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The purpose of this investigation was to compare the levels of serum IgG2, the frequency of detection of Gm(23)-negative allotype and frequency of detection of FcγRIIa and FcγRIIIb receptor haplotypes in 32 refractory, 54 successfully treated and 27 periodontally healthy individuals. Refractory subjects showed mean full mouth attachment loss and/or >3 sites with attachment loss >2.5 mm within 1 year after both scaling and root planing, and surgery plus systemically administered tetracycline. Successfully treated subjects showed mean attachment level gain and no sites with attachment loss >2.5 mm 1 year post-therapy. Periodontally healthy subjects exhibited no pocket depth or attachment level >3 mm, and no evidence of progressing disease during 1 year of monitoring. Blood was obtained from each subject at baseline. Serum IgG2 and Gm(23) allotype were determined using radial immunodiffusion. DNA was extracted from whole blood and the FcγR genotypes determined using PCR and allele specific oligonucleotide probes. Significance of differences among clinical groups were sought using the Kruskal-Wallis or chi-square tests. Associations between 2 or more variables were tested using regression analysis. Refractory subjects exhibited higher mean attachment loss and pocket depth than successfully treated or periodontally healthy subjects. Smoking status did not differ significantly among groups. No significant differences in serum IgG2 levels and frequency of detection of Gm(23)-negative allotype were observed among the clinical groups. Serum IgG2 level was positively associated with the number of serum antibody responses to subgingival species (r=0.51, p<0.001). Subjects with the Gm(23)-negative allotype exhibited lower mean levels of serum IgG2 (3.06±0.3 versus 3.9±0.2, p<0.01) and mean number of serum antibodies to subgingival species (17.7±1.7 versus 23.3±1.4, p<0.05) than allotype positive individuals. No significant differences in FcγR haplotype distribution were observed among the 3 clinical groups. Associations of serum IgG2 level, Gm(23) allotype, FcγRIIa and FcγRIIIb receptor haplotypes and smoking status were weakly related or not related to clinical status. This lack of relationship may have been due to a reality of no relationship, or the inadvertent pooling of subjects where these factors were of primary importance with subjects in whom these factors played a less important role. [ABSTRACT FROM AUTHOR]

Background: Periodontal disease is among the sixth most common inflammatory diseases worldwide with high risk to promote complications from other inflammatory diseases including diabetes, cardiovascular disease and Alzheimer's Disease. Failure of active resolution of inflammation pathways is implicated in pathogenesis of periodontal diseases, including gingivitis. Lipoxin A4 (LXA4), a member of the specialized pro-resolving lipid mediators (SPMs) that drive resolution of inflammation via GPC-receptor mediated pathways, offered therapeutic advantages in preclinical models of periodontitis., Methods: We conducted a randomized, placebo-controlled, parallel-group Phase 1 clinical trial to determine the safety and preliminary efficacy of an LXA4 analog in patients with gingival inflammation. One hundred twenty-seven (127) individuals were randomized to daily use of an oral rinse containing a LXA4 mimetic, methyl ester-benzo-lipoxin A4 (BLXA4), placebo rinse or a no-rinse control group for 28 days. Treatment emergent adverse events (TEAEs) were assessed for safety, the primary outcome. Secondary outcomes included the change in the level of gingival inflammation and periodontal pocket depth (PD). Serum SPMs were monitored using targeted lipid mediator lipidomics to assess potential systemic impact of BLXA4., Results: The frequency of TEAEs was similar in BLXA4 and placebo-treated groups with no study-related SAEs. Once-daily rinsing with BLXA4 for 28-days resulted in a greater decrease in gingival inflammation compared to placebo rinse and no-rinse control groups (mean change: 0.26 GI unit vs 0.21 and 0.17, respectively). PD reduction was also greater with BLXA4 oral rinse compared to placebo and no-rinse groups (mean reduction: 1.23 mm vs . 0.71 mm and 0.46 mm, respectively). Topical application of BLXA4 increased serum levels of SPMs., Conclusion: Treatment with BLXA4 reduces local inflammation, and increases abundance of pro-resolution molecules systemically, which may dampen inflammation that can mediate progression and course of inflammatory diseases beyond periodontitis., Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT02342691)., Competing Interests: HH and TD are inventors on several granted and pending licensed and unlicensed patents awarded to the Forsyth Institute that are subject to consulting fees and royalty payments. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Hasturk, Schulte, Martins, Sherzai, Floros, Cugini, Chiu, Hardt and Van Dyke.)

Background: A 6-week Phase I clinical trial was performed to primarily evaluate the safety and secondarily determine the preliminary efficacy of a novel biological solution, ST266, comprised of a mixture of cytokines, growth factors, nucleic acids, and lipids secreted by cultured amnion-derived multipotent progenitor cells on gingival inflammation., Methods: Fifty-four adults with gingivitis/periodontitis were randomly assigned to 1X ST266 or diluted 0.3X ST266 or saline topically applied on facial/lingual gingiva (20 µL/tooth). Safety was assessed through oral soft/hard tissue exam, adverse events, and routine laboratory tests. Efficacy was assessed by modified gingival index (MGI), bleeding on probing, plaque index, probing depth (PD), and clinical attachment level (CAL). Assessments were performed on day 0, 8, 12, and 42. ST266 and saline applied daily starting at day 0 through day 12 except weekend days. Plasma was analyzed for safety and proinflammatory cytokines, interleukin (IL)-1β, IL-6, tumor necrosis factor-alpha, and interferon gamma. Gingival crevicular fluid (GCF) was analyzed for the same cytokines. Subgingival plaque was primarily analyzed by checkerboard DNA-DNA hybridization. Comparisons with saline were modeled through a generalized estimating equations method adjusting for baseline., Results: No safety concern was found related to ST266. Statistically significant reduction in MGI was noted at day 42 by 1X ST266 compared with saline (P = 0.044). PD and CAL were reduced by both doses of ST266 at day 42 (P <0.01) and by 1X ST266 at day 12 (P <0.05). GCF IL-1β and IL-6 levels were reduced by both doses of ST266 at day 12 (P <0.05, P <0.01, respectively). IL-6 was also significantly reduced in plasma of both ST266 groups (P <0.05). Significant reductions in red complex bacteria were detected in both ST266 doses., Conclusions: In this "first in human oral cavity" study, topical ST266 was safe and effective in reducing gingival inflammation in 6 weeks. Longitudinal studies with large sample sizes are warranted to assess the therapeutic value of this novel host modulatory compound in the treatment of periodontal diseases., (© 2021 The Authors. Journal of Periodontology published by Wiley Periodicals LLC on behalf of American Academy of Periodontology.)

