692

Clinical Evaluation of the Efficacy and

Safety of a New Sonic Toothbrush
Bradley D. Johnson* and Christopher Mclnnes*

The efficacy and safety of a new sonic toothbrush were studied in this single-
blind study. The sonic toothbrush combines acoustic vibrations and dynamic fluid activity
surrounding the bristles with direct mechanical scrubbing of tooth surfaces. Fifty-one
subjects were randomly assigned to either the sonic or the manual toothbrush. Plaque
scores were assessed before and after a 2-minute brushing at baseline and 1, 2, and 4
weeks. Gingivitis and sulcular bleeding scores were also taken at each evaluation. To
assess long-term safety, 29 subjects returned after 6 months of product use. Repeated
measures analysis of variance of the total mean plaque score indicated a significant
difference between the devices over time (P < 0.01), with the sonic toothbrush dem-
onstrating a greater level of plaque removal on all tooth surfaces. On average, the plaque
reduction from the baseline score for the sonic toothbrush was 3 times greater than the
manual brush. However, when broken down by dental region, the sonic toothbrush
demonstrated an improved level of plaque removal ranging from 1.5 to 11.9 times better
than the manual brush, with the greatest improvement in the interproximal and lingual
areas. Both the gingivitis and sulcular bleeding scores exhibited a similar, significant
reduction (P < 0.005) over time for both devices with an approximate 17% decrease in
the gingivitis index and a 33% decrease in sulcular bleeding sites. Safety assessment
after 6 months of use indicated no soft tissue abnormalities which could be attributed to
the products. The results establish the safety of the sonic toothbrush and indicate that it
achieves superior plaque removal compared to a manual brush while also attaining re-
ductions in gingival inflammation similar to that achieved with the manual brush. /
Periodontol 1994;65:692-697.

Key Words: Toothbrushing/methods, toothbrushing/instrumentation; dental plaque/pre-

vention and control; gingivitis/prevention and control.

Personal oral hygiene consisting of a daily thorough re-
moval of supragingival plaque is an accepted means of
maintaining periodontal health. The importance of remov-
ing dental plaque from the tooth surface has been well sup-
ported in previous studies.13 Mechanical brushing is by far
the most prevalent method of plaque removal. Despite me-
chanical brushing, many individuals do not achieve the level
of cleaning required for sound periodontal health, as evi-
denced by the levels of gingivitis and periodontal disease
found in the population. In an attempt to assist individuals
in removing dental plaque, a variety of electrically powered
brushes have been produced. Some of these devices have
been shown to be equally effective or more effective than
manual brushing in removing supragingival plaque.4"6
However, as these brushes are typically reiterations of me-
chanical plaque removal by abrasion of the tooth surface
with the toothbrush bristles, there exists a need for a new
Department of Periodontics, University of Washington, Seattle,
*
approach to removing dental plaque and maintaining good
oral hygiene.
Recently, a new sonic toothbrush* has been developed
by the University of Washington and a commercial partner
(Fig. 1) utilizing a combination of direct mechanical plaque
removal and penetrating fluid activity beyond the bristle
tips. This sonic toothbrush operates at 520 brush strokes
per second (260 Hz) and produces acoustic vibrations in
the fluid surrounding the bristles. Similar acoustic vibra-
tions have been shown to have significant structural and
functional effects on bacteria.7 9 A significant reduction in
the ability of the oral bacteria Actinomyces viscosus to ad-
here to a model dental surface (saliva-treated hydroxyapa-
tite) was observed after exposure to acoustic vibrations.8/!.
viscosus, recognized as an early colonizer in plaque for-
mation,10 often is heavily covered with cell-surface struc-
tures that mediate attachment to the tooth surface.11 An
electron microscopic study of these bacteria showed that
WA.

Optiva Corp., Bellevue, WA. 'Sonicare, Optiva Corp., Bellevue, WA.

