A randomized controlled trial assessing denture adhesive efficacy on denture retention across 13 hours.

PURPOSE: To compare the effects of two denture adhesive formulations on the bite force required to dislodge a maxillary denture in adult participants during a 13-h test period. MATERIALS AND METHODS: Twenty-two participants with a fair-to-poor fitting maxillary denture opposed by natural dentition or a stable mandibular denture were enrolled in this single-center, randomized, double-blind, two-treatment, 4-period crossover study. Participants were randomly assigned a product usage sequence so that each participant used each product twice during the 4-day test period. The test product was a denture cream adhesive formulated with an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Ultra technology); the control product was a cream adhesive formulated with a calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Original technology). On each study day, bite force at dislodgement was measured with a gnathodynamometer at baseline, representing the "no adhesive" score. Then, after standardized product application to the participant's existing maxillary denture by site staff, bite force measurements were retaken at 1, 3, 5, 7, 9, 11, and 13 h. The change from baseline and the 13-h area under the bite-force-change-from-baseline curve were analyzed via an analysis of variance. RESULTS: Twenty-one participants completed all test periods; one additional participant completed three test periods so 22 participants were included in the analysis. There were 15 females and 7 males with a mean age of 70 years. The mean 13-h area under the bite-force-change-from-baseline curve was 8% greater (p = 0.010) for the test adhesive (114.3 lb) than for the control adhesive (105.9 lb). Both adhesives showed a statistically significant increase in bite force (p < 0.001) at each time point compared to no adhesive. CONCLUSIONS: The optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid test adhesive provided superior maxillary denture retention relative to that of the control adhesive across 13 h. Both adhesives increased bite force at dislodgement compared to no adhesive.

Using Electromagnetic Articulography to Measure Denture Micromovement during Chewing with and without Denture Adhesive.

PURPOSE: To study the effects of denture adhesive upon denture micromovements in three dimensions during the chewing of hard, sticky, and tough food items observed using a novel method involving an electromagnetic articulograph (EMA) speech research system. MATERIALS AND METHODS: Ten volunteers (mean age 60.9 ± 10.4 years) with fair- or poor-fitting complete maxillary dentures were enrolled. Chewing experiments were conducted using two treatments (adhesive or no-adhesive control) and three foods: carrots (hard), raisins (sticky), and processed meat stick (tough). Denture micromovement was measured through a novel application of a Northern Digital Wave EMA System. Three-dimensional denture position was captured during mastication using three sensors embedded into a replica denture for each subject. Following individual characterization of a "home" reference position, the Euclidean Distances from Home (DfH) were calculated for each recorded sample of the chewing experiments. The DfH at each sample represented the denture movement for that 1/100th of a second of the activity. The DfH data were then summarized as the mean DfH, the maximum DfH, and total distance traveled by the denture. Several thresholds were also analyzed, including the percent of time that the DfH ≥1.5 mm, ≥2.0 mm, and ≥2.5 mm. RESULTS: With adhesive treatment, the mean DfH of dentures during chewing was reduced by 26.8% for carrot, 30.3% for raisin, and 31.0% for meat stick, when compared with no-adhesive treatment (p < 0.001 for all comparisons). Similar results were also seen for the maximum DfH and total distance travelled endpoints across foods. For the threshold endpoints, adhesive treatment was associated with a statistically significant reduction in denture micromovements at all three thresholds across foods. At the threshold of DfH ≥ 1.5 mm, adhesive treatment was associated with a reduction in micromovement by 61.6%, 56.2%, and 70.0% with carrot, raisin, and meat stick, respectively (p ≤ 0.004 for all comparisons). CONCLUSIONS: Observations of denture movement using the Wave EMA System were able to differentiate systematically between adhesive treatment and no-adhesive treatment for denture micromovements during different chewing challenges. Use of adhesive was associated with statistically significant reductions in denture micromovements for hard, sticky, and tough foods as measured with both distance and threshold endpoints.

Subgingival uptake and retention of stannous fluoride from dentifrice: Gingival crevicular fluid concentrations in sulci post-brushing.