Aim: The goal of the present longitudinal cohort study was to examine patterns of periodontal disease progression at progressing sites and subjects defined based on linear mixed models (LMM) of clinical attachment loss (CAL)., Materials and Methods: A total of 113 periodontally healthy and 302 periodontitis subjects had their CAL calculated bimonthly for 12 months. LMMs were fitted for each site and the predicted CAL levels used to categorize their progression state. Participants were grouped based on the number of progressing sites into unchanged, transitional and active subjects. Patterns of periodontal disease progression were explored using descriptive statistics., Results: Progression occurred primarily at molars (50% of progressing sites) and inter-proximal sites (72%), affected a higher proportion of deep than shallow sites (2.7% versus 0.7%), and pocketing was the main mode of progression (49%). We found a low level of agreement (47%) between the LMM and traditional approaches to determine progression such as change in CAL ≥3 mm. Fourteen per cent of subjects were classified as active and among those 93% had periodontitis. The annual mean rate of progression for the active subjects was 0.35 mm/year., Conclusion: Progressing sites and subjects defined based on LMMs presented patterns of disease progression similar to those previously reported in the literature., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Type II diabetes (T2D) has been associated with changes in oral bacterial diversity and frequency. It is not known whether these changes are part of the etiology of T2D, or one of its effects., Methods: We measured the glucose concentration, bacterial counts, and relative frequencies of 42 bacterial species in whole saliva samples from 8,173 Kuwaiti adolescents (mean age 10.00 ± 0.67 years) using DNA probe analysis. In addition, clinical data related to obesity, dental caries, and gingivitis were collected. Data were compared between adolescents with high salivary glucose (HSG; glucose concentration ≥ 1.0 mg/d, n = 175) and those with low salivary glucose (LSG, glucose concentration < 0.1 mg/dL n = 2,537)., Results: HSG was associated with dental caries and gingivitis in the study population. The overall salivary bacterial load in saliva decreased with increasing salivary glucose concentration. Under HSG conditions, the bacterial count for 35 (83%) of 42 species was significantly reduced, and relative bacterial frequencies in 27 species (64%) were altered, as compared with LSG conditions. These alterations were stronger predictors of high salivary glucose than measures of oral disease, obesity, sleep or fitness., Conclusions: HSG was associated with a reduction in overall bacterial load and alterations to many relative bacterial frequencies in saliva when compared with LSG in samples from adolescents. We propose that hyperglycemia due to obesity and/or T2D results in HSG and subsequent acidification of the oral environment, leading to a generalized perturbation in the oral microbiome. This suggests a basis for the observation that hyperglycemia is associated with an increased risk of dental erosion, dental caries, and gingivitis. We conclude that HSG in adolescents may be predicted from salivary microbial diversity or frequency, and that the changes in the oral microbial composition seen in adolescents with developing metabolic disease may the consequence of hyperglycemia.

Aim: The goal of this study was to identify progressing periodontal sites by applying linear mixed models (LMM) to longitudinal measurements of clinical attachment loss (CAL)., Methods: Ninety-three periodontally healthy and 236 periodontitis subjects had their CAL measured bi-monthly for 12 months. The proportions of sites demonstrating increases in CAL from baseline above specified thresholds were calculated for each visit. The proportions of sites reversing from the progressing state were also computed. LMM were fitted for each tooth site and the predicted CAL levels used to categorize sites regarding progression or regression. The threshold for progression was established based on the model-estimated error in predictions., Results: Over 12 months, 21.2%, 2.8% and 0.3% of sites progressed, according to thresholds of 1, 2 and 3 mm of CAL increase. However, on average, 42.0%, 64.4% and 77.7% of progressing sites for the different thresholds reversed in subsequent visits. Conversely, 97.1%, 76.9% and 23.1% of sites classified as progressing using LMM had observed CAL increases above 1, 2 and 3 mm after 12 months, whereas mean rates of reversal were 10.6%, 30.2% and 53.0% respectively., Conclusion: LMM accounted for several sources of error in longitudinal CAL measurement, providing an improved method for classifying progressing sites., (© 2016 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.)

Objective: Here, we investigated the relationships between obesity and the salivary concentrations of insulin, glucose, and 20 metabolic biomarkers in Kuwaiti adolescents. Previously, we have shown that certain salivary metabolic markers can act as surrogates for blood concentrations., Methods: Salivary samples of whole saliva were collected from 8,317 adolescents. Salivary glucose concentration was measured by a high-sensitivity glucose oxidase method implemented on a robotic chemical analyzer. The concentration of salivary insulin and 20 other metabolic biomarkers was assayed in 744 randomly selected saliva samples by multiplexed bead-based immunoassay., Results: Obesity was seen in 26.5% of the adolescents. Salivary insulin predicting hyperinsulinemia occurred in 4.3% of normal-weight adolescents, 8.3% of overweight adolescents, and 25.7% of obese adolescents (p < 0.0001). Salivary glucose predicting hyperglycemia was found in only 3% of obese children and was not predictive (p = 0.89). Elevated salivary glucose and insulin occurring together was associated with elevated vascular endothelial growth factor and reduced salivary interleukin-12., Conclusion: Considering the surrogate nature of salivary insulin and glucose, this study suggests that elevated insulin may be a dominant sign of metabolic disease in adolescent populations. It also appears that a proangiogenic environment may accompany elevated glucose in obese adolescents.

