Beruflich Dokumente
Kultur Dokumente
770
Six-Month Comparison of Powered Versus
Manual Toothbrushing for Safety and
Efcacy in the Absence of Professional
Instruction in Mechanical Plaque Control
Andrew R. Dentino,* Gay Derderian,* MaryAnn Wolf,* MaryAnn Cugini,
Randy Johnson,
Pam Marks,
Background: Reports suggest powered toothbrushing may provide some clinical benet over manual tooth-
brushing, but most studies have been of short duration with subjects trained in toothbrush use. The aim was
to determine if the oscillating-rotating powered brush (PB) could safely provide clinical benets over and above
a manual brush (M) in subjects with no formal instruction or experience in powered brush use.
Methods: This 6-month, single-masked, parallel design, randomized clinical trial compared the PB with an
American Dental Association (ADA)-accepted soft-bristle manual brush in a non-ossing gingivitis population
(n = 157). Subjects were given written instructions but no demonstration on toothbrush use at baseline. Ef-
cacy was assessed by changes in gingival inammation, plaque, calculus, and stain, while changes in clini-
cal attachment levels and recession measurements provided safety data. A prophylaxis was provided after base-
line assessment. The 6-month plaque index (PI) was recorded immediately post-brushing after covert timing
of the subjects, and correlation analyses were run to assess the relationship of brushing time to PI. Paired t
tests, analysis of variance (ANOVA), and analysis of covariance (ANCOVA) were used to assess within and
between treatment group differences for PB (n = 76) versus M groups (n = 81).
Results: Measures of inammation showed a statistically signicant drop for both brushes at 3 and 6 months.
Mean overnight full-mouth PI scores were signicantly lower at 3 months for the PB (1.57) compared to the
M group (1.80), P = 0.0013. Immediate post-brushing PI at 6 months was also signicantly lower for the PB
(1.10) versus M (1.39) (P = 0.0025). There was an overall negative correlation for PI and brushing time (r =
0.377, P = 0.0001). Mean calculus index (CI) scores were lower for the PB at 3 (P = 0.0304) and 6 months
(P = 0.0078), while no signicant differences in stain were observable. Clinical attachment level and reces-
sion measurements showed no signicant between-group changes from baseline for either brush on canine
teeth or on teeth with recession at baseline.
Conclusion: The oscillating-rotating toothbrush safely provides clinical benefits in plaque and calculus
reduction over a manual brush even in subjects with no formal oral hygiene instruction. J Periodontol 2002;
73:770-778.
KEY WORDS
Clinical trials; dental calculus/prevention and control; gingival recession/prevention and control;
gingivitis/prevention and control; dental plaque/prevention and control; toothbrushing; dental devices,
home care.
* Marquette School of Dentistry, Milwaukee, WI.
Braun/Oral B, Boston, MA.
Marquette School of Dentistry; deceased.
StatKing Consulting, Cincinnati, OH.
Currently, Braun/Oral B, Boston, MA; previously, Braun/Oral B, Kronberg, Germany.
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771
T
he 1996 AAP World Workshop consensus report
on prevention suggested limited evidence exists
that powered toothbrushing may provide an addi-
tional benet over manual toothbrushing.
1
Reviews by
Saxer and Yankell
2,3
provide additional support for this
view. It is generally accepted that professional oral
hygiene instruction is necessary to get the maximum
benet from any device used for mechanical plaque
control. In addition, questions have been raised regard-
ing the potentially deletrious effects of improper tooth-
brush use on gingival margin position.
4,5
Several studies document that it is difcult to deter-
mine a signicant difference between powered or man-
ual toothbrush efcacy in short-term studies (2 months
or less) if no professional instruction is given.
6,7
In
contrast, when oral hygiene instruction is provided,
the newer powered brushes tend to show signicantly
better plaque removal or inflammation reduction in
studies up to 12 months.
8-11
In reality, most tooth-
brushes are purchased outside dental ofces with no
professional instruction or demonstration available to
the consumer. For powered brushes in particular, the
extent of instruction is often limited to the manufac-
turers written directions. Moreover, several studies sug-
gest that inappropriate use of a toothbrush may lead
to gingival recession.
4,12,13
The specic aims of this
study were 2-fold. First, to determine if a powered
toothbrush (PB) could be used safely in an adult pop-
ulation with no previous experience using a powered
brush and no instruction other than that available in
the packaging. Second, to compare the efcacy of the
PB and manual (M) brush in reducing gingival inam-
mation and plaque, and inhibiting calculus and stain
formation.