 Volume 65
Number 7
Figure I. The sonic toothbrush.
after exposure to the sonic toothbrush, their fimbriae were
shortened and/or removed, likely causing the observed de-
creased ability to adhere to the model surface.9 Addition-
ally, A. viscosas that had already adhered to a model dental
surface were removed due to the fluid dynamics and shear
forces associated with acoustic exposure.8 The safety of
prolonged and frequent use of this sonic toothbrush has
been recently established in a study that excessively brushed
regions of dog gingiva and teeth.12 Clinical and histological
observations showed that the excessively brushed tissue was
the healthiest with no adverse reactions noted.
The purpose of the current study was to assess the re-
duction in supragingival plaque, gingivitis, and sulcular
bleeding after brushing with the sonic toothbrush or a man-
ual brush (control). The study design was a randomized,
single-blind, controlled clinical study. Safety and long-term
compliance were evaluated with a 6-month recall of subjects.
MATERIALS AND METHODS
Fifty-three subjects were included into the study after
screening at the University of Washington's Clinical Dental
Research Center. To be accepted in the study, subjects were
required to be between 18 and 65 years of age, have a
minimum of 20 teeth, exhibit a mean Gingival Index13 of
at least 1.5 on the six Ramfjord teeth, and not have been
JOHNSON, McINNES 693
Table 1. Demographics of Subjects Completing the Study
Group
Characteristic Manual Sonic
Total subjects 23 28
Males 6 12
Females 17 16
Mean age 30.5 32.3
Age range 20 50
-
20 54
-
treated for Periodontitis within the last 24 months except
for routine tooth cleaning. Potential subjects were excluded
if they had diseases known to affect oral tissues, were
undergoing extensive dental or orthodontic treatment, had
soft tissue or carious lesions, or had manual dexterity con-
ditions that would prevent normal oral hygiene. Subjects
who chronically ingested drugs that affect the state of in-
flammation of the gingival tissues including corticosteroids,
immunosuppressives, and non-steroidal anti-inflammatory
drugs were excluded. Also excluded were subjects who had
taken systemic antibiotics in the month preceding the study
or who required antibiotic premedication prior to dental
therapy. Two of the 53 subjects were terminated during the
study as one failed to show up for 2 appointments and the
other was excluded due to a medical condition not associ-
ated with product use. Subjects missing a single visit were
retained in the study. The demographics of the subjects
completing the study are provided in Table 1.
During the initial visit, the subjects completed a medical
history form and read and signed an informed consent form
approved by the University of Washington's Human Sub-
jects Review Committee. Once accepted into the study, the
subjects were randomly assigned to one of the brushing
devices. Both groups were provided a set of brushing in-
structions prior to a demonstration of proper device usage.
Each member of the control group received a manual tooth-
brush and was instructed in the modified Bass technique.
The manual brush was selected because its head size is
comparable to that of the sonic toothbrush. Each member
of the experimental group received a sonic toothbrush and
was instructed in its use with light pressure against the tooth
surface when brushing and positioning the bristles perpen-
dicular to the tooth surface at the gingival margin. One
investigator (BJ) served as the blind examiner, making all
clinical evaluations on all subjects at each visit. Examiner
reliability was assessed on 15 of the subjects by repeated
complete mouth plaque index measurements 20 minutes
apart.
The following protocol was used at each evaluation. First,
a soft tissue examination including the gingiva, buccal mu-
cosa, lips, vestibules, palate, tongue, and floor of the mouth
was done to assess for signs of abnormalities such as abra-
sions, irritations, lacerations, or ulcérations. Secondly, a
disclosing solution was applied and the plaque score ob-
érai 30, Redwood City, CA.