Background: Binary definitions of the metabolic syndrome based on the presence of a particular number of individual risk factors are limited, particularly in the pediatric population. To address this limitation, we aimed at constructing composite and continuous metabolic syndrome scores (cmetS) to represent an overall measure of metabolic syndrome (MetS) in a large cohort of metabolically at-risk children, focusing on the use of the usual clinical parameters (waist circumference (WC) and systolic blood pressure (SBP), supplemented with two salivary surrogate variables (glucose and high density lipoprotein cholesterol (HDLC). Two different approaches used to create the scores were evaluated in comparison., Methods: Data from 8,112 Kuwaiti children (10.00 ± 0.67 years) were used to construct two cmetS for each subject. The first cmetS (cmetS-Z) was created by summing standardized residuals of each variable regressed on age and gender; and the second cmetS (cmetS-PCA) was defined as the first principal component from gender-specific principal component analysis based on the four variables., Results: There was a graded relationship between both scores and the number of adverse risk factors. The areas under the curve using cmetS-Z and cmetS-PCA as predictors for severe metabolic syndrome (defined as the presence of ≥3 metabolic risk factors) were 0.935 and 0.912, respectively. cmetS-Z was positively associated with WC, SBP, and glucose, but inversely associated with HDLC. Except for the lack of association with glucose, cmetS-PCA was similar to cmetS-Z in boys, but had minimum loading on HDLC in girls. Analysis using quantile regression showed an inverse association of fitness level with cmetS-PCA (p = 0.001 for boys; p = 0.002 for girls), and comparison of cmetS-Z and cmetS-PCA suggested that WC and SBP were main contributory components. Significant alterations in the relationship between cmetS and salivary adipocytokines were demonstrated in overweight and obese children as compared to underweight and normal-weight children., Conclusion: We have derived continuous summary scores for MetS from a large-scale pediatric study using two different approaches, incorporating salivary measures as surrogate for plasma measures. The derived scores were viable expressions of metabolic risk, and can be utilized to study the relationships of MetS with various aspects of the metabolic disease process.

Objective: The study of obesity-related metabolic syndrome or Type 2 diabetes (T2D) in children is particularly difficult because of fear of needles. We tested a non-invasive approach to study inflammatory parameters in an at-risk population of children to provide proof-of-principle for future investigations of vulnerable subjects., Design and Methods: We evaluated metabolic differences in 744, 11-year old children selected from underweight, normal healthy weight, overweight and obese categories by analyzing fasting saliva samples for 20 biomarkers. Saliva supernatants were obtained following centrifugation and used for analyses., Results: Salivary C-reactive protein (CRP) was 6 times higher, salivary insulin and leptin were 3 times higher, and adiponectin was 30% lower in obese children compared to healthy normal weight children (all P<0.0001). Categorical analysis suggested that there might be three types of obesity in children. Distinctly inflammatory characteristics appeared in 76% of obese children while in 13%, salivary insulin was high but not associated with inflammatory mediators. The remaining 11% of obese children had high insulin and reduced adiponectin. Forty percent of the non-obese children were found in groups which, based on biomarker characteristics, may be at risk for becoming obese., Conclusions: Significantly altered levels of salivary biomarkers in obese children from a high-risk population, suggest the potential for developing non-invasive screening procedures to identify T2D-vulnerable individuals and a means to test preventative strategies.

Objective: To evaluate the relationship of children's obesity and dental decay., Methods: We measured parameters related to obesity and dental decay in 8,275 4(th) and 5(th) grade Kuwaiti children (average age = 11.36 years) in a cross-sectional study. First to determine body weight, height, age for computation of BMI . Second, to determine numbers of teeth, numbers of fillings and numbers of untreated decayed teeth to determine extent and severity of dental disease. From these measurements, we computed measures of dental decay in children from four body weight categories; obese, overweight, normal healthy weight and underweight children., Results: The percentage of children with decayed or filled teeth varied inversely with the body weight category. The percentage of decayed or filled teeth decreased from 15.61% (n=193) in underweight children, to 13.03% (n=4,094) in normal healthy weight children, to 9.73% (n=1,786) in overweight children to 7.87% (n=2,202) in obese children. Differences between all groups were statistically significant. Male children in this population had more dental decay than female children but the reduction of tooth decay as a function of BMI was greater in male children., Conclusions: The finding of an inverse obesity-dental decay relationship contradicts the obesity-sugar and the obesity-dental decay relationship hypotheses. Sugar is well recognized as necessary and sufficient for dental decay. Sugar is also hypothesized to be a leading co-factor in obesity. If the later hypothesis is true, one would expect dental decay to increase with obesity. This was not found. The reasons for this inverse relationship are not currently clear.

Aim: The aim of this article is to provide a review of common power toothbrush technologies with a focus on the oscillating-rotating motion used in a novel toothbrush; describe features to drive compliance such as the "SmartGuide" innovation; and finally recommend steps to motivate patients to adopt a power toothbrush as part of their home care regimen., Background: Contemporary power toothbrushes are available with various modes of actions, bristle designs, and features. Clinical research shows these factors can impact the effectiveness of a toothbrush by altering its ability to remove plaque, particularly in areas that are difficult to access. An independent systematic review of power toothbrush technologies showed toothbrushes with a rotation-oscillation motion provided significant advantages over manual toothbrushes for plaque removal and gingivitis reduction. No other powered toothbrush technology showed results as consistently superior to manual toothbrushes., Conclusions: Recently, an advanced oscillating-rotating toothbrush was introduced, the Oral-B Triumph with SmartGuide (Procter & Gamble, Cincinnati, OH, USA), using clinically proven oscillating-rotating technology and incorporating a unique wireless remote display to drive good brushing technique and increase brushing time. This type of innovation in power toothbrush technology provides dental professionals and consumers with additional home care tools to help improve oral health. In recommending any power toothbrush, dental professionals should reinforce the benefits to patients in a way that addresses their values, use experiential learning tools to ensure they understand how to use the brush, explain the desired outcomes, and gain their commitment to comply with the recommendation.

