A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial.

BACKGROUND: The dissolution of dental calculus, safely and at home, is among the more challenging issues facing the over-the-counter healthcare industry. Pontis Biologics, Inc. has developed novel model of calculus development and structure and has formulated a dentifrice (Tartarase™) using digestive enzymes as active ingredients that is shown to dissolve dental calculus in this Proof of Principle clinical trial. METHODS: This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4 weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30 min then brushed again with Tartarase, once daily). RESULTS: The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4 weeks of unsupervised at home use of the Tartarase toothpaste formulation. CONCLUSIONS: This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide. TRIAL REGISTRATION: This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.

Efficacy of water flossing on clinical parameters of inflammation and plaque: A four-week randomized controlled trial.

Purpose The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque.Methods One hundred and five participants were enrolled in this single-blind, single-center, parallel, four-week, IRB/IEC-approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2-weeks, and 4-weeks.Results All participants completed the study (n=105). All groups showed a statistically significant reduction for BOP, MGI, and RMNPI at 4-weeks (p<0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30, and 0.20, respectively) and RMNPI (0.13, 0.11, and 0.06, respectively) (p<0.05 for all comparisons). No adverse events were reported.Conclusion This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over four weeks.

Efficacy of water flossing on clinical parameters of inflammation and plaque: A 4-week randomized controlled trial.

BACKGROUND: The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque. METHODS: One hundred and five participants were enrolled in this single-blind, single-centre, parallel, 4-week, IRB/IEC-approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI) and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2 and 4 weeks. RESULTS: All participants completed the study (n = 105). All groups showed a statistically significant reduction for BOP, MGI and RMNPI at 4 weeks (p < 0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30 and 0.20, respectively) and RMNPI (0.13, 0.11 and 0.06, respectively; p < 0.05 for all comparisons). No adverse events were reported. CONCLUSION: This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over 4 weeks.

Effectiveness of a sonic-flosser toothbrush with different size brush heads and manual toothbrush plus dental floss on plaque, gingival bleeding and inflammation in adults with naturally occurring gingivitis: A 4-week randomized controlled trial.

OBJECTIVE: To compare the effectiveness of three oral hygiene groups: a novel sonic-flosser toothbrush with a compact brush head, a novel sonic-flosser toothbrush with a full size brush head and manual toothbrush plus dental floss on the reduction of gingival bleeding after 4 weeks. Secondarily, the groups were compared on the reduction of gingival inflammation and dental plaque. MATERIALS AND METHODS: One hundred and five (n = 105) healthy adults were enrolled in this randomized, examiner-blind, three-group, parallel clinical trial. Subjects were assigned to one of three groups: sonic-flosser toothbrush with full size brush head (SFF), sonic-flosser toothbrush with compact brush head (SFC), or manual toothbrush and string floss (MTF). Bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification of the Navy Plaque Index (RMNPI) scores were recorded at baseline, 2-weeks, and 4-weeks. RESULTS: All subjects completed the study. All three groups demonstrated a significant reduction in BOP, MGI and RMNPI from baseline to 4-weeks for all areas recorded (p < 0.001), except gingival margin plaque scores for SFF, SFC and MTF (p = 0.203, p = 0.082, p = 0.324 respectively). Both the SFF and SFC groups were statistically more effective than MTF for whole mouth BOP, MGI and RMNPI (p < 0.001) and proximal areas (p = 0.022 or less). There were no adverse events reported by the subjects or identified by the examiner during the study. CONCLUSION: The sonic-flosser toothbrush with a full size or compact brush head was statistically and clinically more effective at improving gingival health and reducing plaque than manual toothbrush and dental floss for adults with naturally occurring gingivitis over 4-weeks.

Efficacy of the Use of a Water Flosser in Addition to an Electric Toothbrush on Clinical Signs of Inflammation: 4-Week Randomized Controlled Trial.