PURPOSE: To examine the delivery of stannous fluoride to subgingival sulci following toothpaste use in a clinical population. METHODS: This was a controlled, single-site study. 23 subjects with at least 20 dental pockets, 2-4 mm with bleeding, who had not used a stannous fluoride dentifrice in the last 3 months were enrolled. After a 2-week washout period, 20 subjects returned for a baseline visit. They were instructed to refrain from brushing the night before the baseline visit. GCF samples were taken from up to 10 sites identified as sampling sites. Subjects were then given a 0.454% stannous fluoride dentifrice and soft manual toothbrush and asked to brush for 1 minute. 30 minutes after brushing, GCF was re-sampled. Subjects continued using the stannous fluoride dentifrice and soft manual toothbrush at home, twice daily for 2 weeks, in place of their usual hygiene products. At Days 1 and 14, subjects returned to the site, and 12 hours post-brushing GCF samples were taken. The samples were analyzed by ICP-MS (inductively coupled plasma mass spectrometry). A Wilcoxon signed-rank test was performed to determine the difference between post-baseline visits and baseline. Statistical tests were 2-sided using a 5% significance level. RESULTS: 20 subjects completed the trial. Significant levels of tin, a marker for stannous fluoride, were detected 30 minutes after brushing at sampling sites of 2-4 mm. The median tin level in gingival crevicular fluid (GCF) was 24.59 ng/µl, which was highly significant versus baseline (P< 0.0001). Tin levels sampled in GCF 12 hours after brushing on Days 1 and 14 were highly significant versus Baseline (P< 0.0001), showing an increasing trend with continued use. CLINICAL SIGNIFICANCE: Stannous fluoride was found to penetrate sampling sites from 2-4 mm and was retained for 12 hours. Subgingival uptake and retention of stannous fluoride following toothbrushing may play a role in detoxification effects on microbial biofilms and may contribute to the therapeutic efficacy of stannous fluoride dentifrices in promoting gingival health.

Clinical effects of stannous fluoride dentifrice in reducing plaque microbial virulence III: Lipopolysaccharide and TLR2 reporter cell gene activation.

PURPOSE: This study expanded the analysis of subgingival dental plaques from previous research to include the evaluation of cohort, site and treatment effects on chemically measured endotoxin and activation of Toll-like receptor (TLR) based gene expression in two additional reporter cell lines: a TLR2 specific cell line and a THP-1 (multi TLR reporter) cell line. METHODS: Participants from high and low bleeding cohorts were sampled at baseline for both supra and subgingival dental plaque at both healthy as well as clinically diseased sites and then provided with intervention hygiene products including a stabilized SnF2 dentifrice and a new soft bristle manual toothbrush. Following 2 and 4 weeks of assigned dentifrice use, participants returned for a re-evaluation of gingival inflammation and bleeding and repeat samplings of dental plaque. Subgingival sampled plaques were chemically analyzed for endotoxin concentration using a Thermo Scientific Pierce LAL chromogenic endotoxin quantitation kit. Samples were also used for inoculation of two reporter cell assays (an HEK293 TLR2 reporter cell line and a THP-1 monocyte cell line). Reporter cell activation was analyzed via luminescence changes of secreted embryonic alkaline phosphatase. RESULTS: The endotoxin content of subgingival plaque could be measured directly with dye assays and plaque isolates activated gene expression in both TLR reporter cell lines. Higher disease cohorts and sites with gingival inflammation generally showed more endotoxins and higher levels of plaque virulence as compared to low disease cohorts or plaque sampled from clinically healthy sites. SnF2 dentifrice treatment was associated with broad scale reductions in endotoxin content and virulence potentiation properties of dental plaque samples collected subgingivally from patients. CLINICAL SIGNIFICANCE: These results collectively support the use of dye or various reporter cell lines in the characterization of plaque virulence in diseased populations and as a potential route for analysis in clinical evaluations of treatment interventions. Subgingival plaque 'detoxification' including effects on microbial pathogenicity as well as metabolic activity may be considered important mechanisms contributing to clinical benefits of SnF2 dentifrice.

Clinical Effects of Stabilized Stannous Fluoride Dentifrice in Reducing Plaque Microbial Virulence II: Metabonomic Changes.