MATERIALS AND METHODS
Study Population
Medically healthy subjects between 18 and 65 years
of age were recruited primarily by newspaper adver-
tisement. Entry criteria included mild to moderate gin-
givitis, a minimum of 20 natural teeth, and no previ-
ous experience using a powered toothbrush. Individuals
who were pregnant or lactating were excluded. One
hundred and seventy-two subjects met the screening
criteria and signed the informed consent approved by
the Marquette University Human Subjects Institutional
Review Board. One hundred and fty-seven of these
subjects nished the trial and the data presented are
for only these subjects. The demographics of this pop-
ulation are listed in Table 1. The 15 subjects who did
not nish the trial either could not be contacted, had
moved, or were unwilling to complete the study.
Study Design (Figure 1)
The study protocol was approved by the Marquette
University Institutional Review Board and patients were
subsequently screened by a periodontist to confirm
the presence of gingivitis as determined by modied
gingival index (MGI)
14
of at least 1.2 and/or 20% or
more sites showing bleeding on probing. Based on the
screening visit, patients were stratied by gender, MGI,
plaque index (PI), and smoking using a computer pro-
gram,
using
an equation derived from the calibration data. The 4
sites were averaged to give a GCF value per patient.
This index was carried out prior to the MGI.
Two calibrated examiners then assessed full mouth
gingival inflammation using the modified gingival
index.
14
Facial/lingual marginal tissue and interprox-
imal papillae were scored on a scale of 0 to 3 as
described and full-mouth mean values were calculated.
The interexaminer standard deviation for repeated mea-
sures was 0.12 MGI units. The third and nal inam-
mation assessment was carried out after all plaque
assessments, and this consisted of dual examiners
recording the percentage of sites which bled upon gen-
tle manual probing (BOP) with a UNC-15 periodontal
probe. Efforts were made to have the same examiner
stay with the same patient throughout the study. Using
a dichotomous index (bleeding present/absent), 6 sites
per tooth were assessed 30 seconds after probing.
772
Crest, Procter & Gamble, Cincinnati, OH.
Periopaper gingival uid collection strips, ProFlow, Inc., Amityville, NY.
Periotron 8000, Pro Flow, Inc.
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J Periodontol July 2002 Dentino, Derderian, Wolf, et al.
The Turesky modication of the plaque index
19
was
recorded after the MGI assessment, and subjects were
disclosed using 4 drops of a disclosing solution, swish-
ing for 30 seconds, and rinsing twice with water. Two
calibrated examiners made all the measurements and
the interexaminer standard deviation for repeated mea-
sures was 0.14 PI units. Teeth with crowns or large
restorations were not included in the assessments.
Overnight plaque (7 to 12 hours) was assessed at both
the baseline and 3-month visits. At the 6-month visit,
subjects again reported to the clinic with overnight
plaque. However, before plaque disclosure and assess-
ment the subjects were asked to use their assigned
brush with toothpaste until they felt their teeth were
clean as they normally would do at home. This was
done out of sight of the examiners in a room equipped
with a sink, mirror, and a clock with a second hand
directly above the mirror. The subjects were timed
without their knowledge to get some idea of compli-
ance. The Turesky plaque index was carried out imme-
diately post-brushing. No personalized oral hygiene
instruction was given at any point in the study.
Statistical Analysis, Sample Size, and Power
An ANOVA was used to compare baseline means for
the 2 treatment groups for PI, CI, and stain color and
intensity, as well as to compare calculus formation at
3 and 6 months. Immediate post-brushing 2-month
plaque index was analyzed by ANCOVA using brush-
ing time as a covariate. Correlations of plaque index
with brushing time from the 6-month visit were carried
out over the entire population and by treatment (pow-
ered or manual brush). t tests were used to assess sta-
tistical signicance of the mean values for all indices
over time within both treatment groups. All measures
of inflammation (GCF, MGI, and %BOP), as well as
staining, plaque, and probing assessments (PD, REC,
and CAL) were analyzed by ANOVA as the change
from baseline to account for small differences in the
initial treatment group means. Changes in gingival
margin position were also analyzed in a subset of
patients who showed recession on non-canine teeth at
baseline (PB = 30, M = 28). The average millimeter
amount of recession on the non-canine teeth was com-
pared over 6 months for both groups.