This study compared the use of an oscillating-rotating powered toothbrush and a water flosser to the use of an oscillating-rotating powered toothbrush on the reduction of clinical signs of inflammation and plaque. METHODS: Seventy adult participants (N = 70) completed this examiner-blind, two-group, parallel clinical trial. The participants were randomized into either the water flosser + oscillating-rotating powered toothbrush (WF) group or the oscillating-rotating powered toothbrush only group (OR). Inflammation was measured by bleeding on probing (BOP) and modified gingival index (MGI) at baseline, 2 weeks, and 4 weeks. Plaque was scored using Rustogi Modification of the Navy Plaque Index (RMNPI) at the same timepoints. Data was reported for whole mouth, areas (marginal and proximal), and surfaces (facial and lingual). A post-study Likert scale questionnaire was completed at the 4-week visit. RESULTS: Both groups demonstrated significant reductions in BOP, MGI, and RMNPI from baseline to 4 weeks for whole mouth (P < .001). The WF group was 37% more effective at reducing BOP, 36% for MGI, and 33% for RMNPI than the OR group at 4 weeks for whole mouth (P < .001; except RMNPI P = .003). Additionally, the WF group was significantly more effective at reducing proximal BOP (37%, P < .001), MGI (46%, P < .001), and RMNPI (52%, P = .004) compared to OR at 4 weeks. The questionnaire revealed subjects in both groups felt the device was easy to use, the instructions were clear, and their mouth felt fresh and clean. There were no adverse events reported during the study. CONCLUSION: An oral hygiene regimen consisting of the use of a water flosser in addition to an oscillating-rotating powered toothbrush significantly improved gingival health. The products used in both groups were effective and well-tolerated by the study population.

Vacuum Casting and Mechanical Characterization of Nanocomposites from Epoxy and Oxidized Multi-Walled Carbon Nanotubes.

Sample preparation is an important step when testing the mechanical properties of materials. Especially, when carbon nanotubes (CNT) are added to epoxy resin, the increase in viscosity complicates the casting of testing specimens. We present a vacuum casting approach for different geometries in order to produce specimens from functional nanocomposites that consist of epoxy matrix and oxidized multi-walled carbon nanotubes (MWCNTs). The nanocomposites were characterized with various mechanical tests that showed improved fracture toughness, bending and tensile properties performance by addition of oxidized MWCNTs. Strengthening mechanisms were analyzed by SEM images of fracture surfaces and in-situ imaging by digital image correlation (DIC).

Evaluation of the Addition of a Water Flosser to Manual Brushing on Gingival Health.

OBJECTIVES: The purpose of this clinical trial was to compare the use of a manual toothbrush plus water flosser to a manual toothbrush alone on clinical signs of inflammation. METHODS: Seventy-two subjects were randomized into two groups and completed this four-week, single-blind, parallel, clinical trial. Group 1 used a Waterpik®Water Flosser (WF) once daily and brushed with a manual toothbrush twice a day. Group 2 brushed twice a day with a manual toothbrush only (MT). Subjects in group 1 were provided written and verbal instructions for the water flosser and all participants used the toothpaste and manual brush provided, brushing as they normally do. Data were evaluated at baseline (BSL), two weeks (W2), and four weeks (W4) for bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification of the Navy Plaque Index (RMNPI). RESULTS: Both groups showed a significant reduction from BSL for BOP, MGI, and RMNPI at W2 and W4, except for MT W2 facial proximal MGI (p = 0.153) and marginal RMNPI (p = 0.324). The WF was significantly more effective than the MT for reducing BOP, MGI, and RMNPI at W2 and W4 for all areas measured. The WF was 3.13 times as effective for reducing BOP, 2.69 times for MGI, and 2.44 times for RMNPI at W4 (p < 0.001) for whole mouth scores. CONCLUSIONS: The addition of the Waterpik®Water Flosser to manual tooth brushing is significantly more effective for improving gingival health than manual tooth brushing alone.

