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38The Journal of Clinical DentistryVol. XXIV, No. 2devices. This study compared the plaque removal efficacy of awater flosser to string floss when paired with a manual toothbrushafter a single use.Materials and MethodsSubjectsSeventy-one (71) adult male and female subjects wererecruited for the study (Table I). Subjects were enrolled if theymet the following criteria:1. Able to understand, read, and write in English and providewritten informed consent prior to participation;2. Not enrolled in another clinical study during the day ofexamination;3. Non-smoker in good general health and not pregnant at thetime of the study;4. Reported not using antibiotics within six months of thestudy, require premedication for dental treatment, or have asystemic disease that influences the oral tissue (e.g.,diabetes, autoimmune disease, medication);5. Have a minimum of 20 scoreable teeth (not including 3 rdmolars), no probing depths greater than 5 mm, and aminimum pre-brushing plaque score of 0.6;6. No hard or soft tissue lesions; and7. Good dental health with no visible carious lesions, obviousadvanced periodontal disease, orthodontic appliances, orremovable partial dentures.Figure 1A. Water Flosser (Water Pik, Inc.). The Ultra unit used in the studyincludes five tip designs and pressure setting from low to high (1 – 10).Table IDemographic DataWF Waxed Floss Overall(N = 34) (N = 36) (N = 70)Age (years)Mean 45.2 44.6 44.9SD 10.45 10.27 10.29SEM 1.79 171 1.23Range 25 – 63 25 – 64 25 – 64GenderMale 6 (17.6%) 10 (27.8%) 16 (22.9%)Female 28 (82.4%) 26 (72.2%) 54 (77.1%)SD = Standard Deviation, SEM = Standard Error of the Meanp-value for age (p = 0.962) from a Wilcoxon rank-sum testp-value for gender (p = 0.398) from a Fisher’s Exact testThe study forms and protocol were approved by theinstitutional review board (Institutional BRCL). Subjectscompleted a medical history and read and signed a consent formprior to inclusion in the study.Study DevicesThe Waterpik ® Ultra Water Flosser (WF group, Model WP-100, Water Pik, Inc., Fort Collins, CO, USA) is a pulsating oralirrigator with a reservoir, pressure control, and handle for tipplacement (Figure 1A). The tip is directed at the gingival marginand approximal areas of all teeth, following a pattern around themouth cleaning the facial and lingual surfaces. The Classic JetFigure 1B. Classic Jet Tip. Tip is held close at a 90-degree angle to the tooth atthe gingival margin and follows a pattern around the mouth to clean all facialand lingual areas of the teeth.Tip was used for this study (Figure 1B), delivering 500 ml ofwarm water using medium-high pressure.Unflavored waxed dental floss (SF group; Johnson &Johnson, Morris Plains, NJ, USA) was precut to 18” andprovided to the subjects. Subjects cleaned the proximal surfacesof all teeth following instructions for wrapping the floss aroundeach tooth on the mesial and distal surfaces forming a “C,” andmoving up and down the surfaces several times.Study DesignThis independent, single-blind, single-use, parallel clinicaltrial compared the plaque removal efficacy of a manualtoothbrush paired with either a WF or SF. Subjects wererandomized into one of two groups prior to pre-cleaning plaquescore recording. Group 1 received the WF and group 2 receivedthe waxed string floss (SF). All subjects used a new AmericanDental Association standard manual toothbrush (Oral-B ®Indicator 35, Procter & Gamble, Cincinnati, OH, USA) and
Vol. XXIV, No. 2 The Journal of Clinical Dentistry 39Crest ® Cavity Protection Toothpaste, regular mint favor (Procter& Gamble, Cincinnati, OH, USA). The study endpoint was thesingle-use change scores of the Rustogi Modification of theNavy Plaque Index (RMNPI) for whole mouth, marginal,approximal, facial, and lingual areas. 