694 SONIC TOOTHBRUSH EFFICACY AND SAFETY
tained for all teeth (6 sites per tooth) using an adaptation
of the Turesky Modification of the Quigley-Hein Plaque
Index14 which allowed separate scoring of proximal re-
gions. Gingival inflammation was evaluated on the Ramfjord
teeth using the Gingival Index and the Sulcular Bleeding
Index.15 The subjects then brushed for 2 minutes under the
supervision of the dental assistant with the examiner absent.
After brushing a disclosing solution was again applied to
all teeth and the plaque rescored.
Both groups were instructed to brush at home twice daily
(morning and evening) using a standard brand toothpaste11
provided with their brush. Subjects were asked to brush for
2 minutes per brushing. All subjects were provided a timer
to monitor brushing period and allow for an even brushing
distribution across the dentition. Subjects were asked not
to use other oral hygiene aids, such as floss or mouth rinses,
for the study duration. The subjects were recalled at 1, 2,
and 4 weeks for a complete evaluation as described above.
At the beginning of the visit, the subjects were questioned
about usage and compliance to the restrictions, and, before
leaving the clinic, retrained in proper brushing technique.
To assess long-term safety, the 29 subjects returned for
an evaluation after 6 months of product use (18 sonic, 11
manual). During the period between the 4-week evaluation
and the 6-month recall, subjects were asked to continue
using their device as instructed. However, they were per-
mitted to use other oral hygiene aids as desired and to see
their dentist as needed. At the 6-month recall, the soft tis-
sues were evaluated for any abnormalities or changes, in-
cluding gingival recession levels. A questionnaire was com-
pleted by all subjects to determine compliance and comments
about their brush.
A mean plaque index score was calculated for each sub-
ject for the complete dentition and for individual regions
(lingual, labial, interproximal, mid-tooth, anterior, post-
erior). The interproximal score was calculated from the av-
erage mesial and distal scores on each labial or lingual tooth
surface. Statistical analysis was accomplished using SPSS
software. A repeated measures multiple variable analysis
of variance (MANO VA) was used to assess time and device
dependent effects over all observations. Where the MAN-
OVA indicated a significant difference (P < 0.05), post-
hoc t tests were done to further examine the individual
variables of interest.
RESULTS
During the course of the study, 4 subjects from each group
missed one of the visits. As a repeated measures analysis
necessitates the removal of these subjects, their mean scores
were eliminated from the statistical analysis. Thus the final
group size for statistical analysis was 19 for the manual
= plaque score of the 1, 2, and 4 week post-brush evaluations
group and 24 for the sonic group. Calculations of the
=
mean scores with the subjects missing visits included in the
analysis increased the manual scores slightly, but had little
'Crest regular, Procter & Gamble Corp., Cincinnati, OH.
J Periodontol
July 1994
effect on the sonic toothbrush scores. With respect to intra-
examiner reliability, statistical testing of repeated plaque
evaluations showed the kappa statistic, an indication of the
agreement among examinations after adjusting for agreeing
by chance alone, was 0.56. A kappa of 0.56 suggests mod-
erate reliability,16 lower than near perfect (kappa 0.81 to
1.00) potentially due in part to the large number of readings
per subject (168 scores) leading to examiner fatigue. Mod-
erate reliability may imply that some variation in plaque
scores is due to examiner subjectivity, however, this would
be equivalent for both groups.
The mean plaque score was calculated for each subject
at each evaluation. To standardize the number of teeth used
for evaluation and to eliminate areas that were difficult to
examine, the third molars were dropped from the mean
plaque score of subjects with these teeth erupted (5 of 43).
The data were analyzed both as a complete dentition and
by oral region; e.g., anterior versus posterior, lingual ver-
sus labial, and interproximal versus mid-tooth.
The mean plaque scores at each post-brush evaluation
are shown in Table 2. Examination of both groups at base-
line showed no significant difference (P > 0.05) between
the two groups, despite the manual group exhibiting slightly
lower scores in all regions. The value reported in the
table assesses the interaction between the two devices and
all 4 time periods simultaneously. This addresses the ques-
tion of whether the two devices follow the same pattern
across time. The results indicate that for all surfaces com-
bined and all individual regions examined, the two devices
had significantly different patterns over time. Post-hoc
analysis with t tests of the "all surface" values of Table 2
indicated that the mean plaque score at weeks 1, 2, and 4
were significantly different (i > 1.96) from the initial plaque
score for the sonic toothbrush (i =
2.29, 2.86, and 1.96,
respectively) but not for the manual (t 0.78, 0.82, and
=
0. 61). As observed in the table, the greatest single period
decrease in the mean plaque score for both devices was
between the initial and one week evaluations. Beyond the
first week, the manual brush showed little or no improve-
ment in plaque scores. However, the plaque score for the
sonic toothbrush decreased further between the first and
second week evaluations, and then at the 4-week evaluation
returned to near the 1-week score.
Although the data are not shown, the mean plaque score
was calculated for each individual region of the dentition;
1. e., first separated into anterior or posterior, then divided
into labial or lingual, and finally either by interproximal or
mid-tooth surface. For illustrative purposes, the results of
this analysis are plotted in Figure 2. The plaque reduction
plotted on the vertical axis is based on the average mean
as compared to the mean plaque score from the initial post-
brush evaluation. As these data are a compilation of time
points, statistical testing was not performed. However, as
these are essentially subsets of Table 2, similar statistical
conclusions would be expected.
 Volume 65
Number 7 JOHNSON, McINNES 695