OBJECTIVES: The clinical effects of stannous fluoride (SnF2) dentifrice in reducing symptoms of gingivitis and reducing the virulence of subgingival plaque through suppression of activation of gene expression in toll receptor based reporter cells were previously reported. This study expanded analysis of the clinical study to include evaluation of dentifrice effects on salivary metabolites using 1H Nuclear Magnetic Resonance (1H NMR) systems biology-based metabonomics. METHODS: The clinical design was reported previously (J Clin Dent2017;28:16-26). Participants included a cohort exhibiting high and low levels of gingival disease as presented at initiation of the study. Participants provided morning lavage saliva samples at baseline. Following this, participants were provided with a hygiene intervention, including a stabilized SnF2 dentifrice and a new soft bristle manual toothbrush. Following two and four weeks of assigned dentifrice use, participants again collected morning lavage saliva samples. Samples were analyzed by 1HNMR spectroscopy on a Bruker 600MHz NMR spectrometer. System-wide analyses were carried out by partial least squared (PLS) comparisons of aggregate spectra, and discrete metabolites with established spectral signatures were likewise directly compared. RESULTS: PLS analysis showed significant differences in saliva composition for saliva collected from high bleeding and low bleeding cohorts. Clear shifts in saliva composition were observed in system-wide PLS analysis following intervention of SnF2 dentifrice for both cohorts. A number of discrete spectral changes were consistently observed with SnF2 dentifrice intervention, most notably including reductions in propionic acid and butyric acid, key short chain fatty acids associated with anaerobic metabolism in dental plaques. CONCLUSIONS: These results collectively demonstrate that SnF2 dentifrice treatment was associated with broad scale modifications in saliva composition following intervention in both high and low diseased cohorts. Changes in overall salivary composition and specific reductions in saliva concentrations of propionic and butyric acid reductions occurred coincident with clinical improvements in gingivitis and gingival bleeding. These results provide support for the hypothesis that the effectiveness of SnF2 dentifrice in improving gingival health is associated with a modification of microbiome metabolism, including suppression of short chain fatty acid metabolites.

Clinical Effects of Stabilized Stannous Fluoride Dentifrice in Reducing Plaque Microbial Virulence I: Microbiological and Receptor Cell Findings.

OBJECTIVES: Lipopolysaccharides (LPSs) and lipoteichoic acids (LTAs), or bacterial endotoxins, bind with Toll-like receptors (TLRs) that are expressed on host cells of the periodontium, thereby contributing to the periodontal pathogenicity of oral bacteria. Stannous fluoride (SnF2), an antibacterial fluoride that treats and controls gingivitis, has been shown to react with lipophilic domains/anionic charges in LPS and LTA. The effects of bacterial species and dental plaque on toll receptors can be studied using genetically engineered cell lines containing linked toll receptors on their surfaces. This randomized, examiner-blinded study examined the clinical effects of stabilized SnF2 dentifrice intervention on gingivitis and dental plaque virulence in populations exhibiting high and low levels of clinical gingivitis. METHODS: Recruited populations were evaluated for gingival inflammation (MGI) and gingival bleeding (GBI) at baseline and assigned into two cohorts of 20 each, those with high (GBI > 20 sites) and low (GBI < 3 sites) levels of observed bleeding/gingivitis. Participants were sampled at baseline for both supra- and subgingival dental plaque at both healthy (no bleeding, PD = 2 mm), as well as clinically diseased sites (bleeding, PD = 3-4 mm), and then provided with an intervention hygiene product including a stabilized SnF2 dentifrice and a new soft bristle manual toothbrush. Following two and four weeks of assigned dentifrice use, participants returned for a re-evaluation of gingival inflammation and bleeding and repeat samplings of dental plaque. Plaque samples were analyzed by anaerobic culturing of gram negative anaerobes (GNA), as well as by incubation of subgingival sampled plaques with TLR4 transfected HEK293 cells, where gene expression was assessed by measurement of a SEAP alkaline phosphatase reporter as a marker of toll receptor activation. RESULTS: Clinical assessments showed statistically significant reductions in MGI (24-26%) and GBI (42-53%) gingivitis in both diseased and healthy cohorts following four weeks of dentifrice intervention. For all clinical examinations, MGI and bleeding sites were statistically significantly different (lower) in the low bleeding versus the higher bleeding cohort. Supragingival and subgingival GNAs were significantly reduced (p < 0.05) in both high and low disease cohorts at bleeding and healthy sites following four weeks of stabilized SnF2 dentifrice use. TLR activation from subgingival sampled plaque was reduced following four weeks of stabilized SnF2 dentifrice use in both high and low disease cohorts and in both healthy, as well as diseased sites. CONCLUSIONS: Collectively, these results support the potential for stabilized SnF2 dentifrice to provide clinical gingivitis benefits via mechanisms beyond control of plaque mass, potentially directly decreasing the pathogenicity of plaque biofilms by blocking reactivity of LPS and LTA ligands with tissue receptors associated with inflammation. Importantly, benefits could be seen in both diseased sites, as well as sites not yet exhibiting symptoms of inflammation, supporting the activity of SnF2 not just in treating diseased sites, but in preventing disease development. These learnings may influence treatment planning for patients susceptible to gingivitis.