Objective: To evaluate the safety and plaque removal efficacy of an advanced rotating-oscillating power toothbrush relative to a sonic toothbrush with either a standard or compact brush head., Methodology: Two studies used a randomized, examiner-blind, two-treatment, crossover design. In Study 1, subjects were instructed to use their first randomly assigned toothbrush for five to seven days and then, after abstaining from all oral hygiene for 24 hours, were assessed with the Rustogi, et al. Modified Navy Plaque Index. They then brushed for two minutes and post-brushing plaque scores were recorded. Subjects were assigned to the alternate toothbrush and the procedures were repeated. In Study 2, subjects alternated using both brushes for approximately 10 days, then had four study visits three to four days apart (some variability based on patient scheduling). In Study 1, Oral-B Triumph with a FlossAction brush head and Sonicare Elite 7300 with a full-size, standard head were compared in a two-treatment, two-period crossover study. Study 2 compared Oral-B Triumph with a FlossAction brush head and Sonicare Elite 7300 with a compact head in a two-treatment, four-period crossover study., Results: Fifty subjects completed Study 1 and 48 completed Study 2. All brushes were found to be safe and significantly reduced plaque after a single brushing. In Study 1, Oral-B Triumph was statistically significantly (p < 0.001) more effective in plaque removal than Sonicare Elite 7300 with the full-size brush head: whole mouth = 24% better, marginal = 31% better, approximal = 21% better. In Study 2, Oral-B Triumph was statistically significantly (p < 0.001) more effective than Sonicare Elite 7300 with the compact brush head: whole mouth = 12.2% better, marginal = 14.6% better, approximal = 12% better., Conclusion: Oral-B Triumph with its rotation-oscillation action was significantly more effective in single-use plaque removal than Sonicare Elite 7300 with its side-to-side sonic action when fitted with either a standard or a compact brush head.

Objective: To assess the plaque removing efficacy and safety of a novel manual toothbrush (Oral-B Pulsar-PUL) compared to leading manual and battery toothbrushes., Methodology: Three clinical studies were conducted, each having a randomized, examiner-blind, crossover design. Study 1 compared PUL to a newly marketed manual toothbrush, Colgate 360 degrees (COL), Study 2 compared PUL to the Oral-B Advantage Plus (AP) and Oral-B CrossAction (CA) manual toothbrushes, and Study 3 compared PUL to two battery toothbrushes, Oral-B CrossAction Power (CAP) and Crest SpinBrush Pro (SBP). Before each brushing visit, subjects refrained from all oral hygiene procedures for 23-25 hours, received an oral tissue examination, and pre-brushing plaque was scored based on the Rustogi et. al, odified Navy Plaque Index. After subjects brushed with the assigned toothbrush in their usual manner for one minute, oral tissues were then re-examined and post-brushing plaque scores recorded. Subjects with pre-brushing whole mouth mean plaque scores > or = 0.6 continued in the study after the first visit. Following a brief washout period between additional visits, the above procedures were repeated in the remaining treatment periods. The examiners who made all clinical measurements were blinded to the treatment sequence., Results: All toothbrushes significantly (p = 0.0001) reduced plaque levels from all areas after a single brushing. Study 1 showed a significant difference for PUL in all areas, whole mouth, margin, and approximal (p < 0.05) compared to COL. In Study 2, PUL removed significantly more whole mouth (p < 0.01) and approximal plaque (p < 0.005) than AP as scored by two examiners, but did not show a significant advantage versus CA. In Study 3, PUL removed significantly more plaque than CAP and SBP for whole mouth (both p = 0.0001), marginal (both p = 0.0001), and approximal (p < 0.005, p = 0.0001, respectively) areas. All toothbrushes were found to be safe with no evidence of hard or soft tissue trauma., Conclusion: The new Oral-B Pulsar toothbrush removed significantly more plaque than Colgate 360 and Oral-B Advantage Plus. Additionally, Pulsar removed significantly more plaque than two battery brushes, Oral-B CrossAction Power and Crest SpinBrush Pro.

Background: The Rustogi et al. Modified Navy (RMNPI) and Turesky et al Modification of the Quigley Hein (TQHPI) plaque indices are commonly used to measure plaque removal. This study evaluated the possible correlations of both indices using data relative to a single use assessment of plaque removal using commercially available toothbrushes., Methods: Single use crossover study designs have been previously reported. Disclosed plaque was scored pre- and post-brushing using both the RMNPI and the TQHPI. Sixty subjects, with an initial mean RMNPI score of 0.6 or greater, were enrolled and completed the study. No minimum score was required for TQHPI. After the initial scoring, the order for each index was randomized so that each subject was scored with either RMNPI followed by TQHPI or vice versa. Two manual toothbrushes [Oral-B CrossAction (CA) and Colgate Navigator (NA)] and one battery-powered brush (Crest SpinBrush Pro) (SBP) were evaluated in the trial. One examiner performed all clinical measurements. Pearson correlations were performed on whole mouth, buccal, and lingual plaque scores for the CA toothbrush., Results: Strong positive correlations were found between the two plaque indices for pre- and post-brushing scores for the whole mouth and on lingual and buccal surfaces, where Pearson correlation coefficients ranged between 0.963 and 0.995. There was no correlation between the pre-brushing plaque score and the amount of plaque removed by brushing indicating that higher plaque levels before brushing do not necessarily predict that greater amounts of plaque will be removed during toothbrushing. Each toothbrush was found to be safe and significantly reduced plaque levels after a single brushing (t-test, p=0.0001). Significantly greater plaque reductions were found with the CA than the NA and SBP toothbrushes at whole mouth, lingual, and approximal surfaces for both indices (analysis of variance (ANOVA), p < or = 0.0002 for all comparisons)., Conclusions: Strong positive correlations were found between two plaque indices (the RMNPI and TQHPI) for pre- and post-brushing scores at whole mouth, lingual, and buccal surfaces as assessed using data from a single use assessment of plaque removal. Efficacy data from this study demonstrated the CA toothbrush provided superior cleaning when compared to the NA manual toothbrush and SBP battery toothbrush., Clinical Implications: Two commonly used indices for assessing plaque removal in clinical studies are RMNPI and TQHPI. However, each index differs in the way plaque is scored. This study used both indices to assess comparative toothbrush efficacy and showed a strong correlation between indices for both pre- and post- brushing plaque scores. The result suggests that both indices demonstrate sufficient sensitivity to differentiate toothbrush efficacy.