The study was sized to have an 80% chance of detect-
ing a of 0.19 plaque index units between the power
and manual brush 3-month change from baseline PI
means if, in fact, that difference exists. The sample size
calculations used = 0.05 for a 2-sided test of hypothe-
ses. The standard deviation used in the sample size
calculations, = 0.40 plaque index units, was taken
from historical studies using the same PI. The power
analysis shows the smallest difference that would be
detectable 80% of the time if a difference exists between
treatment means for each response variable (Table 2).
RESULTS
One hundred fty-seven subjects completed the trial
(76 in the powered brush group and 81 in the manual
group). Based on the observation that all brushes/
brush heads returned at the 3- and 6-month visits
showed some amount of bristle splaying, it appeared
that all subjects had used the assigned brush.
The baseline means for PI, CI, and stain color and
intensity were not signicantly different between groups
at baseline (Table 3). The values recorded indicate
that the population as a whole had moderate overnight
plaque levels, mild calculus accumulation, and very lit-
tle stain. Probing assessments indicated that of the
157 subjects, 58 (37%) presented at baseline with at
least one vestibular site of visible recession as deter-
mined by exposure of the CEJ. In the PB group there
were 130 non-canine sites in 30 subjects with reces-
sion at baseline, while the M group had 134 non-canine
sites in 28 subjects (Table 4).
Safety Assessment
No subjects reported difculty in using their assigned
brush and there were no significant adverse effects
related to toothbrush use by patient report or by oral
exam. Canines were chosen for repeated PD and REC
measures and all buccal/facial surfaces with recession
were also assessed since these areas may be at risk
for recession.
20,21
The mean values for PD, REC, and
CAL at baseline and 6 months are shown in Table 4.
The ANOVA showed no statistically signicant differ-
773
Table 2.
Power Analysis Showing the Smallest
Difference Detectable 80% of the Time if
a Difference Exists Between Treatment
Means for Each Variable
Standard Detectable
Variable Deviation Difference Power
Plaque index CFB* 0.41 0.190 >0.80
Stain intensity 0.22 0.105 >0.80
Stain color 0.36 0.165 >0.80
Calculus index 0.99 0.455 >0.80
Gingival index CFB 0.32 0.150 >0.80
Molar GCF CFB 0.40 0.185 >0.80
BOP CFB 9.49 4.50 >0.80
Probing depth CFB 0.38 0.175 >0.80
Recession CFB 0.15 0.070 >0.80
*Change from baseline.
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Powered Versus Manual Toothbrushing Volume 73 Number 7
774
ence in these measurements over time between treat-
ment groups.
Data from individuals who showed non-canine teeth
with recession at baseline were further examined. The
amount of recession (mm) per site was averaged for
each patient and the change over time was compared.
In this evaluation, both groups showed a slight decrease
in recession from baseline to 6 months within groups,
but the changes from baseline means were not signif-
icantly different between groups (Table 4).
Measures of Inammation
All baseline measures of inflammation were similar
between the powered and manual groups (Table 3),
and they suggest that the population as a whole did
enter the trial with gingivitis. As expected, the 3 dif-
ferent measures of inflammation went down signifi-
cantly after the baseline prophylaxis as recorded at the
3-month visit and this carried over to the 6-month visit
even in the absence of ossing (Table 3 and Fig. 2A,
B, and C). All 3 independent measures followed the
same pattern for both brushes, and although the change
from baseline in full mouth % BOP and posterior inter-
proximal GCF from the PB group remained greater at
the 6-month assessment compared to the manual
group, the differences were not statistically signicant
between treatments.
Plaque, Calculus, and Stain
The efcacy of mechanical plaque removal was mea-
sured as change in overnight plaque (PI) frombaseline
to 3 months, or as immediate post-brushing of overnight
plaque (6 months). Initially, we were interested in
recording the amount of reduction seen in overnight
plaque after subjects had 3 months to get used to using
their assigned brush. At 3 months the mean whole-
mouth overnight plaque scores showed a decrease for
both brushes when compared to baseline. However,
there was a greater reduction in the full-mouth plaque
levels of the powered brush users (0.29) when com-
pared to the manual brushers (0.13), and this difference
was statistically signicant between the brushes as mea-
sured by ANOVA (P = 0.027) (Fig. 3A). Table 5 shows
the breakdown of overnight plaque in anterior, poste-
rior, and lingual sites and indicates that the powered
brush was more effective in reducing all 3 areas in com-
parison to the manual brush. Statisti-
cally signicant differences were seen
in the anterior and lingual areas, but not
in the posterior.