Comparison of Water Flosser and Interdental Brush on Reduction of Gingival Bleeding and Plaque: A Randomized Controlled Pilot Study.

OBJECTIVES: The purpose of this randomized, two-week, single blind, two-group parallel pilot study was to compare the reduction in gingival bleeding and plaque in subjects using a water flosser or interdental brush, each combined with a manual toothbrush. METHODS: Twenty-eight subjects completed the study. Subjects were randomly assigned to one of two groups: Waterpik® Water Flosser (WF) plus manual toothbrush or interdental brushes (IDBs) plus a manual toothbrush. Bleeding on probing (BOP) was measured at six sites and reported for whole mouth, lingual, facial, and interproximal areas. Plaque data were measured using the Rustogi Modification of the Navy Plaque Index (RMNPI) and were reported for whole mouth, approximal, marginal, facial, and lingual areas. Subjects received verbal and written instructions on the use of their interdental product and demonstrated proficiency prior to starting the study. RESULTS: There were no differences between the groups for BOP or RMNPI at baseline. Both groups demonstrated a significant reduction in BOP and RMNPI for all regions and areas measured from baseline to two weeks. The WF was more effective than the IDBs for BOP whole mouth (56%), facial (44%), approximal whole mouth (53%), and approximal facial (41%). Post hoc power analysis showed that the sample size was not adequate to detect a significant difference between groups for lingual and marginal assessments for BOP or any area for RMNPI. CONCLUSIONS: The Waterpik Water Flosser is more effective than IDBs for reducing gingival bleeding over two weeks.

Comparison of Water Flosser and Interdental Brush on Plaque Removal: A Single-Use Pilot Study.

OBJECTIVES: The purpose of this randomized, single-use, single-blind, two-group, parallel pilot study was to compare the plaque removal ability of a water flosser and interdental brush when used in combination with a manual toothbrush. METHODS: Twenty-eight (28) subjects completed the study. Subjects were randomly assigned to one of two groups: Waterpik®Water Flosser (WF) plus manual tooth brushing or interdental brushes (IDB) plus manual tooth brushing. Pre-cleaning plaque scores were obtained using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects were instructed on the use of their interdental product. Post-cleaning scores were obtained after a supervised brushing and use of the interdental device. Scores were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject. RESULTS: There were no differences between the groups for pre-cleaning plaque scores for whole mouth, marginal, approximal, facial, or lingual regions. Both groups showed significant reductions in plaque from baseline for all areas measured (p < 0.001). The WF group was significantly more effective than the IDB group for removing plaque from all areas measured. Specifically, the WF was 18% more effective for whole mouth and marginal areas, 20% for approximal areas, 11% for facial areas, and 29% for lingual areas. CONCLUSIONS: The Waterpik Water Flosser and manual toothbrush removes significantly more plaque from tooth surfaces (whole mouth, marginal, approximal, facial, and lingual) than interdental brushes and a manual toothbrush after a single use.

Efficacy of Two Interdental Cleaning Devices on Clinical Signs of Inflammation: A Four-Week Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to compare the reduction of the clinical signs of inflammation by two power interdental cleaning devices combined with a manual toothbrush. METHODS: Sixty-nine subjects completed this randomized, four-week, single-blind, two-group, parallel clinical study. Subjects were randomly assigned to one of two treatment groups: Waterpik Water Flosser (WF) plus a manual toothbrush; or Sonicare Air Floss Pro (AFP) plus a manual toothbrush. All subjects received both written and verbal instructions and demonstrated proficiency prior to starting the study. Instructions were reviewed at the two-week visit (W2). Data were evaluated for whole mouth, lingual, and facial areas for bleeding on probing (BOP) and Modified Gingival Index (MGI). Plaque data were recorded for whole mouth, lingual, facial, approximal, and marginal areas of the tooth using the Rustogi Modification of the Navy Plaque Index (RMNPI). BOP, MGI, and RMNPI were scored at baseline (BSL), two weeks, and four weeks (W4). RESULTS: Both groups showed significant reductions in BOP and MGI from baseline for all regions and time points measured (p < 0.001). Both groups showed significant reductions from baseline for all areas at W4 for RMNPI (p < 0.001). The WF group was significantly more effective than the AFP group at reducing bleeding and gingivitis for all areas measured at all time points. At W4, the WF group was 54% more effective for bleeding and 32% for gingivitis (p < 0.001). Plaque accumulation was significantly less at W4 for the WF group compared to the AFP group (28%, p 0.017). CONCLUSIONS: The Waterpik Water Flosser is significantly more effective than the Sonicare Air Floss Pro for reducing clinical signs of inflammation.

