Evaluation of the Plaque Removal Efficacy of a Water Flosser

Compared to String Floss in Adults After a Single Use

C. Ram Goyal, BDS
BioSci Research Canada Ltd.
Mississauga, Ontario, Canada
Deborah M. Lyle, RDH, BS, MS
Water Pik, Inc.
Fort Collins, CO, USA
Jimmy G. Qaqish, BSc
BioSci Research Canada Ltd.
Mississauga, Ontario, Canada
Reinhard Schuller, MSc
Reinhard Schuller Consulting
Toronto, Ontario, Canada

Abstract
• Objective: To compare the plaque removal efficacy of a water flosser to string floss combined with a manual toothbrush after a
single use.
• Methods: Seventy adult subjects participated in this randomized, single-use, single-blind, parallel clinical study. Subjects were
assigned to one of two groups; Waterpik® Water Flosser plus a manual toothbrush (WF) or waxed string floss plus a manual
toothbrush (SF). Each participant brushed for two minutes using the Bass technique. The WF group added 500 ml of warm water to
the reservoir and followed the manufacturer’s instructions, and the SF group used waxed string floss between each tooth, cleaning the
mesial and distal surfaces as instructed. Subjects were observed to ensure they covered all areas and followed instructions. Scores
were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject using the Rustogi Modification of
the Navy Plaque Index.
• Results: The WF group had a 74.4% reduction in whole mouth plaque and 81.6% for approximal plaque compared to 57.7% and
63.4% for the SF group, respectively (p < 0.001). The differences between the groups showed the water flosser was 29% more
effective than string floss for overall plaque removal and approximal surfaces specifically (p < 0.001). The WF group was more
effective in removing plaque from the marginal, lingual, and facial regions; 33%, 39%, and 24%, respectively (p < 0.001).
• Conclusion: The Waterpik Water Flosser and manual toothbrush is significantly more effective than a manual brush and string floss
in removing plaque from tooth surfaces.
(J Clin Dent 2013;24:37–42)

Introduction demonstrating that the recommendation of floss is based more on

Plaque is a risk factor for periodontal disease and needs to be tradition than science. Hujoel and colleagues6 reported that daily
controlled or eliminated on a daily basis. Most people in the flossing did not reduce the incidence of proximal caries.
industrialized world brush their teeth at least once a day.1,2 Surprisingly, the review reported a lack of studies on adults, and
However, the outcome is less than desirable as evidenced by the studies with adolescents utilized professional flossing on
epidemiological studies that show a significant prevalence in school children. A systematic review by Berchier and colleagues7
gingivitis and more advanced periodontal disease.3 Even the best compared brushing alone to brushing and flossing, and found no
brushers can only clean 60% of the tooth surface, leaving benefit in the reduction of inflammation or plaque. Likewise, Slot,
significant plaque in the interproximal area which is difficult to et al.8 evaluated the efficacy of interdental brushes compared to
access with a toothbrush alone.4 brushing alone or brushing paired with string floss or wood stick.
Perhaps of greater importance is the need to remove plaque on The review reported that five of eight studies showed a positive
the proximal surfaces of teeth. Periodontal infections generally significant difference for plaque index in favor of the interdental
start and are more pronounced in this area because it is an ideal brushes when compared to floss, and one of two when compared
place for biofilm to proliferate and it is difficult to remove.5 String to wood sticks. There were no differences found for gingival
floss has long been the standard of care for cleaning the proximal bleeding or inflammation compared to either floss or wood sticks.
surface of the tooth. First introduced in the late 1800s, floss People do not like to floss, do not feel proficient with floss, and
continues to be the recommendation of choice by most dental if given a choice will choose another interdental device.9-11 There is
professionals. Recently, there have been systematic reviews a need for clinical studies that address the efficacy of interdental

37
38 The Journal of Clinical Dentistry Vol. XXIV, No. 2

devices. This study compared the plaque removal efficacy of a

water flosser to string floss when paired with a manual toothbrush
after a single use.