Table 2. Plaque Index at Each Post-Brushing Evaluation (Mean Score ± S.D.'

Device* Initial 1 Week 2 Week 4 Week P Value*

All surfaces
Manual 1.71 ± 0.50 1.52 0.55 1.51 0.49 1.56 0.37 0.007
Sonic 1.86 ± 0.57 1.30 0.54 1.16 0.55 1.38 0.60
AU interproximal
Manual 2.23 0.53 2.04 0.59 2.07 0.60 2.11 0.46 0.015
Sonic 2.25 0.65 1.67 0.65 1.52 0.69 1.74 0.71
All mid-tooth
Manual 1.19 0.54 1.00 0.54 0.95 0.46 1.02 0.37 0.008
Sonic 1.47 0.55 0.94 0.48 0.80 0.45 1.01 0.54
All lingual
Manual 1.76 0.59 1.64 0.65 1.65 0.62 1.65 ± 0.45 0.033
Sonic 1.90 0.56 1.47 0.61 1.35 0.59 1.55 ± 0.70
All labial
Manual 1.65 0.52 1.40 0.57 1.37 ± 0.50 1.47 0.47 0.028
Sonic 1.81 0.78 1.13 0.55 0.97 ± 0.57 1.20 0.60
All anterior
Manual 1.61 0.55 1.41 0.57 1.38 0.55 1.47 ± 0.38 0.021
Sonic 1.71 0.63 1.06 0.55 0.95 0.63 1.14 ± 0.58
All posterior
Manual 1.80 0.52 1.63 0.59 1.64 0.48 1.66 0.45 0.007
Sonic 2.01 0.64 1.55 0.61 1.37 0.58 1.62 0.72

'Manual: 19; sonic:

= 24. =

+MANOVA device by time interaction (2x4).

Table 3. Gingivitis Index (mean score ± S.D.)

Device* Initial 1 Week 2 Week 4 Week
All surfaces
Manual 1.58 ± 0.16 1.43 ± 0.19 1.29 0.15 1.28 ± 0.21
Sonic 1.47 ± 0.17 1.37 ± 0.17 1.30 0.14 1.26 ± 0.18
*Manual: =
19; sonic: =
24.

Table 4. Suicidar Bleeding Index (mean score ±S.D.)

Device* Initial 1 Week 2 Week 4 Week
I 10 All surfaces

Ell Manual 71.6

Sonic 57.5
±
±
10.3
13.6
56.7
49.2
±
±
14.9
15.9
46.6 ± 13.6
45.7 ± 13.5
45.9
40.7
±
±
16.8
14.3

'Manual: =
19; sonic: = 24.

