RANDOMIZED CONTROLLED TRIAL

Efficacy of 3 toothbrush treatments on plaque

removal in orthodontic patients assessed with digital
plaque imaging: A randomized controlled trial
Christina Erbe,a Malgorzata Klukowska,b Iris Tsaknaki,c Hans Timm,d Julie Grender,e and Heinrich Wehrbeinf
Mainz and Kronberg, Germany, and Mason, Ohio

Introduction: Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped
around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The
purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects.
Methods: This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period
crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and
young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based
on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating electric toothbrush with
a specially designed orthodontic brush head (Oral-B Triumph, OD17; Procter & Gamble, Cincinnati, Ohio);
(2) the same electric toothbrush handle with a regular brush head (EB25; Procter & Gamble); and (3) a
regular manual toothbrush (American Dental Association, Chicago, Ill). The primary outcome was the plaque
score change from baseline, which we determined using digital plaque image analysis. Results: Forty-five sub-
jects completed the study. The differences in mean plaque removal (95% confidence interval) between the elec-
tric toothbrush with an orthodontic brush head (6% [4.4%-7.6%]) or a regular brush head (3.8% [2.2%-5.3%]) and
the manual toothbrush were significant (P \0.001). Plaque removal with the electric toothbrush with the
orthodontic brush head was superior (2.2%; P 5 0.007) to the regular brush head. No adverse events were
seen. Conclusions: The electric toothbrush, with either brush head, demonstrated significantly greater plaque
removal over the manual brush. The orthodontic brush head was superior to the regular head. (Am J Orthod
Dentofacial Orthop 2013;143:760-6)

G
ood levels of oral hygiene are difficult to achieve
in patients with fixed orthodontic appliances
because the appliances are an obstruction to
a
Assistant professor, Department of Orthodontics, University Medical Center of
the Johannes Gutenberg-University Mainz, Mainz, Germany.
b
Clinical scientist, Global Clinical Investigations, Procter & Gamble Company,
Mason, Ohio.
c
Postgraduate student, Department of Orthodontics, University Medical Centre
of the Johannes Gutenberg-University Mainz, Mainz, Germany.
d
Clinical trial manager, Research & Development, Procter & Gamble Company,
Kronberg, Germany.
e
Senior statistician, Department of Biostatistics, Procter & Gamble Company,
Mason, Ohio.
f
Professor and head, Department of Orthodontics, University Medical Centre of
the Johannes Gutenberg-University Mainz, Mainz, Germany.
The second, fourth, and fifth authors are employees of the Procter & Gamble
Company; the study was funded by the Procter & Gamble Company.
The first, third, and sixth authors report no commercial, proprietary, or financial
interest in the products or companies described in this article.
Supported by a grant to the University Medical Centre of the Johannes
Gutenberg-University Mainz, Mainz, Germany.
Reprint requests to: Malgorzata Klukowska, P&G Mason Business Center, 8700
Mason-Montgomery Rd, Mason, OH 45040; e-mail, klukowska.m@pg.com.
Submitted, December 2010; revised and accepted, January 2013.
0889-5406/$36.00
Copyright Ó 2013 by the American Association of Orthodontists.
http://dx.doi.org/10.1016/j.ajodo.2013.03.008
760
mechanical brushing, and food readily becomes trapped
around the brackets and under the archwires. Effective
mechanical removal of plaque and accumulated food
debris throughout patients' long treatment times is
a special challenge to patients with these appliances;
and it is perhaps even more critical for them relative to
the nonorthodontic population to achieve high levels
of daily plaque removal by effective brushing to prevent
dental caries and periodontal disease.1-3
A common aim of toothbrush manufacturers is to
provide design features that can improve plaque removal
efficacy. Although an impressive array of different
models of manual and electric toothbrushes is available
for patients, a recent systematic review by the Cochrane
Collaboration demonstrated that oscillating-rotating
electric toothbrushes consistently reduced plaque more
than did manual brushes in both the short and long
terms.4,5 Most toothbrush models, and the associated
comparative clinical studies in the literature, however,
have focused on nonorthodontic populations. Since
many people in the general population have fixed
orthodontic appliances (more than 5 million in the
Erbe et al
United States in 2006 according to the American
Association of Orthodontists) and experience
difficulties in achieving high levels of plaque control,
there is an obvious need for brushes with appropriate
design features to aid in plaque removal and for these
potential advances to be assessed in comparative
clinical studies.