The design of the modern conventional manual toothbrush can be attributed to Dr. Robert Hutson, a Californian periodontist, who in the early 1950s developed the multitufted, flattrimmed, end-rounded nylon filament brush that became known as the Oral-B manual toothbrush. The trademark Oral-B emphasized that this was an oral brush, designed to clean all parts of the oral cavity, not merely a toothbrush. Flat-trimmed conventional toothbrushes based on the original Oral-B design have good plaque-removing capability when used carefully. However, limitations in terms of patients" brushing technique and brushing time necessitated a radical change in bristle pattern to improve performance, especially at approximal sites and along the gumline., Rationale for Product Development: Detailed studies of the tooth-brushing process, using advanced scientific and ergonomic research methods, led to new toothbrush designs intended to maximize the efficacy of brushing efforts. These studies showed that the point of greatest interproximal penetration occurs when the direction of brushing changes; bristles angle back into the interproximal space, moving down and back up the adjoining approximal surface. These mechanics were further optimized on the basis of standardized evaluations of brush-design characteristics, including combinations of tuft lengths, insertion angles and tuft layout. With conventional vertical bristles these improvements yield limited benefits because only a few bristles are correctly positioned at the interproximal junction when the brush changes direction. Ultimately, a design with bristle tufts arranged at 16 masculine from vertical along the horizontal brush head axis was identified, in which the maximum number of bristles operated at the optimum angle throughout the brushing cycle. This design was significantly more effective (p < 0.001) than others in terms of penetration (by 9.6%) and cleaning effectiveness per brush stroke (by 15.5%)., Effectiveness: This discovery paved the way for a new toothbrush design with a unique patented array of tufts, which became known as the Oral-B CrossAction brush. This design was selected for extensive independent studies designed to evaluate plaque removal at the gingival margins and in the approximal areas and longer-term control of gingivitis, relative to current standard designs. In a series of studies (published in 2000), 14 single-brushing comparisons and 2 longer-term studies demonstrated the consistent superiority of the Oral-B CrossAction brush over the equivalent commercial standards. Since then, several additional studies have contributed further positive performance data for the CrossAction brush. Two of the studies demonstrated that plaque removal by this brush was superior to that of 15 other manual toothbrushes, and further investigations contributed similarly positive data. Longer-term data have confirmed superior CrossAction performance and the long-term benefits of improved efficacy, particularly for gingivitis., Discussion: Novel approaches to toothbrush design have produced a toothbrush that, when tested in a large number of clinical studies, has consistently met or exceeded established standards of efficacy. The literature contains a wealth of performance data on various toothbrush designs, but none of these designs shows the year-on-year consistency and reproducibility of the Oral-B CrossAction.

Objectives: To compare the safety and plaque removal efficacy of two oscillating/rotating/pulsating toothbrushes (Oral-B ProfessionalCare 7000 [PC 7000] and Oral-B 3D Excel [3DE]) and a high-frequency toothbrush (Sonicare Advance, Philips Oral Healthcare; SA) in a single-use, examiner-blind, three period crossover study., Methods: After refraining from all oral hygiene procedures for 23-25 hours, subjects received an oral tissue examination and those with pre-brushing whole mouth mean plaque scores > or = 0.6 based on the Rustogi et al. Modified Navy Plaque Index were randomly assigned to treatment sequence. After brushing with the assigned toothbrush and a commercially available dentifrice for 2 minutes, oral tissues were then re-examined and post-brushing plaque scores recorded. Following a brief washout period between two additional visits, the above procedures were repeated with the two alternate toothbrushes. One examiner, blinded to the treatment sequence, performed all clinical measurements., Results: A total of 79 subjects (28 males and 51 females) were enrolled and completed the study. Each toothbrush was found to be safe and significantly reduced plaque levels after a single brushing. The PC 7000 and 3DE were equally more effective in plaque removal than the SA, at all tooth areas, reducing plaque by 59.0%, 59.7% and 51.8%, respectively on whole mouth surfaces, and by 67.5%, 67.8% and 59.4%, respectively on approximal surfaces., Conclusions: The action of the oscillating/rotating/pulsating toothbrushes (Oral-B ProfessionalCare 7000 and Oral-B 3D Excel) was more effective in plaque removal than the high-frequency toothbrush (Sonicare Advance).

Objective: This randomised, examiner-blind parallel group study was designed to evaluate the safety and efficacy of a rechargeable oscillating/pulsating toothbrush (Oral-B ProfessionalCare 7000, Oral-B Laboratories; PC 7000) and a battery-operated toothbrush (Crest SpinBrush Pro, Procter & Gamble Company; SBP) in the reduction of gingivitis, bleeding and plaque over a 3-month period., Methods: After 12-18 hours of no oral hygiene, subjects had oral tissue examinations, and gingival and plaque assessments to determine eligibility in the study. Subjects were stratified and randomised into treatment groups based on initial whole mouth mean plaque (Turesky modification of Quigley Hein Plaque Index) and gingivitis (Löe & Silness Gingival Index) scores and gender. Subjects were instructed to brush twice daily with their assigned toothpaste and toothbrush. Clinical parameters were assessed at baseline, and after 1 and 3 months of use. Within treatment comparisons from baseline were analysed using t-test; between treatment comparisons were analysed using ANOVA., Results: Data were obtained from 92 subjects (PC 7000 n=45; SBP n=47). No significant differences were found in baseline plaque, gingivitis and bleeding between groups. Both treatment groups had significant reductions from baseline in plaque, gingivitis and bleeding scores. PC 7000 demonstrated significantly greater reductions compared to SBP in whole mouth plaque at 1 month: 0.39 +/- 0.43 vs. 0.16 +/- 0.42 and 3 months: 0.32 +/- 0.48 vs. 0.04 +/- 0.41. PC 7000 also demonstrated significant reductions compared to SBP in gingivitis at 3 months for whole mouth: 0.14 +/- 0.09 vs. 0.10 +/- 0.10 and approximal areas: 0.11 +/- 0.08 vs. 0.08 +/- 0.09. There were no significant differences between toothbrushes in bleeding at either time point: Safety examinations revealed no apparent difference in soft and hard tissue abnormalities between groups., Conclusion: The PC 7000 toothbrush demonstrated significantly greater reductions in plaque and gingivitis compared to the SPB over a 3-month period.

