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    Ccahuana-Vasquez, 2018. (An 8-Week Clinical Comparison of An Oscillating-Rotating Electric Rechargeable Toothbrush and A Sonic Toothbrush in The Reduction of Gingivitis and Plaque) PDF

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    An 8-Week Clinical Comparison of an Oscillating-Rotating Electric Rechargeable Toothbrush and a Sonic Toothbrush in the Reduction of Gingivitis and Plaque Renzo A, Ceahuana-Vasquer, DDS, PhD Procter & Gamble Kronberg, Germany. Erinn L. Conde, BS Pamela Cunningham — Julie M. Grender, PhD Procter & Gamble Mason, OH, USA AIS Abstract + Objective: To evaluate and compare the efficacy of a marketed oscillating-rotatng electric rechargeable toothbrush fo a marketed sonic toothbrush in the reduction of gingivitis and plaque over an S-week period. + Methods: This wasa randomized, examiner-blind, parallel group, eight-week study. Subjects with presence of mild-to-moderate plaque and gingivitis received an ora examination and were evaluated for bassline gingivitis (Modified Gingival Index; MGD, gingival bleeding (Gingival Bleeding Index; GBI), and plaque (Rustogi Modified Navy Plaque Index). Qualified subjects were randomly assigned toan ceniry-level owillating rotating electric rechargeable brush handle (Oral-B® PRO 1000, DIGU) with a round brush head with angled bris- tes (Oral-B CrossAction, EBS0) or a premium sonic brush (Philips Sonicare® Diamond Clean Toothbrush with AdaptiveClean brush head), One hundred and fifty subjects were instructed to brush twice daly with their assigned brush and a fluoride dentifrice freight vwecks before returning foran oral examination and gingivitis and plaque evaluations. The same methods were used at baseline and Week 8 forall evaluations ‘Results: One hundred and forty-ight subjects completed the studs, 74in each group. After eight wecks of use, both brushes reduced ‘MGI, GBI, total numberof bleeding sites whole mouth plague, gingival margin plaque, and proximal plague (p < 0.001 foreach). The oseillating-rotating brush provided statistically significantly greater reductions than the sonic brush fora gingivitis measures, with a 34.8%, 48.4%, and 42.6% greater reduction for MGI, GBI, and numberof bleeding sites respectively, after eight weeks of use (p < 0.001 for each). Significantly seater whole mouth (26.2%) and proximal (38.5%) plaque reductions were also demonstrated at Week 8 forthe cosellating-rotating brush versus the sonic brush (p <0.001). + Conclusion: The entry-level osillating-rotafing brush performed better than the premium sonic brush in the reduction of plaque and gingivitis in tis eight-week randomized and examiner-bind study. (4.Clin Dent 2018:29:27-32) Introduction (Oral disease involving dental plaque is prevalent worldwide. ing brushes, which typically have a small round brush head, per- Globally, up to 802% of the adult population suffers from gingivitis form alternating clockwise and counterclockwise movements. and up to 11% has severe periodontitis '* The prevalence of dental ‘Various brush head and filament designs have been introduced caries is significantly greater, n some countries affecting more than jn manual and power brushes to improve both the efficacy of plaque 80% of the population, Periodontal disease and dental caries are removal and patients’ brushing experiences: One oscillating-rotat- ‘multifactorial and require the presence of periodontal pathoge ing brush head design utilizes the CrissCross® 16-degroe bristle ‘and cariogenic bacteria, respectively, in dental plaque. Effective arrangement, fist introduced in the Oral-B" CrossAction manval ‘mechanical removal of dental plaque through oral hygiene, and toothbrush to optimize plaque removal This electric brust head chemotherapeutic that reduce and inhibit dental plague, are criti= incorporates a central tuft with straight filaments, an outer ring cal elements forthe control of periodontal diseases and dental caries ‘with +16° angle bristle filaments for the oscillation’ forward direc= “Tooth brushing is the most common method of plaque removal tion, and an inner ring with -16° brsties forthe backward direc- ‘Options include numerous manual toothbrush designs as well as tion,” The angled bristles flare to enhance coverage of the tooth electric toothbrush models with oscillating-otating and sonic modes surface, The brush head has high bristle density