Assessing plaque levels in patients with orthodontic
appliances has been problematic because standard
methods are based on subjective categorical scales and
are not necessarily sensitive enough for measuring the
surface area of the plaque and its irregular accumulation
around the appliances.6-9 Recently, however, objective
area-based plaque image techniques have been developed
that offer advantages over more traditional methods.10-12
One such technique is the digital plaque imaging analysis
(DPIA) developed by Sagel et al.13 This methodology has
already been used for evaluating antiplaque chemothera-
peutics,14,15 has shown excellent reproducibility in
patients without orthodontic appliances,13 and has been
successfully adapted by Klukowska et al16 for measuring
plaque levels in patients with fixed orthodontic appliances.
The aim of this study in adolescents and young adults
with fixed orthodontic appliances was to evaluate, with
the DPIA methodology, the plaque removal efficacy of
an oscillating-rotating electric toothbrush with a spe-
cially designed orthodontic brush head compared with
a regular brush head and a regular manual toothbrush.
MATERIAL AND METHODS
To be enrolled in this study, the subjects were
required to be in good general health, at least 12 years
of age, with fixed orthodontic appliances in both arches,
and with a minimum of 8 natural front teeth with facial
scorable surfaces. All subjects enrolled in the study were
patients from the Department of Orthodontics at the
University Medical Center of the Johannes Gutenberg-
University Mainz in Mainz, Germany. The subjects
were required to have evidence of prebrushing overnight
plaque (approximately 10% plaque coverage) based on
DPIA at the screening visit. In addition, the subjects
were instructed to refrain from using nonstudy tooth-
brushes, dentifrices, mouth rinses, tooth-whitening
products, and floss for the study duration, except during
the washout periods between each visit, when they used
their usual toothbrush. The subjects also agreed not to
participate in any other oral or dental clinical study for
the duration of this study. Subjects were excluded if
there was evidence of neglected dental health.
The study, which took place in 2009, was approved
by the Freiburger Ethik-Kommission International
(Germany, code 08/2687) before the start of the trial.
Each subject and the subject's guardian gave signed
American Journal of Orthodontics and Dentofacial Orthopedics
761
informed consent, and each subject's medical history
was reviewed before study entry. Full details of the
protocol can be found by contacting the Freiburger
Ethik-Kommission International.
The DPIA system was similar to that described by
Klukowska et al.16 It consisted of a high-resolution
digital camera (digital model HC2500 3CCD; Fuji, Tokyo,
Japan) fitted with a lens (Fujinon A4 3 7.5 BMD; Fuji;
f2.8; 7.5-30 mm) with a linear polarizer to permit
cross-polarized light. A long-wave ultraviolet flash
(model FX60 fitted with cutoff filters at 265 nm; Balcar,
Rungis, France) provided the lighting. The unit was con-
nected to a computer, which recorded and analyzed the
images. Before daily use, the system was calibrated to
ensure proper operation. For each examination period,
the room was darkened to prevent reflections. Patients
disclosed their plaque with fluorescein solution by
rinsing for 10 seconds with 25 mL of phosphate buffer,
then rinsing for 1 minute with 5.0 mL of 1240 ppm
fluorescein in phosphate buffer, and then rinsing 3 times
for 10 seconds with 25 mL of phosphate buffer.