OBJECTIVES.: To compare the safety and plaque removal efficacy of two electric toothbrushes, one a rechargeable oscillating/pulsating toothbrush with a small round brush head (Oral-B ProfessionalCaretrade mark 7000; PC 7000), the other a battery-operated toothbrush with a dual moving brush head (Crest(R) SpinBrushtrade mark Pro; SBP). METHODS.: The study had a randomised, examiner-blind, two-arm crossover design. All subjects received an oral prophylaxis and used both toothbrushes on alternating days for a two-week practice period. After abstaining from all oral hygiene procedures for 23-25 hours, subjects received an oral tissue examination and those with pre-brushing whole mouth mean plaque scores >/=0.60 measured by the Rustogi et al. Modified Navy Plaque Index were randomly assigned to treatment sequence. Subjects brushed with their assigned toothbrush for 2 minutes using a commercially available dentifrice. Oral tissues were then re-examined and post-brushing plaque scores recorded. After a brief washout period, the above procedures were repeated with the alternate toothbrush. One examiner, blinded to the treatment sequence, performed all clinical measurements. RESULTS.: A total of 70 subjects (24 males and 46 females) were enrolled and completed the study. Each toothbrush was found to be safe and significantly reduced plaque levels after a single brushing. The PC 7000 was significantly more effective in plaque removal than the SBP at all tooth areas, reducing whole mouth plaque by 61% versus 58% and plaque from approximal surfaces by 69% versus 65%, respectively. CONCLUSIONS.: The action of the oscillating/pulsating toothbrush with a small round brush head, Oral-B ProfessionalCare 7000, is more effective in plaque removal than the battery-operated Crest SpinBrush Pro toothbrush with a larger dual moving brush head.

OBJECTIVES.: To compare the safety and efficacy of an oscillating/pulsating power toothbrush (Oral-B ProfessionalCaretrade mark 7000; PC 7000) fitted with either the standard FlexiSoft (PC 7000/EB17) brush head or the novel Pro Polisher (PC 7000/EB-Prophy) and a high-frequency toothbrush (Philips Sonicare(R) Elite(R); SE), in their relative ability to remove plaque and naturally occurring extrinsic dental stain over a six-week period. METHODS.: This randomised, examiner-blind, parallel group study involved 90 healthy subjects from a general population. All subjects received a baseline plaque (Turesky et al. modified Quigley-Hein Plaque Index), stain (Lobene Stain Index) and tooth shade (VITAPAN(R) Shade Guide) [Vita] assessment and an oral tissue examination. After training in the use of their randomly assigned device, subjects were instructed to brush twice daily for 2 min and returned after 3, 4 and 6 weeks of product use for a repeat of each clinical assessment. RESULTS.: Reductions from baseline in mean plaque and extrinsic dental stain scores were significant at Weeks 3, 4 and 6 in all three treatment groups. By Week 6, mean reductions from baseline in whole mouth plaque scores were 32%, 27% and 14% in the PC 7000/EB-Prophy, PC 7000/EB17 and SE groups, respectively. For the body of the tooth, mean reductions from baseline at Week 6 in total stain were 89%, 89% and 80%, respectively. Between treatment group comparisons consistently revealed that the PC 7000 toothbrush plus the EB-Prophy or EB17 brush head removed significantly more plaque and extrinsic stain (total stain, stain area and stain intensity) than the SE toothbrush at 3, 4 and 6 weeks. The EB-Prophy group had a greater proportion of subjects showing a 2-3+ change in Vita shade scores at each time point compared to the other two brushes; at Week 6 the proportions were 67% in the PC 7000/EB-Prophy group, 30% in the PC 7000/EB17 group, and 7% in the SE group. The PC 7000/EB17, PC 7000/EB-Prophy and the SE were found to be safe as used in the study. CONCLUSIONS.: The oscillating/rotating/pulsating PC 7000 (fitted with either the standard EB17 or novel EB-Prophy brush head) is more effective at removal of plaque and naturally occurring extrinsic tooth stain, and the PC 7000 plus EB-Prophy in the improvement of tooth shade, than the high-frequency SE toothbrush.

Aim: To compare the safety and plaque removal efficacy of an oscillating/ pulsating toothbrush (Professional Care Series, Oral-B Laboratories; PCS) and a high frequency toothbrush (Sonicare Elite, Philips Oral Healthcare; SE)., Methods: The study had a randomised, examiner-blind, crossover design. Sixty-one subjects aged 19-64 years were enrolled. After 23-25 hours of no oral hygiene, subjects received an oral tissue examination and those with pre-brushing whole mouth mean plaque scores > or = 0.60 measured by the Rustogi modified Navy Plaque Index were randomly assigned to treatment sequence. Subjects brushed with their assigned toothbrush for 2 minutes using a commercially available dentifrice. Oral tissues were then re-examined and post-brushing plaque scores recorded. After a brief washout period, the above procedures were repeated with the alternate toothbrush. One examiner blinded to the treatment sequence performed all clinical measurements., Results: All 61 subjects completed the study. Both toothbrushes significantly reduced plaque levels after a single brushing (t-test, p < 0.0001). However, the PCS was significantly more effective than the SE in whole mouth plaque removal and in reducing plaque from marginal, buccal, lingual and approximal surfaces (ANOVA, p < 0.0001). Whole mouth plaque was reduced by 88% versus 61% and approximal plaque by 97% versus 73% for the PCS and SE toothbrushes, respectively. There was no evidence of hard or soft tissue trauma after a single-use of either toothbrush., Conclusion: Based on the findings of this single-use clinical evaluation, the action of the oscillating/ pulsating power toothbrush is more effective at plaque removal than a high frequency power toothbrush.