Evaluation of the plaque removal efficacy of a water flosser compared to string floss in adults after a single use.

OBJECTIVE: To compare the plaque removal efficacy of a water flosser to string floss combined with a manual toothbrush after a single use. METHODS: Seventy adult subjects participated in this randomized, single-use, single-blind, parallel clinical study. Subjects were assigned to one of two groups; Waterpik Water Flosser plus a manual toothbrush (WF) or waxed string floss plus a manual toothbrush (SF). Each participant brushed for two minutes using the Bass technique. The WF group added 500 ml of warm water to the reservoir and followed the manufacturer's instructions, and the SF group used waxed string floss between each tooth, cleaning the mesial and distal surfaces as instructed. Subjects were observed to ensure they covered all areas and followed instructions. Scores were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject using the Rustogi Modification of the Navy Plaque Index. RESULTS: The WF group had a 74.4% reduction in whole mouth plaque and 81.6% for approximal plaque compared to 57.7% and 63.4% for the SF group, respectively (p < 0.001). The differences between the groups showed the water flosser was 29% more effective than string floss for overall plaque removal and approximal surfaces specifically (p < 0.001). The WF group was more effective in removing plaque from the marginal, lingual, and facial regions; 33%, 39%, and 24%, respectively (p < 0.001). CONCLUSION: The Waterpik Water Flosser and manual toothbrush is significantly more effective than a manual brush and string floss in removing plaque from tooth surfaces.

The addition of a water flosser to power tooth brushing: effect on bleeding, gingivitis, and plaque.

OBJECTIVE: The primary objective of this study was to compare the effectiveness of a water flosser plus sonic toothbrush to a sonic toothbrush alone on the reduction of bleeding, gingivitis, and plaque. The secondary objective was to compare the effectiveness of different sonic toothbrushes on bleeding, gingivitis, and plaque. METHODS: One-hundred and thirty-nine subjects completed this randomized, four-week, single-masked, parallel clinical study. Subjects were assigned to one of four groups: Waterpik Complete Care, which is a combination of a water flosser plus power toothbrush (WFS); Sensonic Professional Plus Toothbrush (SPP); Sonicare FlexCare toothbrush (SF); or an Oral-B Indicator manual toothbrush (MT). Subjects were provided written and verbal instructions for all power products at baseline, and instructions were reviewed at the two-week visit. Data were evaluated for whole mouth, facial, and lingual surfaces for bleeding on probing (BOP) and gingivitis (MGI). Plaque data were evaluated for whole mouth, lingual, facial, approximal, and marginal areas of the tooth using the Rustogi Modification of the Navy Plaque Index (RMNPI). Data were recorded at baseline (BL), two weeks (W2), and four weeks (W4). RESULTS: All groups showed a significant reduction from BL in BOP, MGI, and RMNPI for all areas measured at the W2 and W4 visits (p < 0.001). The reduction of BOP was significantly higher for the WFS group than the other three groups at W2 and W4 for all areas measured (p < 0.001 for all, except p = 0.007 at W2 and p = 0.008 for W4 lingual comparison to SPP). The WFS group was 34% more effective than the SPP group, 70% more effective than the SF group, and 1.59 times more effective than the MT group for whole mouth bleeding scores (p < 0.001) at W4. The reduction of MGI was significantly higher for the WFS group; 23% more effective than SPP, 48% more effective than SF, and 1.35 times more effective than MT for whole mouth (p <0.001) at W4. The reduction of MGI was significantly higher for WFS than the SF and MT for facial and lingual surfaces, and more effective than the SPP for facial surfaces (p < 0.001) at W4. The WFS group showed significantly better reductions for plaque than the SF and MT groups for whole mouth, facial, lingual, approximal, and marginal areas at W4 (p < 0.001; SF facial p = 0.025). For plaque reduction, the WFS was significantly better than the SPP for whole mouth (p = 0.003) and comparable for all other areas and surfaces at W4. The WFS was 52% more effective for whole mouth, 31% for facial, 77% for lingual, 1.22 times for approximal, and 1.67 times for marginal areas compared to the SF for reducing plaque scores at W4 (p < 0.001; SF facial p = 0.025). The SPP had significantly higher reductions than the SF for whole mouth and lingual BOP and MGI scores, and whole mouth, approximal, marginal, and lingual areas for plaque at W4. CONCLUSION: The Waterpik Complete Care is significantly more effective than the Sonicare FlexCare toothbrush for reducing gingival bleeding, gingivitis, and plaque. The Sensonic Professional Plus Toothbrush is significantly more effective than the Sonicare Flex-Care for reducing gingival bleeding, gingivitis, and plaque.