and « high-low of action being the most popular. Sonic toothbrushes move in a trim for contour adaptation, Several systematic reviews and clini- side-to-side sweeping motion to remove plague. Oxcillating-rotat- cal studies have shown that osillating-otating toothbrushes more 7 28 ‘The Journal of Clinical Dentistry effectively remove dental plaque than manual brushes! Recently, ‘aclnial study ofa premium sonic brush and new brush head report. ed greater plaque and gingivitis reduction compared to oscillating "tating technology when the brushes were used in spealty modes” The objective of this current trial was to compare the premium sonie toothbrush to an entry-level oscllating-rotating toothbrush with the CrossAction brush head when both brushes were used under standard brushing conditions. ‘Materials and Methods This was an cight-week, single-center, randomized, two-treat= ‘ment, examiner-blind, open label, parallel group study. Institutional Review Board approval was obtained for the study protocol and. informed consent form prior to commencing the study (16168 13:52:5826-06-2017), Potential subjects provided written informed ‘consent prior to their participation, They were instructed to abstain from oral hygiene for 12 hours prior to their Baseline and Week 8 Visits and to abstain from eating chewing gum, drinking, and tobac- 0 use forfour hours prior to both appointments, At the baseline Visit, subjects received an oral examination followed by assessment. of gingivitis using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI). Next, an assessment of plaque was performed using the Rustogi Modified Navy Plaque Index (RMNPI.* Qualified subjects had to be 18 years of age or older, in good general health, and have at least 16 natural teeth with facial and lingual scoreable surfaces, excluding third molars, crowns, or bridges, and teeth with restorations covering > 50% ofthe tooth surface and/or orthodontic appliances. In order to participate in the study subjects had to meet all other inclusion criteria and were required to have mild-to-moderate gingivitis with a baseline gin- Bivits score (MGI) of at feast 1.75 but not greater than 2.3; a ‘minimum of 10 bleeding sites (GBI = | or 2), and a whole mouth RMNPI score greater than 0.50. Subjects (n = 150) were stratified based on their baseline scores for MGI (s 2.1 vs. > 2.1), number of bleeding sites (« 21.0 vs. > 21.0), whole mouth mean RMNPI («0,62 vs > 0.62), and toba- co use. Subjects were then randomly assigned to one of two treat- ‘ment groups (Figure I) + Anentry-level oxillating-rotating electric rechargeable tooth- brush handle with a brush head incorporating angled bristles (Oral-B* PRO 1000 and Oral-B* CrossAction brush head, DIGU/EBS0; Procter & Gamble, Cincinnati, OH, USA) and a standard anti-cavity fluoride dentifrice (Crest” Cavity Protection, Procter & Gamble, Cincinnati, OH, USA): or, + A premium sonic brush and brush head with elastomer- ‘anchored bristle tufts (Philips Sonicare" DiamondClean with ‘AdaptiveClean brush head, also marketed as Premium Plaque ‘Control or Premium Plague Defense, depending on the coun- ty: Philips Sonicare, Bothell, WA, USA) and the same anti- cewity Muoride dentiftoe, To ensure product assignment was examiner-blind, subjects received their assigned products and instructions on oral hygiene and produet usage in a separate area. Subjects were instructed 10 brush with their assigned brush and dentifrice for 2 minutes, twice- aily for eight woeks (+/- days), using the regular defiult cleaning ‘mode in aecordance with the manufacturer’ instructions ‘Daily Vol. XXIX, No.1 gre Tx pres: rsh wil rahe (ef) oiling lic recharge rash and wit ad br ad ih angled rs ght) Clean Mode’ and ‘Clean Mode’ for the oscillating-rotating and sonic brush, respectively. To ensure that the regular cleaning mode ‘was used, the Easy Start feature on the sonic brush was deactivat- ed prior to product assignment. Subjects brushed according to the provided usage instructions with their assigned toothbrush and ‘toothpaste in front of a mirror and under supervision. This on-site practice brushing was considered one of the subjects’ two daily bushings. At the Week 8 vist, it was first confirmed that subjects stillet the study criteria and were following all instructions includ ing refraining from using any oral hygiene products untelated to te study. Each subject then received an oral examination