Safety and Preliminary Efficacy of a Novel Host-Modulatory Therapy for Reducing Gingival Inflammation.

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).

Use of amnion-derived cellular cytokine solution for the treatment of gingivitis: A 2-week safety, dose-ranging, proof-of-principle randomized trial.

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)-1ß, 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-1ß 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.

Patterns of periodontal disease progression based on linear mixed models of clinical attachment loss.

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.

The salivary microbiome is altered in the presence of a high salivary glucose concentration.

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.

Unhealthy Phenotype as Indicated by Salivary Biomarkers: Glucose, Insulin, VEGF-A, and IL-12p70 in Obese Kuwaiti Adolescents.

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.

Modelling changes in clinical attachment loss to classify periodontal disease progression.

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.

Continuous Metabolic Syndrome Scores for Children Using Salivary Biomarkers.

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.

Metabolic disease risk in children by salivary biomarker analysis.

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.

Obesity and dental decay: inference on the role of dietary sugar.

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.

Plaque removal efficacy of a novel manual toothbrush with MicroPulse bristles and an advanced split-head design.

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.

A novel oscillating-rotating power toothbrush with SmartGuide: designed for enhanced performance and compliance.

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.

Clinical evaluations of plaque removal efficacy: an advanced rotating-oscillating power toothbrush versus a sonic toothbrush.

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.

Correlations between two plaque indices in assessment of toothbrush effectiveness.

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 Oral-B CrossAction manual toothbrush: a 5-year literature review.

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.

A 30-day clinical comparison of a novel interdental cleaning device and dental floss in the reduction of plaque and gingivitis.

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.

Plaque removal efficacy of a novel tooth wipe.

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.

Plaque removal efficacy and safety of the next generation of manual toothbrush with angled bristle technology: results from three comparative clinical studies.

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.