Materials and Methods

Subjects
Seventy-one (71) adult male and female subjects were
recruited for the study (Table I). Subjects were enrolled if they
met the following criteria:

1. Able to understand, read, and write in English and provide

written informed consent prior to participation;
2. Not enrolled in another clinical study during the day of
examination;
3. Non-smoker in good general health and not pregnant at the
time of the study;
4. Reported not using antibiotics within six months of the
study, require premedication for dental treatment, or have a
systemic disease that influences the oral tissue (e.g.,
Figure 1A. Water Flosser (Water Pik, Inc.). The Ultra unit used in the study
diabetes, autoimmune disease, medication); includes five tip designs and pressure setting from low to high (1 – 10).
5. Have a minimum of 20 scoreable teeth (not including 3rd
molars), no probing depths greater than 5 mm, and a
minimum pre-brushing plaque score of 0.6;
6. No hard or soft tissue lesions; and
7. Good dental health with no visible carious lesions, obvious
advanced periodontal disease, orthodontic appliances, or
removable partial dentures.

Table I
Demographic Data
WF Waxed Floss Overall
(N = 34) (N = 36) (N = 70)
Age (years)
Mean 45.2 44.6 44.9
SD 10.45 10.27 10.29 Figure 1B. Classic Jet Tip. Tip is held close at a 90-degree angle to the tooth at
SEM 1.79 171 1.23 the gingival margin and follows a pattern around the mouth to clean all facial
Range 25 – 63 25 – 64 25 – 64 and lingual areas of the teeth.

Gender
Male 6 (17.6%) 10 (27.8%) 16 (22.9%) Tip was used for this study (Figure 1B), delivering 500 ml of
Female 28 (82.4%) 26 (72.2%) 54 (77.1%) warm water using medium-high pressure.
SD = Standard Deviation, SEM = Standard Error of the Mean
p-value for age (p = 0.962) from a Wilcoxon rank-sum test Unflavored waxed dental floss (SF group; Johnson &
p-value for gender (p = 0.398) from a Fisher’s Exact test Johnson, Morris Plains, NJ, USA) was precut to 18” and
provided to the subjects. Subjects cleaned the proximal surfaces
of all teeth following instructions for wrapping the floss around
The study forms and protocol were approved by the each tooth on the mesial and distal surfaces forming a “C,” and
institutional review board (Institutional BRCL). Subjects moving up and down the surfaces several times.
completed a medical history and read and signed a consent form
prior to inclusion in the study. Study Design
This independent, single-blind, single-use, parallel clinical
Study Devices trial compared the plaque removal efficacy of a manual
The Waterpik® Ultra Water Flosser (WF group, Model WP- toothbrush paired with either a WF or SF. Subjects were
100, Water Pik, Inc., Fort Collins, CO, USA) is a pulsating oral randomized into one of two groups prior to pre-cleaning plaque
irrigator with a reservoir, pressure control, and handle for tip score recording. Group 1 received the WF and group 2 received
placement (Figure 1A). The tip is directed at the gingival margin the waxed string floss (SF). All subjects used a new American
and approximal areas of all teeth, following a pattern around the Dental Association standard manual toothbrush (Oral-B®
mouth cleaning the facial and lingual surfaces. The Classic Jet Indicator 35, Procter & Gamble, Cincinnati, OH, USA) and
Vol. XXIV, No. 2 The Journal of Clinical Dentistry 39

Crest® Cavity Protection Toothpaste, regular mint favor (Procter Statistical Analysis
& Gamble, Cincinnati, OH, USA). The study endpoint was the Data were collected for each subject and recorded on Case
single-use change scores of the Rustogi Modification of the Report Forms (CRFs) in black ballpoint pen. The CRFs were
Navy Plaque Index (RMNPI) for whole mouth, marginal, completed and reviewed for accuracy of all data, and then
approximal, facial, and lingual areas.12 signed by the principle investigator. The CRFs underwent key
Subjects abstained from brushing and all other oral hygiene batch entry and verification. Data were tabulated according to
methods for 23–25 hours prior to their appointment. Oral soft the clinical scoring appropriate for the RMNPI.
and hard tissues were assessed at the pre- and post-cleaning With 35 subjects per group, the study would have over 90%
evaluations. Subjects rinsed with an erythrosine (FD&C #3) power to detect a clinically significant difference when the
disclosing solution (Gemiphene Corporation, Brantford, ON, average plaque reduction for the Waterpik Water Flosser plus
Canada) for one minute and then expectorated. Data were manual toothbrush is 75% when compared to the average
collected by one experienced examiner proficient using the reduction of 50% for waxed string floss plus manual toothbrush
RMNPI, and who was blinded to the treatment assignments. for whole mouth plaque.
There are nine sections to score with the RMNPI. Sections are The primary outcome was to determine the removal and
combined to provide data for the marginal and approximal reduction of plaque from tooth surfaces from pre-treatment
regions (Figure 2). baseline and between groups measured by the reduction in the
RMNPI after a single use.
The primary comparison evaluated the mean change between
the groups, utilizing a between independent groups one-way
analysis of variance (ANOVA). Within groups pre-post
comparisons were also evaluated using the pre-post change
score. Data were summarized using descriptive statistics (mean,
median, minimum, maximum, and standard deviation) by
treatment group and overall. No statistical adjustments were
made for multiple comparisons or multiple tests. All statistical
tests were conducted using a significance level of α = 0.05.