Quantitation of endotoxin and lipoteichoic acid virulence using toll receptor reporter gene.

PURPOSE: To apply quantitative Toll-like receptors (TLR) cell assays to compare lipopolysaccharides (LPSs) and lipoteichoic acids (LTAs) from different oral bacterial strains for potential pathogenicity in vitro. METHODS: The potency of LPS and LTA from different bacteria on activation of TLR reporter genes in HEK-tlr cell lines was examined. P. gingivalis LPS mix, P. gingivalis 1690 LPS, P. gingivalis 1435/50 LPS, E. coli LPS (E. coli K12), B. subtilis LTA, S. aureus LTA, E. hirae LTA and S. pyogenes LTA were examined in both TLR2 and TLR4 HEK cell line reporter assays. Solutions of LPS and LTA from selected bacteria were applied in a dose response fashion to the TLR reporter cells under standard culture conditions for mammalian cells. Reporter gene secreted-embryonic-alkaline-phosphatase (SEAP) was measured, and half maximal effective concentration (EC50) was determined for each sample. Concentration dependent TLR activation was compared to similar responses to LPS and LTA for commercial BODIPY-TR-Cadaverine and LAL biochemical (non cell based) assays. RESULTS: All LPS from P. gingivalis activated both TLR2 and TLR4 responses. E. coli LPS is a strong activator for TLR4 but not for TLR2 responses. In contrast, both B. subtilis and S. aureus LTA provoked responses only in TLR2, but not in the TLR4 assay. Interestingly, E. hirae LTA and S. pyogenes LTA did not stimulate strong TLR2 responses. Instead, both E. hirae LTA and S. pyogenes LTA mounted a reasonable response in TLR4 reporter gene assay. Both LPS and LTA showed deactivation of fluorescence in BODIPY-TR-Cadaverine while only LPS was active in LAL. As with biochemical assays, an EC50 could be determined for LPS and LTA from various bacterial strains. The EC50 is defined as a concentration of LPS or LTA that provokes a response halfway between the baseline and maximum responses. Lower EC50 means higher potency in promoting TLR responses, and in principle indicates greater toxicity to the host. CLINICAL SIGNIFICANCE: InvivoGen TLR2 and TLR4 assays distinguish specific types of microbial products, such as LPS and LTA from different bacteria. Application of EC50 determinations creates a means for quantitative and comparisons of LPS and LTA virulence in a cellular-based assay and combinations of TLR reporter cell assays along with biochemical evaluation of LPS#47;LTA in BODIPY-TR-Cadaverine and LPS in LAL assays provides a means to quantitate virulence of plaque samples with respect to both LPS and LTA. These learnings have long-term implications for patient care in that understanding the virulence of patients' plaque provides important information to assess risk of oral diseases.

Lipopolysaccharide and lipoteichoic acid binding by antimicrobials used in oral care formulations.

PURPOSE: To study the reactivity of lipopolysaccharide (LPS) and lipoteichoic acid (LTA) with the cationically charged agents cetylpyridinium chloride, stannous fluoride, and the non-cationic agent triclosan. We also assessed the effect of these agents to inhibit LPS and LTA binding to cellular Toll-like Receptors (TLRs) in vitro. METHODS: The ability of these antimicrobials to bind with LPS and/or LTA was assessed in both the Limulus amebocyte lysate and BODIPY-TR-cadaverine dye assays. Mass spectroscopy was then used to confirm that stannous fluoride directly binds with LPS and to determine stoichiometry. Lastly, we looked for possible inhibitory effects of these antimicrobial agents on the ability of fluorescently conjugated LPS to bind to TLR4 expressed on HEK 293 cells. RESULTS: Cetylpyridinium chloride (CPC) and stannous salts including stannous fluoride interfered with LPS and LTA reactivity in both dye assays, while triclosan had no effect. Mass spectroscopy revealed direct binding of stannous fluoride with E. Coli LPS at 1:1 stoichiometric ratios. In the cellular assay, cetylpyridinium chloride and stannous fluoride, but not triclosan, inhibited LPS binding to TLR4. CLINICAL SIGNIFICANCE: These results support a potential mechanism of action for stannous fluoride and CPC formulated in oral products in which these ingredients bind bacterial toxins and potentially render them less toxic to the host. These results may influence home care recommendations for patients at risk for plaque-related diseases.

Lipopolysaccharide and Lipoteichoic Acid Virulence Deactivation by Stannous Fluoride.