Comparison of two power interdental cleaning devices on plaque removal.

OBJECTIVE: The objective of this randomized, single-use, single-blind, two-group, parallel clinical trial was to evaluate the supragingival plaque removal efficacy of two power interdental devices combined with a manual toothbrush. METHODS: Eighty-two (82) subjects completed the study. Subjects were randomly assigned to one of two groups: Waterpik Water Flosser (WF) plus manual tooth brushing or Sonicare Air Floss (AF) plus manual tooth brushing. Pre-brushing and interdental cleaning scores were obtained using the Rustogi Modified Navy Plaque Index (RMNPI). Subjects were instructed on the use of the manual toothbrush and assigned an interdental product. Post-brushing and interdental cleaning scores were obtained after a supervised two-minute brushing and use of the interdental device. Scores were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject. RESULTS: There were no differences in the pre-cleaning plaque scores for whole mouth, marginal, approximal, facial, or lingual regions. Both groups showed significant reductions in plaque from baseline for all regions. The WF group demonstrated significantly higher reductions as measured by the RMNPI compared to the AF for whole mouth (74.9% vs. 57.5%), marginal (58.6% vs. 36.7%), approximal (92.1% vs. 77.4%), facial (83.6% vs. 69.1%), and lingual (65.7% vs. 45.4%). CONCLUSION: The use of the Waterpik Water Flosser removes significantly more plaque from tooth surfaces (whole mouth, marginal, approximal, facial, and lingual) than the Sonicare Air Floss when used with a manual toothbrush.

Comparison of two power interdental cleaning devices on the reduction of gingivitis.

