differences between two
groups were 27, 31 points respectively. There were no
significant differences in the other domains of PDA. The
differences in medians of general satisfactions between two
groups are presented in Table 5. Regarding general satisfac-
tion, there were no statistically significant differences be-
tween two loading protocols.
4. Discussion
This 12-month preliminary study compared PROs of man-
dibular edentulous participants in an immediately loaded
protocol group with those in a conventionally loaded
protocol group. Improvement trends in the OHIP summary
score was observed earlier in the immediate group than in
the conventional group. The results of OHIP score might be
influenced by small sample sizes [27]. It is proposed that OHIP
was characterized by four dimensions [27,28]. This pilot
study used summary score for analysis to avoid an error
and the complexity of the result because sample size was
small.
 journal of prosthodontic research 60 (2016) 185–192 189

Table 1 – Baseline characteristics of participants in both groups.

Characteristics Total (n = 19) Immediate group (n = 10) Conventional group (n = 9) P
Age, mean (SD) (years) 68.4 (9.9) 69.2 (10.6) 66.6 (9.1) 0.57*
Gender (male/female) 9/10 6/4 3/6 0.25y
ACP classification 0.89y
I 4 2 2
II 5 3 2
III 7 4 3
IV 3 1 2
*
Based on non-paired t-test.
y
Based on chi-square test.
There were no statistically significant differences between two groups.

Table 2 – Baseline scores of OHIP-EDENT-J, PDA and satisfaction in both groups.

Immediate group Conventional group P
Median (IQR) Median (IQR)
OHIP-EDENT-J
Summary score 22 (13, 27) 20 (12, 25) 0.56
PDA
Function 82 (75, 89) 84 (60, 87) 0.79
Lower denture 51 (35, 72) 38 (35, 65) 0.72
Aesthetics and speech 77 (55, 89) 64 (50, 78) 0.50
Satisfaction 73 (43, 83) 57 (52, 95) 1.00
IQR, interquartile range.
Mann–Whitney U test. There were no statistically significant differences between two groups.

Table 3 – Median differences of OHIP-EDENT-J between baseline and each monthly evaluation period, and differences in
median between two groups (95% confidence interval).
Median differences (95% confidence interval) of OHIP-EDENT-J scores

T1–T0 T2–T0 T3–T0 T4–T0 T5–T0 T6–T0 T12–T0

Summary score
Immediate 3 (12, 2) 2 (10, 6) 5 (13, 2) 3 (12, 3) 5 (15, 1) 3 (14, 2) 8 (20, 0)
Conventional 4 (4, 8) 2 (5, 7) 2 (1, 3) 4 (10, 3) 2 (10, 5) 3 (11, 3) 5 (17, 1)
Difference in medians 6 (16, 2) 3 (10, 7) 6 (15, 2) 0.5 (12, 9) 4.5 (16, 6) 1 (15, 7) 0 (13, 9)
P 0.09 0.40 0.09 0.97 0.33 0.93 0.93
T0: Baseline score, Ti: i = 1–6, 12 months after implant placement. Ti–T0: the difference between T0 and Ti.
Mann–Whitney U test. There were no statistically significant differences between two groups.

No statistically significant differences in OHIP scores
between the two groups were seen at any time period of the
study relative to baseline. Nevertheless, the OHIP summary
score in the immediate group median score decreased
(representing in improvement in QoL) and that in the
conventional group showed the opposite trend that increased
(representing a worsening of QoL) until three months after
implant placements, the large confidence interval and small
sample size precluded statistical significance being observed.
Three months after surgery, there was a statistical
difference in the lower denture assessment of PDA between
the two groups (P = 0.04). The most likely cause for this
difference is the fact that the immediate group has enjoyed a
retentive prosthesis since surgery while the conventional
group has not. As a result of OHIP, it may have influence on
their denture assessments that the participants in the
immediate group felt few pains after surgery. In addition,
the height of the healing abutments still in place in the
conventional group led to some dentures being thin and
fracturing during the healing period and in some cases [30],
healing abutments came loose and initiated mucosal discom-
fort. These factors may have caused the two groups to have
significantly different median scores in denture satisfaction.
Four months after implant placement, the QoL and denture
assessments in the conventional group showed improve-
ments. In general, the PROs scores of participants in the
conventional group ‘‘caught up’’ to the scores of participants
in the immediate group. By exchanging healing abutments for
magnetic attachments, denture stability and retention im-
proved.
The general satisfaction in the immediate group showed a
tendency to improve after implant placement though there
were no statistically significant differences between the
groups. Interestingly, some participants complained about
their maxillary dentures even when they reported satisfaction
with their 2-IODs, which may have impacted their general
satisfaction score and limited the magnitude of the expected
increase in satisfaction scores of immediate group. Satisfac-
tion with treatment is a highly complex phenomenon affected
by numerous factors, not only the stomatognathic system [31].
190 journal of prosthodontic research 60 (2016) 185–192

Table 4 – Median differences of PDA between baseline and each monthly evaluation period, and differences in median
between two groups (95% confidence interval).
Median differences (95% confidence interval) of PDA scores