All images were captured within 2 minutes of
disclosure to minimize fluorescence variation. The
subjects were asked to place cheek retractors and to
position their chin on a chin rest in front of the camera
in a standardized way. The incisal edges of the front
teeth were slightly opened (about 2 mm) and centered
in the camera. For each subject, a digital image of the
maxillary and mandibular anterior facial tooth surfaces
was captured. The images were masked (masking
included up to 12 anterior teeth if all present, excluding
the brackets) and analyzed using Optimas software (ver-
sion 6.5.1; Media Cybernetics, Silver Spring, Md). After
that, an objective classification rule was developed
(using least squared distance pixel classification) to rec-
ognize all key elements (classes) in the image: teeth and
plaque (light and dark) on the teeth. All images in the
data base were analyzed with automated batch
classification, and the percentage of plaque coverage
on the teeth was calculated as described previously.16
This study was a replicate-use, single-brushing,
3-treatment, examiner-blind, randomized, 6-period
(visit) crossover design with washout periods of
approximately 24 hours between visits. The 3 brushes
compared in this study were the Oral-B Triumph
(oscillating-rotating action) electric toothbrush (Procter
& Gamble, Cincinnati, Ohio), with either the orthodontic
brush head (OD17) or the FlossAction regular brush
head (EB25; Procter & Gamble), and a manual
toothbrush (ADA brush; American Dental Association,
Chicago, Ill; Fig 1). Nine treatment sequences, each with
6 treatment periods (eg, ACBBCA, BACCAB, CBAABC,
ABBACC, where A, B, and C represent the 3 brush
June 2013  Vol 143  Issue 6
762
Fig 1. Study toothbrushes: A, orthodontic brush head;
B, regular brush head; C, manual brush.
46 subjects were assessed for
eligibility and enrolled
46 subjects underwent acclimation
phase
46 subjects underwent randomization 1 lost to follow-up
45 subjects were included in analysis
Fig 2. Participant flow.
treatments), determined the order in which the brushes
were assigned to the subjects for the periods in each
sequence (approximately 5 subjects per sequence). The
sequences were randomly assigned using a computer-
generated randomization plan prepared before the study.
Kits containing the treatment products were assigned by
site staff outside the view of the investigator (C.E.) to en-
sure blinding. The study sponsor and all study personnel,
except those involved in product distribution, were
blinded to treatment until the study concluded and the
data base was finalized and locked.
At an initial (acclimation) visit (visit 1), the subjects
disclosed their plaque with fluorescein as described
June 2013  Vol 143  Issue 6
Erbe et al
Table I. Baseline demographic characteristics
Age (y) Mean Range SD
14.6 12-25 2.4
Sex Frequency (n) Percentage (%)
Female 17 37
Male 29 63
Race Frequency (n) Percentage (%)
Asian Indian 1 2.2
Asian Oriental 5 10.9
White 40 86.9
Baseline DPIA Mean (%)
Power/regular 45.52
Power/orthodontic 46.45
Manual 46.08
above, and the subject's plaque level was assessed
using the DPIA. Subjects who qualified according to
the inclusion and exclusion criteria were given the
acclimation kit containing the electric toothbrush
handle, both brush heads, and a dentifrice (Blendax
Antibelag; Procter & Gamble, Gross-Gerau, Germany),
and received verbal and written brushing instructions.
Those brushing instructions were based on standard
manufacturer's brushing instructions and tailored for
patients with fixed orthodontic appliances used in the
Department of Orthodontics at the University Medical
Centre Mainz. The subjects were instructed to brush
the buccal surfaces of their teeth so that the brush could
reach the tooth area above and below the brackets. They
were told to guide the brush, slightly angled (45 angle),
slowly in the interdental space and in the spaces between
the brackets and the teeth with rotary movements of the
brush head, so that the bristles reached into these critical
areas. Then the subjects brushed using the electric
toothbrush handle, half of the mouth for 1 minute
with the orthodontic brush head (OD17) and the other
half of the mouth for another minute with the regular
brush head (EB25). During brushing with each brush,
the subjects were observed without intervention.