and gin= sivitis and plaque evaluations in the same manner as atthe base- Tine visit Glnical Assessments All clinical assessments at Bascine and Week 8 were performed by the same experienced examiner." The oral examination was ‘conducted first by visual examination ofthe oral, oropharyngeal, ‘and peti-oral sof tissues, utilizing a standard dental light, dental ‘mirror, and gauze, Dental hard tissues and restorations were exam- ined visually utilizing a standard dental light, dental mirror, and ai syringe. Any abnormal findings were noted. The sequence for assessment of gingivitis and plague was MGI, GBI, and then, RMNPL The gingivitis assessment (MGI) was conducted by scoring inflam mation of the buccal and lingual marginal gingiva and interdental papillae ofall coreable teeth (six sites per tooth) on a scale of 0 10 4 (0= normal (absence of inflammation); 1 = mild inflammation (slight change of eolo, litle change in texture) of any portion of, but not the entire, marginal or papillary gingival area; = mild inflamma tion of the entire gingival area; 3 = moderate inflammation (moder- ate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingiva area; and, 4 = severe inflammation (marked red- ness.and edema/hypertrophvy, spontaneous bleading, or ulceration) ‘of the marginal or papillary gingival are.” Whole mouth MGI scores Vol. XXIX, No.1 \were computed by summing all scores and dividing this total by the numberof scorad sites GBI evaluations were conducted as defined by Saxton and van der Ouderaa." The gingiva was first light air- dried and a periodontal probe with 0.5 mm diameter tip was then inserted into the gingival crevice to.a depth of 2 mm or until slight resistance was felt. The probe was then run around the tooth at this depth at an angle of approximately 60°, gently stretching the suleular epithelium while using minimum axial fore to avoid undue penetration into the tissue. The buceal, mesial/distal, and lingual gingival areas were probed inthis manner, waiting approximately 30 seconds before recording the number of sites with bleeding, accon- ing othe following scale: 0 = absence of bleeding afer 30 seconds; 1 bleeding observed after 30 seconds; and 2 = immediate bleed- ing observed. The whole mouth GBI score was determined by sui ‘ming the scores and dividing this by the number of scoreable sites examined. The number of bleeding sites was determined by the {otal numberof sites that had a GBI score of a 1 or 2 ‘Dental plaque was evaluated using the RMNPI, after using a disclosing agent on all surfaces (Chrom-O-Red erythrosine FD&C red 3 disclosing solution; Germiphene Corp., Bradford, Ontario, (Canada) to stain for the presence of plaque” RMNNPI scores were recorded forall natural teeth, with the exception of third molars, crowns, and surfaces with cervical restorations. This resulted in hine sites per surface, with a total of up to 504 sites. Plaque was recorded as absent (0) or present (1) on each of nine tooth areas (A-1 onal buceal and lingual surfaces (Figure 2). The whole mouth RMNPI score was calculated by summing the total number of sites with plague and dividing this by the total number of sites scored. Gingival margin RMNPI scores were calculated using the scores for areas A-C, and proximal RMNPI using the scores for sites D and F (Figure 2) Data Analysis and Statistical Methods “The sample size was determined by power analyses conducted with a = 0.0, using a 2-sded test. Assuming a variability of whole mouth MGI of 0.080. a sample size of 75 subjects per group was to provide 90% power to detect a mean treatment difference in MGI ———————————— Rustogi Modification of the Navy Plaque Index ge Sis sora ing she RMINPL ‘The Journal of Clinical Dentistry » scores of 0.043, Group differences for age were compared using & two-sample Lest, and a Chi-Square test was used to asses gender and ethnicity balanee between the two groups, while Fishers Exact test was used to assess smoking status balance. Mean treatment group changes in MGI, GBI, number of bleeding sites, and RMNPI scores were calculated separately using the results of clini= cal assessments at baseline and at Week 8. An analysis of covati= ance (ANCOVA) was performed to determine treatment differ= ences for the whole mouth mean gingivitis reduction with the respec tive baseline gingivitis score as the covariate. Similar analyses were carried out for each gingivitis endpoint (MGI, GBI, and