Results
Seventy subjects (70) completed the study. There were 34
subjects in the WF group and 36 subjects in SF group. One
subject dropped out from the WF group due to personal reasons.
There were no differences in demographics or baseline
characteristics between the groups at baseline. The two
treatments did not differ at pre-treatment for whole mouth and
facial plaque scores and were the same for approximal and
marginal regions, indicating no differences at baseline between
Figure 2. Rustogi Modification of the Navy Plaque Index. Plaque is assessed for
the groups. The pre-treatment lingual scores were 0.64 for WF
each tooth area (A through I) and is scored using the following scale: 0 = and 0.62 for SF which did differ statistically (p = 0.04), but was
absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are not considered clinically relevant (Table II).
scored and a mean plaque index (MPI) is calculated for each subject at each
examination. Subjects’ scores were calculated for the whole mouth (areas A
through I), along the gingival margin (areas A through C), and proximal
Whole Mouth
(approximal; areas D and F). The WF and SF groups showed statistically significant
changes from pre-cleaning to post-cleaning score for whole
Verbal instructions were given to each subject followed by a mouth RMNPI; 74.4% and 57.7%, respectively (p < 0.001). The
demonstration on a mouth model: Bass technique for the WF group was 29% more effective than the SF group for whole
toothbrush; manufacturer’s instructions for the water flosser; mouth plaque removal (p < 0.001; Table II, Figure 3).
and standard flossing instructions for the waxed floss. Each
subject brushed for a timed two-minutes and was supervised to Marginal Region
make sure they were using the proper technique throughout the Both groups showed significant reduction between pre- and
brushing process. They rinsed and immediately commenced post-cleaning scores; 68.2% for WF group and 51.1% for SF
with interdental cleaning using either the WF or SF. The WF group (p < 0.001). The difference between the groups was 33%
group filled the reservoir with 500 ml of warm water and (p < 0.001), demonstrating a significant difference in favor of
placed the pressure setting on medium-high. The subjects were the WF group (Table II, Figure 3).
done when they had cleaned each interproximal area and
proximal surface with the floss or when the WF reservoir was Approximal Region
empty. The WF and SF groups showed statistically significant
40 The Journal of Clinical Dentistry Vol. XXIV, No. 2

Table II
Pre-cleaning RMNPI and Post-cleaning Plaque Removal
Pre-Cleaning Post-Cleaning Change Score % Change*
Mean (SD) Mean (SD) Mean (SD)
Whole Mouth WF 0.65 (0.047) 0.17 (0.050) 0.48 (0.043) 74.4%
SF 0.64 (0.039) 0.27 (0.069) 0.37 (0.053) 57.7%
Marginal WF 1.00 (0.000) 0.32 (0.083) 0.68 (0.083) 68.2%
SF 1.00 (0.000) 0.49 (0.114) 0.51 (0.114) 51.1%
Approximal WF 1.00 (0.000) 0.18 (0.079) 0.82 (0.079) 81.6%
SF 1.00 (0.000) 0.37 (0.101) 0.63 (0.101) 63.4%
Facial WF 0.65 (0.069) 0.09 (0.062) 0.56 (0.070) 85.7%
SF 0.66 (0.074) 0.20 (0.086) 0.46 (0.070) 69.4%
Lingual WF 0.64 (0.041) 0.24 (0.078) 0.40 (0.060) 62.9%
SF 0.62 (0.032) 0.34 (0.095) 0.28 (0.076) 45.2%
SD = Standard Deviation
*Change from pre-cleaning p < 0.001

*Significant difference in favor of the WF compared to SF (p < 0.001) for all assessments