The subjects were instructed to use their acclimation
products at home in place of their usual toothbrush for
regular brushing (2 minutes); they were required to use
the products for approximately 4 days and to alternate
the brush heads at each brushing (morning and evening).
They were asked to switch back to their usual toothbrush
along with the acclimation toothpaste 48 hours before
the start of period 1 (visit 2). They were also asked to
continue to use their usual toothbrush and acclimation
toothpaste between treatment visits. The subjects were
also instructed to perform their last oral hygiene in the
evening (not later than 11 PM) before the day of each
scheduled afternoon study visit and asked to refrain
from eating, drinking, chewing gum, or smoking for
4 hours before their appointment time.
American Journal of Orthodontics and Dentofacial Orthopedics
Erbe et al 763

Table II. DPIA assessment: baseline and postbrushing

Postbrushing adjusted Postbrushing reduction
Baseline Postbrushing mean reduction in from baseline
Brush/brush head DPIA (%) DPIA (%)* DPIA (%) (95% CI) DPIA (%) P value
Power/regular 45.52 20.08 25.44 (22.44-28.45) 55.9 \0.001
Power/orthodontic 46.45 18.81 27.64 (24.63-30.65) 59.5 \0.001
Manual 46.08 24.41 21.67 (18.67-24.68) 47.0 \0.001

*Baseline DPIA−DPIA reduction.

crossover study should give a 2-tailed alpha of 0.05 with

Table III. Fixed effects from the statistical mixed
model
Factor Estimate (%)* (SE) 95% CI P value
Brush
Power/regular 3.8 (0.787) 2.2-5.3 \0.001
vs manual
Power/orthodontic 6.0 (0.802) 4.4-7.6 \0.001
vs manual
Power/orthodontic 2.2 (0.905) 0.6-3.8 0.007
vs power/regular
Overall baseline plaque level was 46.65%. P 5 0.252 for period;
P \0.001 for baseline plaque; P \0.001 for brush by baseline
plaque interaction.
CI, Confidence interval.
*Difference in adjusted means.
At visit 2, the subjects' plaque was disclosed as
described above, and a prebrushing DPIA image was
taken. The subjects were randomly assigned to 1 of the
9 treatment sequences and then instructed to brush (2
minutes for the electric toothbrush as described above
and 2 minutes with the modified Bass brushing
technique for the manual toothbrush following the
standard hygiene instructions for patients with fixed
orthodontic appliances used at the Department of
Orthodontics of the University Medical Centre Mainz)
with their brush (and marketed toothpaste) assigned
for that treatment period. After brushing their teeth,
the subjects redisclosed the plaque with fluorescein,
and a postbrushing DPIA image was taken. The subjects
were rescheduled for their next treatment visit and
reminded to continue to use their usual toothbrush
and acclimation toothpaste between study visits. Periods
2 through 6 (visits 3-7) had the same procedures as did
period 1. All data were collected at the Department or
Orthodontics at the University Medical Center of the
Johannes Gutenberg University Mainz.
Statistical analysis
Based on plaque removal data from a previous DPIA
orthodontic study (with a root mean squared error of
6.8), 40 completed subjects in a 3-treatment, 6-period
80% power to detect a difference between treatments of
at least 3.1%. Accordingly, approximately 45 subjects
were to be randomized into the study. All data were ana-
lyzed using SAS software (version 8.2; SAS Institute, Cary,
NC). The DPIA scores (ie, plaque levels as percentages of
tooth area coverage) were averaged on a per-subject basis
so that each subject had one DPIA score before brushing
and another score after brushing in each of the 6 treatment
periods. The difference in scores (baseline minus post-
brushing) was calculated for each subject for each treat-
ment period. These differences were analyzed for
treatment differences using a mixed model analysis of co-
variance for a crossover design with terms in the model for
subjects (random effect), treatment, period, and carryover
(potential effect from treatment used in previous period),
with the average prebrushing (baseline) score as the covar-
iate. Since the carryover term was not significant (P 5
0.291), the final crossover model did not include the car-
ryover term. The adjusted mean plaque removal scores for
each treatment were also analyzed for statistical signifi-
cance from zero using a t test on the adjusted treatment
mean score differences from the analysis of covariance.