Purpose: To investigate the safety and efficacy of a novel angled-bristled toothbrush in comparison with three established brushes., Methods: The Oral-B CrossAction Vitalizer toothbrush was compared with two manual toothbrushes, the Oral-B CrossAction and Oral-B Advantage, and the battery-operated Crest SpinBrush Pro brush in three independent single-use, examiner-blind, crossover studies. In each study, over 50 healthy subjects from a normal population brushed with their randomly assigned toothbrush for 1 minute without instruction. Subjects returned after a 1-week washout period and brushed with the alternate toothbrush. At each visit, oral hard and soft tissues and plaque were examined before and after brushing. Plaque was evaluated using the Rustogi Modified Navy Plaque Index., Results: Each tested toothbrush significantly (P=0.0001) reduced plaque levels after a single brushing. However, in all three studies, the CrossAction Vitalizer was significantly (P=0.0001) more effective than the comparator brushes in plaque removal from the whole mouth, the gingival margin and approximal surfaces. All toothbrushes were found to be safe with no evidence of oral hard or soft tissue trauma.

Objective: This study was designed to evaluate the safety and plaque removal efficacy of a tooth wipe (Oral-B Brush-Ups) using a manual toothbrush as a control., Methodology: Twenty-five healthy subjects from a general population were enrolled in this randomized, single-use, crossover study. After 23-25 hours of no oral hygiene, oral hard and soft tissues were examined, and disclosed plaque was scored using the Turesky, et al. modification of the Quigley Hein Plaque Index. Subjects used their randomly assigned product for a timed period of one minute without instruction, after which hard and soft tissues and plaque scores were reassessed. Subjects returned to the clinic after a one-week washout period, and the clinical procedures were repeated before and after use of the alternate product. All clinical measurements were made by one examiner who was masked to treatment sequence., Results: Both the tooth wipe and toothbrush were found to be safe, and significantly reduced plaque levels from whole mouth, facial, and lingual surfaces (p < 0.0001). The toothbrush removed significantly greater plaque than the tooth wipe (p < 0.0001) on whole mouth surfaces (49% vs. 29%), facial surfaces (71% vs. 44%), and lingual surfaces (25% vs. 13%)., Conclusion: The tooth wipe provides an effective method of plaque removal when tooth brushing is not practical.

Objective: To compare the safety and efficacy of a novel battery-operated interdental cleaning device (Oral-B Hummingbird) [ID], fitted with either a flossette or pick attachment, versus hand-held dental floss in the reduction of plaque and gingivitis when combined with manual tooth brushing over a 30-day period., Methodology: This randomized, examiner blind, parallel group study assessed three treatment groups: ID/flossette (ID/F), ID/pick (ID/P), and unwaxed manual dental floss. All groups used the same soft manual toothbrush and toothpaste. The 84 subjects were stratified to treatment groups based on initial whole mouth mean plaque scores, gingivitis scores, and gender. Subjects were instructed to brush twice daily and use their assigned interdental method once daily in the evening before brushing. Gingivitis, gingival bleeding, and plaque were evaluated at baseline and Day 30., Results: A total of 78 subjects completed all aspects of the study and were included in the analyses. There was no significant difference between treatment groups in baseline plaque, gingivitis, and bleeding scores. After 30 days, statistically significant reductions from baseline gingivitis and bleeding scores were found for all groups (p < 0.0001), but there were no significant statistical differences among groups. Whole mouth and approximal plaque scores were significantly reduced from baseline in the manual floss and ID/F groups after 30 days of product use, with no significant difference between groups. Plaque reduction for both the manual floss and ID/F groups was significantly greater than the ID/P group. All interdental cleaning methods were safe as used in the study, with no evidence of oral hard or soft tissue trauma., Conclusion: The Oral-B Hummingbird was safe and effective in reducing approximal plaque and gingival inflammation, and provides a useful alternative device for interdental cleaning.

Objective: Limited evidence has suggested that a worn toothbrush may be significantly less effective than a new brush with respect to plaque removal. Two independent studies, one with a manual toothbrush and one with a powered toothbrush, were undertaken to compared the ability of these toothbrushes as new and after three months' use to remove plaque., Methodology: Subjects from a general population were given either an Oral-B CrossAction manual toothbrush (Study 1) or a Braun Oral-B Battery (D4) toothbrush (Study 2). They were instructed to use their respective toothbrushes twice per day for a period of three months. After this time, those subjects meeting the studies' respective inclusion criteria entered the single-use, cross-over phase of the two studies. Both studies involved disclosing the teeth prior to measuring plaque. In Study 1, plaque was recorded using the Proximal Marginal Plaque Index and subjects brushed for one minute, by random assignment, with either a new or a worn toothbrush. In Study 2, plaque was measured using the Modified Quigley-Hein Plaque Index and subjects brushed for two minutes with either new or used brush heads, by random assignment. After a period of approximately one week, subjects returned to the test facilities and brushed with the alternate brush., Results: Study 1 showed that both the new and the worn CrossAction toothbrushes significantly reduced plaque scores (p < 0.0001). A comparison of the two toothbrushes revealed no significant difference for whole-mouth plaque scores; however, at approximal sites the new toothbrush was significantly more effective than the worn brush (p = 0.033). In Study 2, as in Study 1, brushing with either a new or a worn brush head significantly reduced plaque scores (p < 0.0001). A comparison of the efficacies of the new and worn D4 toothbrushes revealed a non-significant tendency for the new brush head to remove more plaque than the worn brush head. However, when plaque removal was assessed for subjects using brush heads with the most extreme wear, i.e., scores of 3 or 4 (n = 15), a significant difference (p < 0.05) between new and worn brush heads was observed for the whole-mouth and approximal surfaces., Conclusion: The results from these two studies provide further data in support of the hypothesis that a worn toothbrush is less efficient with respect to plaque removal than a new brush. Patients should therefore be encouraged to replace their toothbrush regularly before bristle wear becomes excessive.