Figure 3. Mean % reduction in Plaque (RMNPI)

changes from pre- and post-cleaning scores for the approximal WF group was more effective for plaque removal on the
region; 81.6% and 63.4%, respectively. The WF group showed lingual surface, 62.9% compared to 45.2% (p < 0.001). The
superior plaque removal compared to the SF group (29%, p < WF was 24% more effective on the facial and 39% on the
0.001; Table II, Figure 3). lingual surfaces compared to the string floss group (Table II,
Figure 3).
Facial and Lingual
Both groups demonstrated significant differences from pre- Discussion
cleaning scores to post-cleaning scores for the facial and Tooth brushing is the most common and practical way to
lingual surfaces (p < 0.001). The WF group was significantly remove supragingival plaque from the tooth surface to help
more effective than the SF group for plaque removal on the prevent gingival inflammation. People tend to form brushing
facial surfaces, 85.7% versus 69.4% (p < 0.001). Likewise, the habits that are repeated, leading to consistent areas that are not
Vol. XXIV, No. 2 The Journal of Clinical Dentistry 41

cleaned regardless of how many times they brush or for how oral health with a water flosser were not related only to
long.13 Brushing time and technique are variables that impact improvements in plaque, but related to a down regulation of pro-
outcomes, with an average brushing time of 50 seconds and inflammatory mediators.26 This study was designed to look at
techniques that do not clean the angles and margins effectively.13 plaque removal specifically.
Plaque left on tooth surfaces, especially at the marginal area, can All products were found to be safe to use and there were no
impact the initiation and proliferation of subgingival bacteria, reported adverse events from the single brushing and interdental
increasing the risk for gingivitis and periodontal infections.14,15 cleaning with either the WF or SF. Subjects did not have any
Twice-daily brushing for two minutes is based on empirical problems using either product. These results are in line with
rather than scientific evidence, since asking people to brush other studies that showed a significant reduction in plaque from
more frequently or longer can be futile. This needs to be baseline in favor of the water flosser compared to the control
coupled with interdental cleaning once daily to control biofilm group. The question of whether a water flosser can remove
formation where infection and gingivitis are likely to occur.5 The plaque has been answered in the affirmative. More importantly,
use of dental floss as the standard of care is questionable and the outcomes showing a reduction in inflammation,19-23,26 pocket
other devices should be investigated. depth,26 subgingival bacteria,27-29 and gingival bleeding19-23 in
The purpose of this study was to evaluate the efficacy of a studies of four weeks and greater can support the regular
water flosser interdental cleaning device and compare it to string recommendation of the water flosser as a key device in
floss on plaque removal after a single use. The RMNPI allowed maintaining optimal oral health.
for evaluation of different areas and surfaces of the tooth, and
provided a clearer picture of the plaque removal efficacy of each Conclusions
product. It is interesting to note that string floss has been around From an analysis of this clinical trial we observed the following:
for well over a century, but there is little data available to
support its standing as a primary interdental cleaner.7 The water 1. The Waterpik Water Flosser paired with a manual
flosser, originally known as an oral irrigator, was first introduced toothbrush is significantly more effective than string floss for
to the dental profession in 1962. Currently, there are over 50 removing plaque. Specifically, the group utilizing the WF
clinical studies on one design (Waterpik Water Flosser) that has had 29%–39% better plaque removal.
a pulsation and pressure combination and has shown significant 2. The WF is significantly more effective than string floss in
reductions in inflammation and plaque. The water flosser has reducing plaque, including in hard-to-reach areas of the
been tested on many different cohorts such as implants,16 fixed mouth often missed by brushing.
orthodontics,17 individuals living with diabetes,18 gingivitis,19-21 3. Both the WF and SF are safe to use.
and those with mild to moderate periodontal disease,22,23
demonstrating significant improvements in oral health in favor of Acknowledgment: The authors would like to thank the team at BioSci
the water flosser group compared to traditional or normal oral Research Canada, Ltd. for their valuable contribution to this study. This study
was supported by a research grant from Water Pik, Inc., Fort Collins, Colorado.
hygiene regimens, including string floss.
In this study, the WF group was more effective in removing
plaque from all areas and surfaces compared to the SF group. For correspondence with the authors of this paper, contact
The 29% better reduction in approximal scores is important, Deborah M. Lyle – dlyle@waterpik.com.
especially since the flossing group was instructed and supervised
in the proper technique of wrapping the floss around the tooth References
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