Subjects returned at the 6-month
assessment with overnight plaque accu-
mulation (7 to 12 hours). After calculus,
stain, GCF, and MGI assessments, the
subjects brushed their teeth, using their
assigned brush, away from the exam-
iners. Plaque was then disclosed and
the Turesky MPI recorded immediately
after brushing. The brushing time was
assessed without the subjects knowl-
Table 3.
Summary of the Mean Values (SD) for
Plaque, Calculus, and Stain Efcacy
Measures
Powered Manual
(N = 76) (N = 81) P Value
Plaque index
Baseline 1.86 (0.50) 1.93 (0.47) NS
3 months 1.57 (0.46) 1.80 (0.40) 0.0013
6 months 1.10 (0.35) 1.39 (0.36) 0.0025
Stain intensity
Baseline 0.259 (0.34) 0.266 (0.33) NS
3 months 0.09 (0.19) 0.12 (0.22) NS
6 months 0.109 (0.21) 0.174 (0.23) NS
Stain color
Baseline 0.358 (0.44) 0.358 (0.42) NS
3 months 0.145 (0.27) 0.186 (0.32) NS
6 months 0.176 (0.34) 0.286 (0.37) NS
Calculus index
Baseline 1.64 (1.25) 1.47 (1.34) NS
3 months 0.549 (0.83) 0.852 (0.90) 0.0304
6 months 0.906 (0.92) 1.33 (1.05) 0.0078
Gingival index
Baseline 1.36 (0.37) 1.38 (0.37) NS
3 months 0.49 (0.25) 0.59 (0.26) NS
6 months 0.52 (0.22) 0.58 (0.23) NS
Molar GCF (l)
Baseline 0.68 (0.33) 0.54 (0.30) NS
3 months 0.47 (0.47) 0.39 (0.24) NS
6 months 0.47 (0.35) 0.44 (0.23) NS
% BOP
Baseline 24.2 (11.5) 25.1 (12.4) NS
3 months 15.8 (11.6) 16.8 (9.2) NS
6 months 13.4 (9.2) 15.5 (9.5) NS
Table 4.
Summary of the Mean (SD) Probing Measurements
Between-
Powered Manual Group
Baseline 6 Months Baseline 6 Months P Value
Canine (N = 76) (N = 81)
PD 1.65 (0.44) 1.75 (0.34) 1.66 (0.45) 1.68 (0.40) NS
REC 0.17 (0.40) 0.14 (0.37) 0.15 (0.45) 0.15 (0.38) NS
CAL 1.24 (0.72) 1.33 (0.63) 1.20 (0.71) 1.22 (0.68) NS
Non-canine N = 30 N = 28
REC 1.45 (0.51) 1.20 (0.58) 1.63 (0.61) 1.46 (0.50) NS
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J Periodontol July 2002 Dentino, Derderian, Wolf, et al.
775
edge, and the data were used to run a correlation
analysis on whole mouth mean plaque index and
brushing time.
Immediate post-brushing plaque levels were clearly
lower for the powered brush (PB = 1.09, M = 1.39)
(Fig. 3B; Table 3), and the time spent brushing was
also signicantly longer (PB = 125 sec, M = 84 sec; P
= 0.0157). An ANCOVA was carried out to compare
the 6-month plaque levels using brushing time as the
covariate. When brushing time is accounted for, the
difference in plaque levels was still signicantly lower
for the PB (P = 0.0025).
Both brushes showed a weak negative correlation
with brushing time (PB = 0.0524, M = 0.2868), which
became stronger when the data were pooled (r =
0.37696) (Fig. 4). A single subject from the PB group
was dropped for the correlation analysis since he was
clearly an outlier in terms of brushing time (270 sec-
onds). Taking all other subjects together the negative
correlation (0.377) indicates that as brushing time
increased, plaque levels were reduced (Fig. 4). The
range of brushing times was large, from 28 to 270
seconds. However, 50 out of 76 powered brush users
spent at least 2 minutes. In contrast, only 14 out of 81
manual brushers spent 2 minutes or more brushing.
Stain and calculus recorded at baseline indicated
similar values between the 2 treatment groups at base-
Figure 2.
Change in gingival inammation. A. Whole-mouth mean MGI. B. Whole-
mouth mean % bleeding on probing (PB, n = 76; M, n = 81 for MGI
and BOP). C. Posterior interproximal gingival crevicular uid ow (PB,
n = 57; M, n = 69). P values reect within group changes from
baseline to 3 and 6 months. *PB, P = 0.009; M, P = 0.0003 (0-3
months.