12Subjects abstained from brushing and all other oral hygienemethods for 23–25 hours prior to their appointment. Oral softand hard tissues were assessed at the pre- and post-cleaningevaluations. Subjects rinsed with an erythrosine (FD&C #3)disclosing solution (Gemiphene Corporation, Brantford, ON,Canada) for one minute and then expectorated. Data werecollected by one experienced examiner proficient using theRMNPI, and who was blinded to the treatment assignments.There are nine sections to score with the RMNPI. Sections arecombined to provide data for the marginal and approximalregions (Figure 2).Figure 2. Rustogi Modification of the Navy Plaque Index. Plaque is assessed foreach tooth area (A through I) and is scored using the following scale: 0 =absent, and 1 = present. Facial and lingual surfaces of all gradable teeth arescored and a mean plaque index (MPI) is calculated for each subject at eachexamination. Subjects’ scores were calculated for the whole mouth (areas Athrough I), along the gingival margin (areas A through C), and proximal(approximal; areas D and F).Verbal instructions were given to each subject followed by ademonstration on a mouth model: Bass technique for thetoothbrush; manufacturer’s instructions for the water flosser;and standard flossing instructions for the waxed floss. Eachsubject brushed for a timed two-minutes and was supervised tomake sure they were using the proper technique throughout thebrushing process. They rinsed and immediately commencedwith interdental cleaning using either the WF or SF. The WFgroup filled the reservoir with 500 ml of warm water andplaced the pressure setting on medium-high. The subjects weredone when they had cleaned each interproximal area andproximal surface with the floss or when the WF reservoir wasempty.Statistical AnalysisData were collected for each subject and recorded on CaseReport Forms (CRFs) in black ballpoint pen. The CRFs werecompleted and reviewed for accuracy of all data, and thensigned by the principle investigator. The CRFs underwent keybatch entry and verification. Data were tabulated according tothe clinical scoring appropriate for the RMNPI.With 35 subjects per group, the study would have over 90%power to detect a clinically significant difference when theaverage plaque reduction for the Waterpik Water Flosser plusmanual toothbrush is 75% when compared to the averagereduction of 50% for waxed string floss plus manual toothbrushfor whole mouth plaque.The primary outcome was to determine the removal andreduction of plaque from tooth surfaces from pre-treatmentbaseline and between groups measured by the reduction in theRMNPI after a single use.The primary comparison evaluated the mean change betweenthe groups, utilizing a between independent groups one-wayanalysis of variance (ANOVA). Within groups pre-postcomparisons were also evaluated using the pre-post changescore. Data were summarized using descriptive statistics (mean,median, minimum, maximum, and standard deviation) bytreatment group and overall. No statistical adjustments weremade for multiple comparisons or multiple tests. All statisticaltests were conducted using a significance level of α = 0.05.ResultsSeventy subjects (70) completed the study. There were 34subjects in the WF group and 36 subjects in SF group. Onesubject dropped out from the WF group due to personal reasons.There were no differences in demographics or baselinecharacteristics between the groups at baseline. The twotreatments did not differ at pre-treatment for whole mouth andfacial plaque scores and were the same for approximal andmarginal regions, indicating no differences at baseline betweenthe groups. The pre-treatment lingual scores were 0.64 for WFand 0.62 for SF which did differ statistically (p = 0.04), but wasnot considered clinically relevant (Table II).Whole MouthThe WF and SF groups showed statistically significantchanges from pre-cleaning to post-cleaning score for wholemouth RMNPI; 74.4% and 57.7%, respectively (p < 0.001). TheWF group was 29% more effective than the SF group for wholemouth plaque removal (p < 0.001; Table II, Figure 3).Marginal RegionBoth groups showed significant reduction between pre- andpost-cleaning scores; 68.2% for WF group and 51.1% for SFgroup (p < 0.001). The difference between the groups was 33%(p < 0.001), demonstrating a significant difference in favor ofthe WF group (Table II, Figure 3).Approximal RegionThe WF and SF groups showed statistically significant
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