OBJECTIVE: The objective of this study was to compare the reduction of gingivitis by two power interdental devices combined with a manual toothbrush. METHODS: Eighty-two subjects completed this randomized, four-week, single-blind, two-group parallel clinical study. Subjects were randomly assigned to one of two groups: Waterpik Water Flosser (WF) plus manual tooth brushing or Sonicare Air Floss (AF) plus manual tooth brushing. Subjects were provided written and verbal instructions for all products at the baseline visit and instructions were reviewed at the two-week (W2) visit. Data were evaluated for whole mouth, lingual, and facial areas for gingivitis and bleeding on probing. Plaque data were evaluated for whole mouth, lingual, facial, approximal, and marginal areas of the tooth. Gingivitis, bleeding on probing, and plaque were scored at baseline (BSL), two weeks, and four weeks (W4). RESULTS: Both groups showed significant reductions in gingivitis, bleeding on probing, and plaque from baseline for all regions and time points measured (p < 0.001). The WF group was significantly more effective than the AF group at reducing plaque and gingivitis at W2 and W4 for all areas measured (p <0.001). At W4, the WF group was 80% more effective than AF for whole mouth gingivitis reduction, and twice as effective for the lingual region. In terms of plaque removal at W4, the WF group was 70% more effective for whole mouth (50.9% vs. 30%), 60% for approximal area (76.7% vs. 48%), and 47% for facial (52.8% vs. 35.9%) surfaces. The WF was twice as effective for lingual areas and more than three times as effective for marginal areas vs. the AF group (p <0.001). Results for bleeding on probing showed the WF group was numerically better than the AF group for all areas and time points, with these improvements being statistically significance for whole mouth (p = 0.02) and facial area (p = 0.004) at W2, and for the facial area (p = 0.02) at W4. CONCLUSION: The Waterpik Water Flosser is significantly more effective than Sonicare Air Floss for reducing gingivitis and plaque.

Effect of a dental water jet with orthodontic tip on plaque and bleeding in adolescent patients with fixed orthodontic appliances.

INTRODUCTION: Effective self-care is difficult for people with orthodontic appliances because of the inherent design of brackets and archwires. It is not uncommon to have increases in plaque and gingivitis after placement of fixed appliances. The purpose of this study was to evaluate the effect of using a dental water jet (DWJ) with a specialized tip (orthodontic) on plaque and bleeding in adolescent orthodontic patients with fixed appliances. METHODS: One hundred six subjects were enrolled in this single blind, parallel clinical study. They were randomly assigned to 1 of 3 treatment groups: group 1, once daily irrigation with a DWJ and orthodontic jet tip plus a manual toothbrush; group 2, once daily flossing (FL) plus a manual toothbrush; group 3, manual toothbrush (MT) only. Plaque index (PI) and bleeding index (BI) scores were recorded at baseline, and at 2 and 4 weeks. RESULTS: All groups showed statistically significant reductions in PI (whole mouth and interproximal) at 2 and 4 weeks (P <.001). In group 1, the DWJ was statistically more effective at reducing whole-mouth and interproximal plaque than the methods in the other groups (P >.001) at both 2 and 4 weeks, whereas the FL protocol in group 2 was significantly more effective than the MT protocol in group 3 at 4 weeks (P =.025) for whole-mouth plaque and at 2 and 4 weeks (P = .011 and P = .028, respectively) for interproximal plaque. All groups showed statistically significant reductions in BI (whole mouth and interproximal) at 2 and 4 weeks (P <.001). The DWJ in group 1 was statistically more effective at reducing whole-mouth bleeding than the protocols of the other groups at 2 and 4 weeks (P <.001), and the FL was statistically more effective than the MT at both times (P <.001). Both the DWJ and the FL were significantly more effective than the MT at 2 weeks (P <.001 and P <.016, respectively) for interproximal bleeding, but there were no differences between the groups at 4 weeks. CONCLUSIONS: A DWJ with a specialized orthodontic jet tip is effective for adolescents in fixed orthodontic appliances; it demonstrated beneficial results for the reduction of plaque and bleeding.

Assessment of pharmacokinetics and pharmacodynamic effects related to abuse potential of a unique oral osmotic-controlled extended-release methylphenidate formulation in humans.