Treatment comparisons were 2 sided, and all statistical
tests had a significance level of 0.05.
RESULTS
A total of 46 subjects were enrolled and randomized
into 1 of the 9 treatment sequences. One subject was lost
to follow-up before the second study visit, and 45 sub-
jects completed the study. See Figure 2 for participant
flow. Baseline demographics for each group are shown
in Table I.
The average baseline (prebrushing) DPIA score,
the mean postbrushing DPIA score, and the mean DPIA
reduction for each treatment are presented in Table II.
Additionally, the P value corresponding to a statistical
reduction is included for each brush. The DPIA scores
for the 3 brush treatments did not differ significantly
from each other at baseline (P 5 0.856), with each group
having an average baseline plaque level over 45%. All 3
treatments showed statistically significant postbaseline

American Journal of Orthodontics and Dentofacial Orthopedics June 2013  Vol 143  Issue 6
764
Fig 3. Prebrushing and postbrushing images of the same subject for each of the 3 treatment groups.
plaque reductions, ranging from 47% (manual) to 59.5%
(electric with orthodontic brush head).
Table III shows the estimates and confidence intervals
for brush effects and the P values for all variables in the
final statistical model. Both the electric toothbrush with
a regular brush head and the electric toothbrush with an
orthodontic brush head showed statistically significantly
greater amounts of plaque removal by 3.8% and 6.0%,
respectively (both, P \0.001), compared with the
manual brush. This resulted in a 17.4% advantage for
the electric toothbrush with a regular brush head and
a 27.5% advantage for the electric toothbrush with an
orthodontic brush head vs the manual brush. A
comparison between the 2 electric brush heads showed
that the orthodontic brush head removed statistically
significantly more plaque than did the regular brush
head (by 2.2%; P 5 0.007) resulting in 8.6% more
plaque removal than the regular one.
Figure 3 shows images of a subject before and after
brushing with the 3 brush treatments. Visual assessment
of plaque images showed that the electric toothbrush
with the standard and orthodontic brush heads had
advantages relative to the manual brush, predominantly
along the gum line and around the bracket area. In
general, plaque removal was less effective in subjects
with smaller tooth areas or with additional orthodontic
constructions.
No adverse events were seen in this study.
June 2013  Vol 143  Issue 6 American Journal of Orthodontics and Dentofacial Orthopedics
Erbe et al
DISCUSSION
This study was a replicate-use, single-brushing
design, and the subjects were adolescents and young
adults (ages, 12-25 years) with multibracket appli-
ances in both arches. The DPIA methodology showed
high average levels of baseline plaque (over 45%) for
each of the 3 treatments (Oral-B Triumph electric
brush, with either an orthodontic brush head or
a regular brush head, and a regular manual tooth-
brush). Plaque removal with the power toothbrush,
with either an orthodontic brush head (59.5%) or
a regular brush head (55.9%), was statistically superior
(P \0.001) to that with the manual toothbrush (47%),
and plaque removal with the power brush and ortho-
dontic brush head combination was statistically supe-
rior (P \0.01) to the power brush and regular brush
head combination.