Purpose: To compare the safety and efficacy of two recently introduced modern power toothbrushes with different characteristics., Materials and Methods: This was a single-blind, randomized, crossover study which compared the ability of two power toothbrushes to remove plaque during a 2-minute brushing period. The two brushes were the Braun Oral-B 3D Excel (D17), a rechargeable toothbrush with an oscillating/rotating/pulsating action and the Colgate Actibrush, a battery-operated device with an oscillating/rotating action. Seventy-four healthy subjects from a general population who met the inclusion/exclusion criteria used the two brushes on alternate days for a period of familiarization before returning to the test facility. At this visit, subjects with a whole mouth mean Proximal/Marginal Plaque Index of > or = 2.20 after 23-25 hours of no oral hygiene were randomly assigned to one of two treatment sequences, D17/Actibrush and Actibrush/D17, balanced for age and gender. Subjects brushed with their assigned toothbrush after which post-brushing plaque scores were recorded. After a 2-week washout phase subjects returned to the test facility and brushed with the alternate toothbrush as described. Data from the two visits were pooled, after which plaque removal efficacies were compared. Change from prebrushing treatment means were compared using ANOVA with models appropriate for the crossover design., Results: Both toothbrushes were found to be safe and both significantly reduced plaque levels (P < or = 0.0001), but the D17 was significantly more effective than the Actibrush for the whole mouth and for approximal sites. Plaque reductions for the D17 were 46.5%, 55.2% and 42.9% for whole mouth, marginal and approximal sites, respectively while reductions for the Actibrush for the whole mouth, marginal, and approximal sites, were 41.5%, 52.5% and 36.8% respectively. It is concluded that the Braun Oral-B D17 may offer advantages in terms of plaque removal over the battery-powered Actibrush, particularly at hard to reach approximal sites.

Background: Reports suggest powered toothbrushing may provide some clinical benefit 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 benefits 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-flossing gingivitis population (n = 157). Subjects were given written instructions but no demonstration on toothbrush use at baseline. Efficacy was assessed by changes in gingival inflammation, plaque, calculus, and stain, while changes in clinical attachment levels and recession measurements provided safety data. A prophylaxis was provided after baseline 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 inflammation showed a statistically significant drop for both brushes at 3 and 6 months. Mean overnight full-mouth PI scores were significantly 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 significantly 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 significant differences in stain were observable. Clinical attachment level and recession measurements showed no significant 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.

Purpose: To compare the safety and efficacy with respect to the control of calculus and stain of two power toothbrushes., Materials and Methods: This was a cross-over study involving a total of 81 subjects from a general population who used, in a randomized sequence, the Braun Oral-B 3D Excel (D17) and the Sonicare toothbrush with a conventional dentifrice, and a manual brush with a tartar control dentifrice. The manual toothbrush with tartar control dentifrice served as a positive control with respect to control of calculus. Following 9 weeks of manual brush use with a conventional, non-abrasive dentifrice, each test brush was used for a period of 9 weeks, after which subjects switched to the next brush in the sequence. Calculus was scored using the Volpe-Manhold Calculus Index and stain using the Lobene Stain Index., Results: All three brushes were found to be safe as used in the study. All three toothbrushes significantly reduced the levels of calculus as compared to the control period. Reduction from baseline in the rate of calculus formation was greatest in the D17 group (63%), followed by the manual brush with tartar control dentifrice (60%) and Sonicare (44%). Both the D17 and the manual brush were significantly more effective than Sonicare (P< 0.001). The D17 was also more effective at controlling stain formation than either Sonicare or the manual brush with tartar control dentifrice at the gingival margin, the difference from Sonicare being statistically significant for all analyses (P< 0.0001). It is concluded that the D17 is significantly more effective in reducing both the rate of calculus and stain formation than the Sonicare toothbrush.

Power toothbrushes can offer significant advantages over a manual toothbrush both with respect to plaque removal and compliance. Most studies have, however, been carried out with adult toothbrushes in adult populations. Less is known about the efficacy of children's power toothbrushes, although it is likely that similar advantages will be demonstrated. This practice based study used the Debris Index (DI) component of the Simplified Oral Hygiene Index to compare baseline oral hygiene with results after 2 months of using the Braun Oral-B Kids' Power Toothbrush (D10). The study involved 13 dental offices and a total of 154 children aged 4 to 9 years. For all sites (facial and lingual), using the D10 for 2 months resulted in an approximately 40% reduction in the DI. Questionnaires completed by the parents or guardians, the children, and the dentists indicated a very favorable response to the power toothbrush. Both parents and children preferred the D10 to a manual toothbrush and most said they would continue to use it. The fact that children found the D10 fun to use may well aid compliance. Dentists thought that the D10 was effective and, at the end of the study, most said that they would now recommend a power toothbrush. It is concluded from the results of this practice based study that the D10 can help to reduce plaque levels in a population of children who previously relied on a manual toothbrush. The fact that the D10 is appealing to children and fun to use should aid compliance with long-term oral hygiene.

Toothbrushes for children have not suited all age groups. The development of a series of children's toothbrushes (Oral-B Stages toothbrushes) targeted at four age-defined groups and designed to meet their needs offers the potential to enhance oral hygiene. To obtain information regarding the specific likes and dislikes of these four children's toothbrushes, a randomized, practice based study involving children between the ages of 4 months and 11 years was conducted. Children were recruited from 25 pediatric dental practices located in the United States, Australia, and Europe. After 1 month of using the brushes, questionnaires were completed by the parents or guardians, children, and dental professionals. Eighty percent to 90% of respondents "liked" or "liked extremely" the toothbrushes with respect to overall like or dislike, cleaning ability, ease of use, and gentleness. Ninety-five percent of the dental professionals in the study concluded that they would recommend these toothbrushes to their patients and 90% thought that the toothbrushes would improve their patients' oral health. It was concluded that the four children's toothbrushes are safe and effective. The design of the brush heads should enhance plaque removal while the ergonomic design of the handles will aid dexterity.