Figure 2. Average plaque reduction for the manual and sonic toothbrushes sures analysis indicated a significant device by time inter-
separated by oral region. The reduction is based on the average mean action, however with further testing, this effect was found
plaque score of the 1, 2, and 4-week post-brush evaluations as compared to be due to a difference at baseline between the two groups.
to the mean plaque score from the initial post-brush evaluation. Mid
To adjust for the baseline differences, an analysis of co-
=

mid-tooth surface, intprx interproximal.

=

variance (ANCOVA) was utilized. The ANCOVA indi-

cated no device by time effect (P 0.26) nor a device =

The mean gingivitis score for each evaluation and device effect (P 0.26). However, there was a significant time
=

isgiven in Table 3. Statistical testing with a repeated mea- effect (P 0.004) indicating a decreased bleeding level
=

sures MANOVA indicated no device by time effect (P =

0.26), nor a device effect (P 0.26). However, there was
=
a significant time effect (P < 0.001), indicating that there
was a significant reduction in gingivitis with both devices
during the study period.
The average percentage of sites bleeding for each eval-
uation and device is given in Table 4. The repeated mea-
over the study period for both groups.
The results of the examination for gingival recession after
6 months of product use are shown in Figure 3. For the
subjects using the manual brush, 6.0% of the sites examined
exhibited recession of 0.5 mm or greater at both baseline
and 6 months. In contrast, for the sonic toothbrush users
14.1% of the sites exhibited recession at the beginning and