A potential limitation of the trial was its short
duration. Long-term comparative clinical studies are
desirable for assessing the relative effectiveness of
various brushes for the prevention of dental caries and
gingivitis; however, running clinical studies over many
months presents practical difficulties. In subjects
without orthodontic appliances, the results of short-
term (single-use) comparative plaque removal studies
have been shown to give a good indication of potential
long-term benefits.17-20 Likewise, single-use studies
Erbe et al
in subjects with orthodontic appliances can be expected
to be meaningful, but the outcome of these studies
might depend crucially on the design of the trial, which
includes having a means of quantifying plaque that is
appropriate for this subject population. This study
involved a replicate-use, single-brushing, crossover
design, with each product used twice by each subject
according to 1 of 9 treatment sequences. Although
crossover studies have the potential for carryover and
period effects, the design of this trial accounted for
carryover and period effects, neither of which were
confounded with the estimation of treatment effects in
this 3-treatment, 6-period design. Additionally, carry-
over effects were not significant and were removed
from the final crossover model. The design used the
objective DPIA method, which has been shown to be
appropriate for orthodontic patients by Klukowska
et al.16 Image analysis appears to offer a method of
plaque measurement that is more sensitive and accurate
than the more traditional subjective indexes that use
scales and, as demonstrated in our study, provides
a convenient quantitative technique for making a clinical
comparison between the plaque-removal effectiveness
of different brushes in patients with fixed orthodontic
appliances.6-9 It can be discussed whether the
effectiveness of plaque removal on anterior teeth can
be transferred to posterior teeth. Research correlating
whole-mouth vs anterior plaque reduction has shown
that partial-mouth plaque grading is comparable
with whole-mouth plaque scores using the Turesky
modified Quigley-Hein index (intraclass correlation
coeffient, 0.743).21
Removing plaque around brackets and archwires is
notoriously challenging for patients, as evidenced by
the high baseline plaque values in this trial (.45%)
and other research.16,22 These results indicate that use
of an electric toothbrush, specifically with an
orthodontic brush head, can improve plaque control in
the broader population of orthodontic patients with
fixed appliances. The inclusion criteria were typical of
healthy patients aged 12 or older with fixed
orthodontic appliances, and the high baseline plaque
coverage in this trial was consistent with epidemiologic
research measuring orthodontic patients' plaque
levels.16 Furthermore, the power toothbrush and brush
heads tested in this trial are readily available in most
countries.
Compared with the regular brush head and the
manual tooth brush, the design of the orthodontic brush
head, consisting of an irregular contour and a smaller
head, aims for a better adaptation of the brush head
required by the specific surfaces of teeth with fixed
orthodontic appliances. The orthodontic brush head
American Journal of Orthodontics and Dentofacial Orthopedics
765
gives improved coverage of the brackets and achieves
better cleaning for interdental spaces and along the
gum line. Although the objective of this trial was not
to quantify the distribution of plaque among each
treatment group, visual assessments showed advantages
for the standard and orthodontic brush heads over the
manual brush, with the difference primarily noted
around brackets and along the gingival margins.
Patients with smaller tooth surfaces and additional
orthodontic constructions had less effective plaque
removal in all groups.
This comparison of plaque removal effectiveness,
which showed advantages for the oscillating-rotating
electric toothbrush, is consistent with other reports in
the literature among the representative population. A
systematic review of clinical studies comparing manual
vs electric toothbrushing conducted by the Cochrane
Collaboration found that oscillating-rotating electric
toothbrushes consistently reduced plaque more than
did manual brushes in both the short and long terms.4,5
Furthermore, the effectiveness of the advanced electric
toothbrush used in this study (Oral-B Triumph) has
been shown to have advantages over sonic power
models.23,24 Although it is always challenging to
make conclusions about clinical significance among
treatments from the results of a single trial, our
results along with those of published research should
be considered by clinicians when giving home
hygiene recommendations to patients. A longer trial
could be considered to further substantiate the
efficacy of the brushes not only on plaque removal,
but also on their effects on gingival health of
orthodontic patients.
CONCLUSIONS
This study in subjects with multibracket appliances
demonstrated, by using digital imaging technology,
the plaque-removing superiority of an oscillating-
rotating electric brush over a manual brush, and of an
orthodontic brush head over a regular brush head. The
imaging analysis is a sensitive and convenient way for
clinically measuring and comparing plaque removal
effectiveness of oral hygiene devices in an orthodontic
population.
We thank Jane Mitchell (Medical Writing Services,
United Kingdom) and Lisa Sagel for assistance with the
manuscript and Philip Bellamy and Robin Harris for their
assistance in imaging analysis.
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