OBJECTIVES: Oral bacterial pathogens promote gingivitis and periodontal disease. Bacterial endotoxins, also known as lipopolysaccharides (LPSs) and lipoteichoic acids (LTAs), are known to enhance bacterial pathogenicity through binding with Toll-like receptors (TLRs), a group of pattern recognition receptors critical to the activation of innate immunity, that are expressed on host cells. Both LPS and LTA contain lipophilic domains and anionic charges that may be susceptible to reactivity with stannous fluoride, a commonly used ingredient clinically proven for the treatment and prevention of gingivitis. This study examined the effects of stannous fluoride on Toll-like receptor activation in response to bacterially derived LPS and LTA in select cell lines and secretion of inflammatory cytokines from human primary peripheral monocytes likewise exposed to LPS. METHODS: TLR4 and TLR2 transfected HEK293 cells and THP1-Dual™ cells were exposed to bacterial LPS and LTA in the presence of increasing concentrations of stannous fluoride. Gene expression was assessed by measurement of secreted embryonic alkaline phosphatase (SEAP) reporter gene for HEK293 cells and SEAP and luciferase for THP-1 cells. Cell viability was confirmed using PrestoBlue. Human primary monocytes were treated with LPS with various concentrations of supplemented stannous fluoride, and cytokine expression was directly measured. RESULTS: Stannous fluoride inhibited gene expression response of TLR4 and TLR2 in HEK293 cells and THP1-Dual™ cells in a dose response fashion, producing complete inhibition at micromolar concentrations. The addition of stannous fluoride suppressed production of TNF-a, IFN-g, IL12p70, IL10, IL-1b, IL2, and IL-6, and also increased secretion of Il-8 in dose response fashion. Viability assays confirmed no effects of LPS or stannous fluoride on viability of HEK293, THP-1, and primary human monocytes. CONCLUSIONS: These results support the potential for stannous fluoride to provide clinical gingivitis benefits by directly decreasing the pathogenicity of plaque biofilms by blocking reactivity of LPS and LTA ligands with tissue receptors associated with inflammation. These learnings may influence recommendations for patients at risk for plaque-related diseases.

Response of chronic gingivitis to hygiene therapy and experimental gingivitis. Clinical, microbiological and metabonomic changes.

PURPOSE: To compare the clinical, microbiological and metabonomic profiles of subjects with high and low levels of chronic gingival bleeding during a controlled oral hygiene regimen intervention including sequential phases of rigorous therapeutic oral hygiene followed by experimental gingivitis (EG). METHODS: Two cohorts of qualified study subjects with differences in gingival bleeding on probing levels at their baseline clinical examination were entered into the study. These two cohorts were followed through three separate study phases including a 1-week baseline phase, a 2-week phase of rigorous oral hygiene including dental prophylaxis, and a 3-week EG phase of no oral hygiene to encourage relapse of gingivitis. The 58 subjects were assessed during each phase of the study for clinical presentation of gingivitis and concurrently had plaque sampled for real-time polymerase chain reaction (RTPCR) microbiological characterization and salivary lavage samples for 'systems biology' metabonomics assessment by 1H-NMR. RESULTS: Subjects presenting with different levels of gingival bleeding on probing when they entered the study responded differently to rigorous oral hygiene and EG. Specifically, the high bleeding cohort responded sluggishly to rigorous oral hygiene and exhibited markedly greater relapse to gingivitis during EG. RTPCR analysis showed changes in bacterial populations that were associated with study phases, particularly the increases in putative periodontal pathogens during EG. However, the microbiological profiles of high- and low-susceptibility gingival bleeding patients were largely similar. Metabonomic analysis likewise revealed significant changes in metabolite composition during study phases associated with differences in plaque toxicity, especially the short chain carboxylic acids propionate and n-butyrate, which tracked clinical changes in gingivitis severity. Systems analysis of metabonomic changes suggested differences between cohorts, although analysis to date has not elucidated whether these differences are causative (population predictive) or simply diagnostic of clinical status within populations.

A 4-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush in reducing dental plaque.