This was a double-blind, placebo-controlled, randomized, 5-period crossover study in 49 healthy subjects with a history of light (occasional) recreational stimulant use, to evaluate the abuse-related subjective effects of oral osmotic-controlled extended-release methylphenidate with comparable doses of immediate-release methylphenidate. Healthy subjects with a history of light recreational stimulant use were enrolled in the study if they demonstrated a positive response to a 20-mg dose of d-amphetamine and a negative placebo response. Enrolled subjects received single doses of placebo, 54 and 108 mg osmotic-controlled extended-release methylphenidate, and 50 and 90 mg immediate-release methylphenidate. For each treatment, pharmacokinetics, pharmacodynamics, and safety were assessed for 24 hours. Subjective data were collected through standard questionnaires and visual analog scales for positive, stimulant, negative, and other effects. Immediate-release and osmotic-controlled extended-release methylphenidate produced expected plasma concentration-time profiles of d-methylphenidate. Both doses of immediate-release methylphenidate (50 and 90 mg) produced statistically significantly higher subjective effects (eg, positive, stimulant) with respect to placebo for all measures. The higher osmotic-controlled extended-release methylphenidate dose of 108 mg also produced statistically significant differences from placebo for most measures. However, the most commonly prescribed therapeutic dose of osmotic-controlled extended-release methylphenidate (54 mg) did not produce significant differences from placebo for most measures. In addition, for comparable dose levels, osmotic-controlled extended-release methylphenidate produced lower positive and stimulant subjective effects than immediate-release methylphenidate, and low-dose immediate-release methylphenidate (50 mg) produced greater subjective effects than high-dose osmotic-controlled extended-release methylphenidate, with many effects demonstrating statistically significant differences. These data support the hypothesis that a formulation can modulate abuse potential by controlling the rate and extent of drug delivery.

Do formulation differences alter abuse liability of methylphenidate? A placebo-controlled, randomized, double-blind, crossover study in recreational drug users.

The primary objective of this study was to determine if the abuse liability of methylphenidate is governed by formulation differences that affect rates of drug delivery. In this double-blind, placebo-controlled, randomized, crossover study, subjects with a history of recreational drug use received single oral doses of placebo, 60 mg of immediate-release methylphenidate (IR) and 108 mg of extended-release methylphenidate (osmotic release oral system [OROS]). Over 24 hours after dosing, blood was collected to determine plasma concentrations of methylphenidate, and subjects completed subjective assessments of abuse liability (Addiction Research Center Inventory, Drug Rating Questionnaire-Subject, and Subjective Drug Value). The abuse-related subjective effects of IR and OROS methylphenidate were statistically significantly different from placebo, confirming the overall validity of the study. Although a higher dose of OROS methylphenidate was used compared with IR methylphenidate (108 mg vs 60 mg), subjective effects were consistently lower for OROS compared with IR methylphenidate (statistically significant for 3 of 6 measures of positive effects), particularly at early time points. In general, pharmacokinetic-pharmacodynamic parameters were correlated from a poor to modest degree, with greater correlations observed for IR methylphenidate. In addition, a post hoc "qualification" method was developed, which demonstrated that pharmacological qualification might improve the assessment of subjective effects. Although requiring epidemiological confirmation, the results suggest that OROS methylphenidate, with its characteristic slow ascending plasma concentration profile, may have lower abuse potential. This conclusion is reflected by lower subjective responses during early hours as compared with the IR formulation with its rapid drug delivery and accompanying greater subjective effects.

Research priorities in augmentative and alternative communication as identified by people who use AAC and their facilitators.

Two focus groups comprised of adults who used AAC and two focus groups comprised of adult AAC facilitators in Ontario, Canada were asked to identify their own AAC research priorities and to state their levels of agreement with previously identified research priorities in AAC. Members of the focus group who used AAC had physical disabilities since birth except one participant who became disabled at age 2 years. Using focus group methodology and analysis, the participants were asked to generate their own AAC research priorities. A questionnaire and Likert-type scale was used to determine their levels of agreement with six research priorities set a decade earlier by a group of AAC researchers sponsored by the United States-based National Institute of Deafness and other Communication Disorders (NIDCD). Focus group members stressed the importance of (a) preparing people who use AAC to succeed in situations such as maintaining friendships, dating, and finding jobs; (b) improving service delivery of their AAC devices; (c) improving technology in high tech and low tech devices; (d) increasing public awareness of people who use AAC; (e) improving methods of teaching reading skills to people who use AAC; and (f) improving AAC communications training for all healthcare professionals.