number of bleeding sites), with MGI being primary, and for whole mouth ‘mean plaque reduction with the whole mouth RMNPI baseline score asthe covariate. A similar method was used for gingival mar- gin and proximal RMNPI scores except that an ANOVA was care ried out for these because the baseline plaque scores were 1,0 forall subjects in the gingival margin and proximal areas. All statistical tests for treatment comparisons were two-sided with a significance level of a= 0.05, Results ‘One hundred and fity subjects were randomized to treatment ‘with a total of 148 subjects completing the study (74 in each teat- ‘ment group). The mean age of all randomized subjects was 4 years, ‘Overall 68.7% of subjects were female, 55.3% were Caucasian, ‘and 92.7% were nonsmokers. No statistically significant betwoen- group differences were found for ave, gender, ethnicity, or smoking status (p= 0.250; Table I). MG, GBI, and Bleeding Site Scores The mean Baseline and Week 8 MGI, GBI, and number of bleeding sites together with their percentage changes, are shown in Table II. Enrolled subjects presented with MGI scores of 2.093 ‘Table L Demographic Characteristics of Study Participants Dengan Tne! Prono Characters O-R'(N=75)__—_sone(@=75) Aaateany Mean a7 23 40 sD Be Ba a Minn 8 8 is Maximum » " » Gener Female 116800) ROM — 103647 Male 2c) neum 70139 thn Ceasan 38607%) ssc 653%) Non-Cacsian — 37(0.3%) moan) TAT) ‘Ser Ye sa S67 103% No oon TER) —_—_ HDT) ‘OR=Oilaingsating Twa sample est wan ied 0 compare man as betwen the wo teatment groups (p= 052, ‘Namber and percent of sujet cach category “ChSquartet was ed toes gender (P= 186) and ethic (p= 0.28) bun batwee the wo groups Fishers Exact es as wed 10 6 oking stats (p= 0.754) balance betwen thetwo groups (oscillating-rotating group) and 2,096 (sonic group) at baseline, with no statistically significant differences between the groups (p= 0.824), The baseline mean GBI scores were 0.138 and 0.149, respectively, for the oscillating-rotating and sonic brush groups (P= 0.540) and 20.28 and 20.16, respectively forthe baseline mean ‘number of bleeding sites (p= 0.951). Both brushes showed a statis | tically significant reduction in gingivitis at Week 8, as assessed by | ‘MGI, GBI, and number of bleeding sites (p < 0.001; Figure 3). Mean reductions in MGI scores were 0.345 (16.5%) and 0.256 (12.206), respectively, for the oscillating-rotating and sonie brush _2roups (p < 0.001), while the mean reductions in GBI were 0,092 (64.2%6) and 0.062 (43.3%), respectively (p < 0,001). Mean redue- tionsin the number of bleeding sites at Week 8 were 12.83 (63.3%) for the oscillating-rotating brush and 9.00 (44,49) forthe sonic brush, with a between-treatment difference of 3.83 (p < 0.001). Statistically significantly greater reductions were observed for the oscillating-rotating brush versus the sonic brush forall gingivitis ‘measutesat Week 8, with a 34.8%, 48.4% and 42.6% greater reduc tion for MGI, GBI, and number of bleeding sites respectively. Whole Mouth, Gingival Margin, and Proximal RMNPI Seoves At baseline, enrolled subjects presented with a whole mouth RMNPI > 0.50. No statistically significant between-group differ- fences were demonstrated for whole mouth, gingival margin, or prox- ‘The Journal of Clinical Dentistry Vol. XXIX, No.1 imal RMNPI scores (p = 0.546, p = 0.096, and p = 0.223, respec- tively), At Week 8 statistically significant reductions in whole mouth, gingival margin, and proximal region RMNPI scores were observed for both groups (p< 0.001: Table I), Whole mouth plaque reduc- tions for the oscillating-rotating and sonic groups were 24.6% and 19.6%, respectively. Gingival margin and proximal region plaque ») | Py Fire X Rodin (5) bean MGI. GB, ana of edges at Weck ew enone serie retin rach ond te proianane bs lichen assaf, p< 0001. "p00 fa ben rales fering oscil tig dh ‘Table It Mean Baseline and Week § MGI, GBI, and Number of Bleeding Sites Tislne Mean Wek A Mem Changs Teves ou Between (SD)N=150 Reduction SE)N=148 fom Bastin Dilewnae Dine pale Modified Giga index EniryleelO-R brush 2083(00793) 0.445(00127) 165% 039 Mey p< oot Premium soni brish 21056(00029) 10256 00127) Gingival Bleting Index Entry-level OR brs (1138 00800) 020005) oun ow 48.49% p< oan Premium sonics 018501296) ‘05240003 am amber of Beating Sites Entry-level O-R brash 2.28 10503) ass(oauy 3% a3 ne p

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