PURPOSE: To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush. METHODS: This study used a randomized, examiner-blind, single-center, two-treatment, parallel group 4-week design. Subjects with pre-existing plaque scores of at least 1.75 on the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) were evaluated for baseline whole mouth and approximal plaque scores. They received either the oscillating-rotating brush (Oral-B Professional Care 1000, sold as Oral-B Professional Care 600 in some regions, with the Oral-B Precision Clean brush head, D16u/EB20) or the sonic brush (Colgate ProClinical C200 with Colgate Triple Clean brush head) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for 4 weeks before returning for plaque measurements. Prior to baseline and the Week 4 measurements, participants abstained from oral hygiene for 12 hours and from eating, chewing gum and drinking for 4 hours. RESULTS: A total of 131 subjects were enrolled in the study at baseline, with all completing the study: 65 in the oscillating-rotating group, and 66 in the sonic group. Both brushes significantly reduced plaque over the 4-week study period. The oscillating-rotating brush was statistically significantly more effective in reducing plaque (P < 0.001) than the sonic brush. Compared to the sonic power brush, the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas.

A randomized clinical trial evaluating gingivitis and plaque reduction of an oscillating-rotating power brush with a new brush head with angled bristles versus a marketed sonic brush with self-adjusting technology.

PURPOSE: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head) versus a marketed sonic toothbrush (Colgate ProClinical A1500 with the Triple Clean brush head) in the reduction of gingivitis and plaque over a 6-week period. METHODS: This was a single center, randomized, open label, examiner-blind, 2-treatment, parallel group study. Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups. Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks. Gingivitis and plaque were evaluated at baseline and Week 6. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data was analyzed using the ANCOVA with baseline as the covariate. RESULTS: In total, 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study. Both brushes produced statistically significant (P < 0.001) reductions in gingivitis and plaque measures relative to baseline. The oscillating-rotating,brush with the novel brush head demonstrated statistically significantly (P < 0.05) greater reductions in all gingivitis measures, as well as whole mouth and interproximal plaque measures, compared to the sonic toothbrush. The benefit for the oscillating- rotating brush over the sonic brush was 21.3% for gingivitis, 35.7% for gingival bleeding, 34.7% for number of bleeding sites, 17.4% for whole mouth plaque, and 21.2% for interproximal plaque. There were no adverse events reported or observed for either brush.

Comparative bioavailability and antimicrobial activity of cetylpyridinium chloride mouthrinses in vitro and in vivo.

PURPOSE: Commercialized cetylpyridinium chloride (CPC) mouthrinses were compared for antimicrobial substantivity/bioavailability in an in vitro disk retention assay (DRA) and clinical antimicrobial activity in vivo in the plaque glycolysis and regrowth method (PGRM). METHODS: Formulations compared in this testing included commercially available CPC mouthrinses: Crest Pro Health (CPH), (containing 700 ppm formulated CPC); Colgate Total Puerto Rico (CT450), (containing 450 ppm formulated CPC); Colgate Total US (CT750), (containing 750 ppm formulated CPC); and Scope Mouthwash (SCP), (containing 450 ppm formulated CPC). A water control (CTR) was included in one of the PGRM clinical trials. Two separate clinical PGRM studies employed a controlled, double-blind, randomized, crossover design where qualified adult PGRM panelists were supplied with acclimation NaF dentifrice for use throughout the trials. On treatment days, subjects sampled baseline plaque and then rinsed with assigned mouthrinse following morning toothbrushing. Treated plaque samples were collected 15 and 45 minutes after rinsing. Sampled plaques were vortexed, normalized for biomass and incubated under standard conditions to assess glycolysis. pH response of treated plaques in incubation buffers were compared to baseline untreated plaque values and an Area Under Curve (AUC) composite/aggregate analysis of glycolysis inhibition was used for treatment comparisons. A laboratory disk retention substantivity/bioavailability assay measured adsorption affinity of CPC in mouthrinse for anionic cellulose disks in vitro. RESULTS: Clinical PGRM studies showed significant differences in antibacterial clinical efficacy of commercialized mouthrinses. Combining clinical study results reveals rank ordered efficacy CPH > CT750 > SCP > CT450 > CTR. Comparison of DRA to PGRM glycolysis showed a linear relation highlighting correlation of CPC bioavailability to clinical antimicrobial performance of CPC mouthrinses.

A six-week clinical evaluation of the plaque and gingivitis efficacy of an oscillating-rotating power toothbrush with a novel brush head utilizing angled CrissCross bristles versus a sonic toothbrush.