696 SONIC TOOTHBRUSH EFFICACY AND SAFETY
16
Baseline 6 months
Figure 3. Percentage of sites exhibiting recession of 0.5 mm or greater
at baseline and after 6 months of brushing with the sonic or manual
toothbrush.
13.7% after 6 months. There were no significant differences
in the number of sites with recession, nor in the levels of
recession for either device. Soft tissue examinations showed
7 abnormalities in 6 subjects for the manual group and 10
abnormalities in 7 subjects for the sonic group. None of
these abnormalities (e.g., cheek bite lesions, cracked lips,
or vestibular ulcérations) could be directly attributed to use
of either device.
The questionnaire and compliance report at the end of 6
months indicated none of the subjects using the sonic tooth-
brush experienced any reliability problems. Regarding
compliance, all sonic toothbrush users continued to use the
product at least once per day after the completion of the
trial, with the exception of one subject who returned to
manual brushing. No subject in the study noticed an in-
creased sensitivity in their teeth. Subjects using the manual
brush reported a mean brushing of 1.7 times/day for a pe-
riod of 1.8 minutes versus 1.8 times/day for 2.0 minutes
for the subjects using the sonic toothbrush.
DISCUSSION
The results from this investigation demonstrated that the
sonic toothbrush achieved a significantly greater level of
supragingival plaque reduction than manual brushing. Both
devices exhibited similar reductions in gingivitis and sul-
cular bleeding with time. Additionally, no safety concerns
were observed with the sonic or manual brushes over the
6-month span of the study.
Because the time between the subject's last brushing and
the evaluation appointment varied with the individual, there
was likely a greater variability in plaque buildup with the
pre-brush than the post-brush values. To reduce some of
this variability, the post-brushing evaluation was chosen for
analysis of time and device effects as shown in Table 2.
Statistical tests of the data indicated that the sonic tooth-
brush achieved a greater supragingival plaque reduction on
all surfaces of the dentition. The greatest difference be-
tween the manual and the sonic toothbrush was observed
at the 2-week evaluation. Slightly higher scores were ob-
J Periodontol
July 1994
served for the sonic and manual brush subjects at the 4-
week evaluation as compared to the 2-week, although the
differences were not statistically different. A similar in-
crease at the 4-week evaluation has been previously re-
ported with an electric toothbrush.4 In that study, it was
suggested the increase may be due in part to the 2-week
period without reinforced oral hygiene instruction and a
wearing off of the novelty effect.
The greatest reduction in plaque was observed in the first
week of brushing for both devices. This is likely due to the
subjects presenting with large amounts of plaque, some of
which may be more readily removed. Once the easiest plaque
has been dislodged, the group using the manual brush showed
no further improvement. However, the group using the sonic
toothbrush exhibited further cleaning between the 1 and 2
week time points, suggesting removal of more tenacious
dental plaque.
Further distinction between the devices was found when
the results were broken down by dental region. As Figure
2 shows, the sonic toothbrush achieved a greater plaque
reduction in all regions, especially the interproximal sur-
faces. Both the sonic toothbrush and the manual brush had
the greatest plaque reduction in the mid-tooth area of the
labial surfaces of the anterior teeth. As users typically tend
to concentrate brushing on the most visible tooth surfaces,
the greatest cleaning in this area is expected. The improved
level of plaque removal of the sonic toothbrush ranged from
1.5 times better than the manual on the mid-tooth surfaces
of the labial anterior teeth to 11.9 times better in the inter-
proximal surfaces of the lingual anterior teeth.
The improved cleaning in the interproximal areas dem-
onstrated by the sonic toothbrush may be a combination of
the shape of the bristles and the penetrating action of the
fluid surrounding the brush. The bristles on the sonic tooth-
brush are scalloped so that the span between the longest
tufts helps the bristles reach into the interproximal area.
Additionally, the sonic toothbrush produces fluid activity
that may potentially extend the reach of the cleansing ac-
tivity beyond the bristles. The improved cleaning on the
interproximal and lingual surfaces may have major clinical
significance as these are often the areas with the greatest
amount of plaque retention, and frequently exhibit the greatest
degree of periodontal breakdown.
The reduction in gingivitis and bleeding scores over the
course of the study indicate an improved level of oral hy-
giene. There appears to be, however, a lack of correlation
between the improved plaque score and the gingivitis and
bleeding scores. The subjects using the sonic toothbrush
exhibited improved supragingival plaque removal compared
to subjects using the manual brush; however, the gingivitis
and bleeding indices showed comparable improvements for
both devices. This lack of correlation has been noted in
other studies.6*17 As Khocht et al.6 have discussed, the study
requirement that subjects refrain from other oral hygiene
methods, despite prior use, may effect the observed results.
The lack of statistical difference between the devices is
Volume 65
Number 7
consistent with other reports studying improved health in-
dices after use of an electric toothbrush.6'18 Both the gin-
givitis index and the sulcular bleeding index are rather crude
measures of gingival health and do not provide fine dis-
cernment between levels of gingival health. Additionally,
the gingivitis indices may be slightly higher than actual for
both groups as slight staining of tissue may have resulted
from the disclosing solution used in the plaque index.
Safety evaluation of the devices accomplished by ques-
tioning the subjects and by visual examination of the tissue
throughout the 4-week study and 6-month recall indicated
no safety concerns. There was no indication of gingival
recession attributed to product use. About one third of the
subjects using the sonic toothbrush reported an uncomfort-
able reaction with initial product use. Typical reactions in-
cluded tenderness or a slight tickling sensation for the first
2 to 3 uses, however these subsided with continued use.
There were no abnormalities of the soft tissue which could
be attributed to brushing in either group.
in conclusion, the study demonstrated the sonic tooth-
brush's effectiveness in removing supragingival plaque and
improving gingival health. The sonic toothbrush exhibited
improved supragingival plaque removal in all regions of the
dentition when compared to manual brushing. Improved
cleaning in the interproximal areas may have the greatest
clinical benefit for the typical user. The sonic toothbrush
was shown to be safe to oral tissues throughout the 6-month
period. Given the demonstrated supragingival plaque re-
duction, use of the sonic toothbrush may lead to signifi-
cantly improved oral hygiene.
Acknowledgments
We gratefully acknowledge the clinical assistance of Ms.
Kathy Baker in this study. This study was financed by a
subcontract to the University of Washington funded by
USPHS Grant 2 R44 DE08879-02 awarded to the Optiva
Corporation, Bellevue, WA.
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Send reprint requests to: Dr. Bradley Johnson, Department of Perio-
dontics, SM-44, University of Washington, Seattle, WA 98195.
Accepted for publication December 23, 1993.