T1–T0 T2–T0 T3–T0 T4–T0 T5–T0 T6–T0 T12–T0

Function
Immediate 7 (12, 18) 12 (1, 16) 6 (3, 14) 10 (1, 18) 9 (5, 16) 10 (5, 15) 10 (2, 21)
Conventional 7 (12, 15) 8 (10, 22) 9 (15, 20) 14 (8, 30) 14 (2, 25) 14 (1, 31) 14 (3, 29)
Difference in medians 2 (12, 17) 2 (15, 19) 0.5 (13, 15) 4.5 (24, 21) 3 (17, 14) 4.5 (23, 10) 4.5 (18, 13)
P 0.69 0.59 0.89 0.66 0.82 0.51 0.53
Lower denture
Immediate 24 (4, 39) 26 (7, 41) 26 (4, 47) 27 (7, 46) 26 (8, 43) 28 (10, 42) 34 (14, 45)
Conventional 3 (23, 18) 12 (6, 26) 0 (27, 18) 27 (12, 43) 27 (16, 40) 33 (11, 52) 44 (21, 61)
Difference in medians 27 (3, 49) 13 (12, 39) 31 (1, 63) 1 (23, 20) 2 (23, 20) 6 (30, 18) 12 (38, 15)
P 0.08 0.16 0.04* 0.93 0.76 0.66 0.25
Aesthetics and speech
Immediate 13 (1, 23) 17 (2, 26) 12 (1, 23) 15 (3, 25) 16 (3, 24) 15 (3, 25) 17 (5, 29)
Conventional 5 (7, 33) 3 (12, 37) 11 (2, 33) 17 (2, 41) 18 (4, 35) 19 (6, 42) 29 (12, 49)
Difference in medians 3.5 (24, 20) 6 (21, 29) 1 (21, 14) 6 (29, 15) 5.5 (25, 12) 6.5 (31, 12) 12 (36, 9)
P 0.72 0.69 0.79 0.48 0.53 0.33 0.18
T0: Baseline score, Ti: i = 1–6, 12 months after implant placement. Ti–T0: the difference between T0 and Ti.
Mann–Whitney U test.
*
P < 0.05.

Table 5 – Median difference of satisfaction scores between baseline and each of monthly evaluation period, and
differences in median between two groups (95% confidence interval).
Median differences (95% confidence interval) of satisfaction scores

T1–T0 T2–T0 T3–T0 T4–T0 T5–T0 T6–T0 T12–T0

Satisfaction
Immediate 14 (3, 26) 15 (2, 25) 14 (2, 28) 13 (3, 23) 17 (6, 28) 15 (3, 35) 19 (9, 45)
Conventional 0 (16, 33) 1 (16, 30) 16 (1, 32) 13 (4, 46) 11 (1, 37) 2 (13, 39) 31 (6, 56)
Difference in medians 6.5 (21, 32) 11.5 (9, 28) 0 (25, 20) 7.5 (36, 15) 1.5 (24, 22) 9.5 (20, 33) 0.5 (34, 19)
P 0.53 0.17 1.00 0.56 0.76 0.40 0.97
T0: Baseline score, Ti: i = 1–6, 12 months after implant placement. Ti–T0: the difference between baseline score and each evaluation period
score.
Mann–Whitney U test. There were no statistically significant differences between two groups.

It is affected by not only mandibular dentures but also
maxillary dentures, and the expectation for the treatment.
Improved stability and retention of the mandibular prosthesis
may alter the patient’s perception of the maxillary prosthesis
[32]. In addition, it is said that magnetic attachments showed
smaller retentive force and lower patient satisfaction com-
pared with other attachment systems such as bar and ball
attachments [33].
Overall, there are limitations to the PROs instruments used
in this study even though they are widely-utilized in clinical
research and have been extensively validated. Specifically, the
OHIP summary score was already low at baseline and it might
have been susceptible to a ‘‘floor effect’’. Furthermore, it is
important to recognize that OHIP is designed to capture only
negative impacts and is not designed to detect positive
changes in patients who have no or few negative impacts at
baseline [34]. In contrast, the function domain scores of the
PDA were already high before implant placement in both
groups. The fact that no statistically significant difference was
detected between the two groups is likely due to a ‘‘ceiling
effect’’. It is not surprising that the median scores of the
aesthetics domain of the PDA were similar as the denture form
and physical appearance did not change because of the
difference in loading protocol [31]. The general satisfaction
also might be influenced by the ceiling effects. Further, the
Hawthorne effect was likely, and unavoidably, encountered
simply by the intervention of implant placement [35].
The present study has other limitations such as a small
sample size with low statistical power, a follow-up period on
1-year. In this study, a comparison of PROs in immediate and
conventional loading groups receiving mandibular implant
overdentures were conducted which had not been reported
previously. The two groups were defined by whether or not
they had a healing period. Therefore, the evaluation period
was set to include monthly observation intervals in an
attempt to capture differences during the first six-month
period. Since no statistically significant differences were
observed between the two groups, the null hypothesis is
accepted. In future studies, a more comprehensive evaluation
of the two protocols in terms of implant survival rates,
marginal bone changes, complications, and cost-effective-
ness are indicated. Furthermore, it is necessary to confirm the
findings of this study over a longer duration and with a larger
sample size.
 journal of prosthodontic research 60 (2016) 185–192
5. Conclusion
Within the limitations of this preliminary 12-month study,
immediate loading of mandibular two-implant overdentures
with magnetic attachments is a viable treatment option for
patients diagnosed with mandibular edentulism. The results
indicate that an immediate loading protocol tends to improve
OHRQoL of mandibular overdenture wearers sooner than that
observed with a conventional loading protocol.
Conflict of interest statement
There are no conflicts of interest associated with this study.
Acknowledgement
This work was supported by JSPS KAKENHI Grant Number
25462986.
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