OBJECTIVE: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Triumph with SmartGuide with Oral-B CrossAction brush head) versus a sonic toothbrush (Sonicare DiamondClean) for plaque and gingivitis reduction over a six-week period. METHODS: This was a single-center, randomized, examiner-blind, two-treatment, parallel group study involving 65 subjects per group. Subjects presenting with mild-to-moderate gingivitis at Baseline were randomly assigned to either the oscillating-rotating brush or the sonic brush. They were instructed to use their assigned toothbrush and a standard fluoride dentifrice for two minutes twice daily at home for six weeks. Gingivitis and plaque were assessed at Baseline and Week 6 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA), with baseline as the covariate. Subjects also completed a consumer perception questionnaire to evaluate their brushing experience. RESULTS: One-hundred and thirty subjects were enrolled in the study and randomized to treatment. Sixty-four subjects per group completed the trial. Both brushes produced statistically significant reductions in gingivitis and plaque measures at Week 6 relative to Baseline (p < 0.001 for all). The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in all gingivitis and plaque measures compared to the sonic toothbrush. The benefits for the oscillating-rotating brush over the sonic brush were 32.6% for gingivitis, 35.4% for gingival bleeding, 32% for number of bleeding sites, 22% for whole mouth plaque, 24.2% for gingival margin plaque, and 33.3% for approximal plaque (p < or = 0.001 for all measures except gingival margin plaque, where p = 0.018). Analysis of the consumer perception questionnaire results showed subjects using the oscillating-rotating brush rated it higher for overall use experience and key attributes related to cleaning, gentleness, and brush head shape/size versus subjects in the sonic brush group. There were no adverse events reported or observed for either brush. CONCLUSION: This six-week randomized, examiner-blind, comparative clinical study showed the oscillating-rotating toothbrush, with a novel brush head incorporating angled CrissCross bristles, was significantly better than an advanced sonic power toothbrush at reducing gingival inflammation and bleeding, as well as reducing whole mouth plaque, plaque along the gumline, and in the approximal regions.

Plaque removal efficacy of oscillating-rotating power toothbrushes: review of six comparative clinical trials.

PURPOSE: This review of six clinical trials provides a comprehensive overview of the results of statistical analyses to explore between-brush differences, specifically in the lingual, gingival marginal, and approximal ("hard-to-clean") areas, in post-brushing plaque removal of oscillating-rotating (O-R) power toothbrushes compared to either a marketed sonic power toothbrush or a manual toothbrush control. METHODS: All studies were single-center, randomized and controlled, and examiner-blind. Four trials were four-period crossover design with replicate single-use brushing, while two studies were parallel group investigations (4 or 12 weeks) with multiple brushings and assessments at each visit. Generally healthy subjects were enrolled. Plaque evaluations were via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) or the Rustogi Modification of the Navy Plaque Index (RMNPI). At each evaluation visit, subjects brushed with either the randomly assigned O-R power brush [Oral-B Professional Care Series 4000 (Triumph) or Oral-B Vitality with Floss Action or Precision Clean brush head] or a control brush [Sonicare FlexCare with ProResults brush head (three trials) or an American Dental Association (ADA) reference manual toothbrush (three trials)]. ANCOVA and ANOVA analyses subsequently evaluated specifically the 'hard-to-clean' tooth surfaces for between-brush differences. RESULTS: In total, 462 subjects completed the trials and were evaluable. While all toothbrushes provided significant post-brushing versus baseline plaque removal efficacy, the magnitude of the reduction was consistently superior for the O-R brush compared to either the sonic power or manual brush control in all the 'hard-to-clean" region-specific analyses. Adjusted mean RMNPI or TMQHPI benefits favoring the O-R brush relative to the sonic brush control were collectively 18% to 34% greater on lingual surfaces (P < or = 0.044), 32% to 49% greater on lingual approximal surfaces (P < 0.001), and 32% and 31% greater in lingual mandibular and lingual mandibular anterior regions, respectively (P < or = 0.005). Post-brushing whole mouth adjusted mean reduction RMNPI or TMQHPI benefits favoring the O-R brush compared to the manual brush control were collectively 31% to 206% greater on lingual surfaces (P < or = 0.001), 29% to 217% greater on lingual approximal surfaces (P < or = 0.001), and 67% to 526% greater in lingual gingival margin regions, respectively (P < or = 0.001). All study toothbrushes were well-tolerated.

Depth profile analysis of non-specific fluorescence and color of tooth tissues after peroxide bleaching.

PURPOSE: To examine laboratory changes of endogenous non-specific fluorescence and color throughout subsurface of tooth structures prior to and following peroxide bleaching. METHODS: Extracted human teeth were cross sectioned and mounted on glass slides. Cross sections were examined for internal color (digital camera) and nonspecific fluorescence (microRaman spectroscopy) throughout the tooth structure at specified locations. Surfaces of sections were then saturation bleached for 70 hours with a gel containing 6% hydrogen peroxide. Cross sections were reexamined for color and non-specific fluorescence changes. RESULTS: Unbleached enamel, dentin-enamel junction and dentin exhibit different CIELab color and non-specific fluorescence properties. Bleaching of teeth produced significant changes in color of internal cross sections and substantial reductions of non-specific fluorescence levels within enamel dentin and DEJ. Enamel and dentin non-specific fluorescence were reduced to common values with bleaching with enamel and the DEJ showing larger reductions than dentin.