Relative abuse potential of opioid formulations in Canada: a structured field study.

INTRODUCTION: While prescription opioids can improve quality of life through pain relief they are susceptible to misuse. This field study characterizes the relative susceptibility and attractiveness of a new analgesic patch, with fentanyl embedded in a matrix material, compared to other opioid dose formulations. METHODS: Recreational opioid abusers (N = 42; 31 male, 1 female)from three Canadian sites participated in structured interviews. They were presented with nine products, some of which were hypothetical (fentanyl [F], hydromorphone [H], and oxycodone [O] in each of three formulations: matrix patch [M], reservoir-type gel patch [G], and tablet [T]). The attractiveness and tampering potential of each product was ranked using two 7-point Likert scales (Value of Product and Likelihood to Tamper), an index representing the product of the two scales, a 17-item Opiate Attractiveness Scale (OAS), relative street value, and rank order of overall desirability. Non-parametric analyses were used to compare each product to the FM. RESULTS: The FT, HT, and FM were highly valued and most likely to be tampered with. The products were ranked in decreasing order of desirability as follows: FT > HT > FM > FG > OT > HM > HG > OM > OG. On the OAS, FM was more attractive than all gel-patch products (p < 0.001), and OT was most attractive overall. FM was statistically similar to OT, FT, OM, and HT. Of the 42 subjects, 25 (60 percent) preferred the matrix patch to the gel patch. Of the 17 subjects who preferred the gel patch, 10 (59 percent) were from a region generally unfamiliar with that formulation. CONCLUSIONS: Fentanyl is attractive to opioid abusers regardless of formulation. In Canada, a fentanyl matrix patch may be at higher risk for diversion, tampering, and abuse than other transdermal opioid formulations. These findings should be confirmed by epidemiological studies. Comparative risk management programs should be part of the development of any new narcotic delivery system.

Efficacy of celecoxib, a COX-2-specific inhibitor, and naproxen in the management of acute ankle sprain: results of a double-blind, randomized controlled trial.

OBJECTIVE: To assess the efficacy and safety of celecoxib and naproxen in the treatment of acute ankle sprain. DESIGN: Double-blind, parallel-group, randomized trial. SETTING: Multicenter outpatient. PATIENTS: Adult patients (n = 397) with acute first-degree or second-degree ankle sprain. INTERVENTIONS: Patients randomized to celecoxib 200 mg b.i.d. (n = 198) or naproxen 500 mg b.i.d. (n = 198) for 7 days. MAIN OUTCOME MEASURES: Primary measures of efficacy were Patient's Assessment of Ankle Pain Visual Analogue Scale (VAS) and Patient's Global Assessment of Ankle Injury. Secondary efficacy measures included Physician's Global Assessment of Ankle Injury, Patient's Return to Normal Function/Activity, and Patients' and Physicians' Satisfaction Assessments. Adverse events (AEs) were reported by investigators during the study. RESULTS: For the primary endpoints at day 4, the mean pain VAS scores were 31.9 mm +/- 1.96 for celecoxib and 29.0 mm +/- 1.91 for naproxen, and the responder rate for Patient's Global Assessment of Ankle Injury was 71% in the celecoxib group and 72% in the naproxen group, differences that were not statistically significant. In addition, noninferiority analysis demonstrated treatment differences that were within prespecified minimal clinical important differences. Gastrointestinal AEs were the most common AE, accounting for 14% in the celecoxib group and 21% in the naproxen group. The incidence of dyspepsia was 3% for celecoxib compared with 12% for naproxen (P = 0.032). CONCLUSIONS: Celecoxib is as effective as naproxen in treating acute first-degree or second-degree ankle sprains but causes significantly less dyspepsia.