Efficacy of 3 toothbrush treatments on plaque removal in orthodontic patients assessed with digital plaque imaging: a randomized controlled trial.

INTRODUCTION: Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects. METHODS: This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating electric toothbrush with a specially designed orthodontic brush head (Oral-B Triumph, OD17; Procter & Gamble, Cincinnati, Ohio); (2) the same electric toothbrush handle with a regular brush head (EB25; Procter & Gamble); and (3) a regular manual toothbrush (American Dental Association, Chicago, Ill). The primary outcome was the plaque score change from baseline, which we determined using digital plaque image analysis. RESULTS: Forty-five subjects completed the study. The differences in mean plaque removal (95% confidence interval) between the electric toothbrush with an orthodontic brush head (6% [4.4%-7.6%]) or a regular brush head (3.8% [2.2%-5.3%]) and the manual toothbrush were significant (P <0.001). Plaque removal with the electric toothbrush with the orthodontic brush head was superior (2.2%; P = 0.007) to the regular brush head. No adverse events were seen. CONCLUSIONS: The electric toothbrush, with either brush head, demonstrated significantly greater plaque removal over the manual brush. The orthodontic brush head was superior to the regular head.

A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

OBJECTIVE: The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. METHODS: This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. RESULTS: Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque (38% and 24% at Weeks 4 and 12, respectively; p < 0.001), gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p < 0.001). Both power toothbrushes were well-tolerated. CONCLUSION: An advanced oscillating-rotating power toothbrush produced substantial, statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

A single-brushing study to compare plaque removal efficacy of a new power brush to an ADA reference manual toothbrush.

PURPOSE: To determine the effectiveness of a new multi-directional power toothbrush in reducing plaque when compared to a standard manual toothbrush control in a single brushing design. METHODS: This was a randomized, replicate use, single-brushing, two-treatment, four-period, examiner-blinded crossover clinical trial at a single center. Qualified subjects entered an acclimation phase, after which they were randomly assigned to one of four treatment sequences specifying the order of use of the two test toothbrushes: a novel multi-directional power toothbrush with a 2-D drive (Oral-B Vitality TriZone) and an American Dental Association (ADA) reference soft manual brush. Subjects used each brush twice over the course of the trial. At each of the four period visits, after abstaining from oral hygiene for 24 hours, participants received a baseline (pre-brushing) Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) examination. They then brushed under supervision with the brush assigned for that period for 2 minutes (multi-directional power brush) or as customary (manual brush control). Subjects were then re-examined for TMQHPI post-brushing to determine the plaque removal efficacy of the respective brushes. A washout phase of 2-5 days separated treatment periods. TMQHPI scores were averaged on a per-subject basis, and analyzed using a mixed model analysis of covariance for a crossover design. RESULTS: All 36 randomized subjects completed the study and were fully evaluable. Both the multi-directional power and manual control brushes produced statistically significant mean whole mouth TMQHPI plaque reductions compared to baseline (P < 0.001). Comparing the brushes, the power brush provided a 7.9% significantly superior mean whole mouth plaque reduction relative to the manual brush control (P= 0.003). Both toothbrushes were well-tolerated.

A novel power toothbrush with multi-directional, triple zone cleaning technology.

PURPOSE: Numerous laboratory and clinical studies have proven that certain power toothbrush technologies are more effective in removal of dental plaque and reduction of gingivitis than regular manual toothbrushes. Regardless of this evidence, there is still a large group of individuals who prefer the experience of a manual-like toothbrush. Recently a novel multi-directional power brush has been developed as an alternative for those people who favor the traditional size and shape of a manual toothbrush and prefer the manual brushing technique, but would benefit from the greater cleaning efficiency of the power brush. METHODS: This unique multi-directional power toothbrush with triple-zone cleaning technology has been tested in multiple clinical trials. This special issue introduces the technical features of the brush and presents four clinical investigations conducted with this power toothbrush versus manual and sonic controls. RESULTS: The studies described in this issue demonstrate the superior efficacy of the multi-directional brush in plaque and gingivitis reduction relative to control brushes, even in the hard-to-reach interdental spaces and marginal areas.