The pediatric heart network's study on long-term outcomes of children with HLHS and the impact of Norwood Shunt type in the single ventricle reconstruction trial cohort (SVRIII): Design and adaptations.

BACKGROUND: The Single Ventricle Reconstruction (SVR) Trial was the first randomized clinical trial of a surgical approach for treatment of congenital heart disease. Infants with hypoplastic left heart syndrome (HLHS) and other single right ventricle (RV) anomalies were randomized to a modified Blalock Taussig Thomas shunt (mBTTS) or a right-ventricular-to-pulmonary-artery shunt (RVPAS) at the time of the Norwood procedure. The aim of the Long-term Outcomes of Children with HLHS and the Impact of Norwood Shunt Type (SVR III) study is to compare early adolescent outcomes including measures of cardiac function, transplant-free survival, and neurodevelopment, between those who received a mBTTS and those who received an RVPAS. METHODS: Transplant-free survivors of the SVR cohort were enrolled at 10 to 15 years of age for multifaceted in-person evaluation of cardiac function (cardiac magnetic resonance [CMR], echocardiogram and exercise test) and neurodevelopmental evaluation. Right ventricular ejection fraction measured by CMR served as the primary outcome. Development of arrhythmias, protein losing enteropathy, and other comorbidities were assessed through annual medical history interview. Through the course of SVR III, protocol modifications to engage SVR trial participants were designed to enhance recruitment and retention. CONCLUSIONS: Evaluation of long-term outcomes will provide important data to inform decisions about the shunt type placed at the Norwood operation and will improve the understanding of cardiovascular and neurodevelopmental outcomes for early adolescents with HLHS.

Plaque and gingivitis reduction efficacy of an advanced pulsonic toothbrush: a 4-week randomized and controlled clinical trial.

PURPOSE: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period. METHODS: This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior. RESULTS: Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.

Clinical assessment of extrinsic stain removal efficacy with a new Pulsonic toothbrush.

OBJECTIVE: To assess the extrinsic stain removal benefit of two different power toothbrushes: an experimental Oral-B Pulsonic rechargeable toothbrush and a positive control Sonicare FlexCare toothbrush. METHODS: This was a randomized, positive-controlled, examiner-blind, two-treatment, parallel group, two-week study. A Lobene stain index was performed at baseline on the facial surfaces of the anterior teeth. Subjects were randomized to one of two treatment groups: Pulsonic or FlexCare. Both groups were assigned the same fluoride dentifrice, and were instructed to brush their teeth twice per day for two minutes with the assigned toothbrush and dentifrice in front of a mirror. A further Lobene stain index was performed following two weeks of brushing. RESULTS: A highly significant reduction (p < 0.001) in mean Lobene composite scores after two weeks was found for both the Pulsonic treatment group and the FlexCare treatment group (median reduction of 94.4% and 90.7%, respectively). Both treatment groups also showed a highly significant (p < 0.001) reduction in extent and intensity scores. No significant treatment group differences were seen in the reduction in mean Lobene scores (p > 0.1). CONCLUSION: Both the experimental Pulsonic and the positive control FlexCare power toothbrushes showed highly effective stain removal efficacy relative to baseline following two weeks of brushing. Stain removal efficacy did not differ significantly between brushes.

Clinical evaluation of the effects of a sonic toothbrush with ultrasound waveguide in disrupting plaque with and without bristle contact.

PURPOSE: To assess the in vivo plaque removal efficacy of the newly marketed sonic/ultrasonic toothbrush. Plaque removal resulting from the toothbrush being held approximately 3 mm from the tooth surface was compared versus a no brushing control. Also, plaque removal resulting from the brush being used according to the manufacturer's instructions was compared versus a control of using the brush (with power turned off) like a manual toothbrush would be used. METHODS: This was a replicate use, four-treatment, examiner-blind, randomized, eight-period crossover design single brushing plaque study involving 31 subjects. The four treatment regimens consisted of (1) brushing for 2 minutes with the Ultreo powered toothbrush according to manufacturer's instructions, (2) brushing for 2 minutes with the Ultreo toothbrush (power turned off) using the brush like a manual toothbrush, (3) having a trained dental hygienist hold the Ultreo toothbrush head 3 mm from tooth surfaces for a total of 2 minutes, or (4) swishing with a dentifrice slurry for 1 minute in the absence of toothbrushing. For each subject, an experienced, calibrated plaque examiner performed the Turesky Modified Quigley-Hein Plaque Index prior to brushing and following brushing. The difference (baseline minus post-regimen) in average scores was calculated for each subject. The difference scores were analyzed for treatment regimen differences using a mixed model ANCOVA (with baseline whole-mouth average score as the covariate and subjects considered random) for a crossover design. RESULTS: Adjusted mean plaque removal scores (baseline plaque score minus post-brushing plaque score) were 0.052 for swishing with a dentifrice slurry, 0.058 for the dental hygienist holding the Ultreo toothbrush approximately 3 mm from tooth surfaces, 0.536 for the Ultreo toothbrush used according to manufacturer's instructions and 0.666 for the Ultreo toothbrush (power turned off) used like a manual toothbrush. The difference between the Ultreo toothbrush held approximately 3 mm from tooth surfaces and swishing with a dentifrice slurry was not statistically significant (P = 0.808). The adjusted mean plaque removal score for the Ultreo toothbrush (power turned off) used like a manual toothbrush was statistically significantly (P < 0.001) greater than the corresponding score for the Ultreo toothbrush used per manufacturer's instructions. Ultreo used like a manual toothbrush had an adjusted mean plaque removal score that was 12.4% greater than that for Ultreo used per manufacturer's instructions. Finally, plaque removal scores for the Ultreo toothbrush used per manufacturer's instructions and used like a manual toothbrush were statistically significantly (P < 0.001) greater than plaque removal scores for the non-brushing treatment regimens.

Plaque removal efficacy of an advanced rotation-oscillation power toothbrush versus a new sonic toothbrush.

PURPOSE: To evaluate the plaque removal efficacy and safety of an advanced rotation-oscillation power toothbrush relative to a newly-introduced sonic toothbrush. METHODS: This study used a randomized, examiner-blind, two-treatment, four-period, four-sequence crossover design. Subjects received both toothbrushes (Oral-B Triumph and Sonicare FlexCare) and a standard dentifrice from the study site and used each toothbrush at home during an acclimation phase prior to their plaque measurement visits. After abstaining from all oral hygiene for 24 hours, subjects returned to the study site and were assessed with the Rustogi Modified Navy Plaque Index. They then brushed for 2 minutes with their first randomly-assigned toothbrush and post-brushing plaque scores were recorded. This procedure was followed for three additional study visits, with subjects using their normal at-home toothbrush and dentifrice for the 2- to 5-day washout periods between visits. Subjects always abstained from all oral hygiene for 24 hours prior to their visits. RESULTS: 45 subjects completed the study. Both brushes were found to be safe and both significantly reduced plaque after a single brushing. Oral-B Triumph was statistically significantly (P < 0.0001) more effective in plaque removal than Sonicare FlexCare for whole mouth plaque scores, gingival marginal plaque scores and interproximal plaque scores. Compared to Sonicare FlexCare, the adjusted mean plaque reduction scores for Oral-B Triumph were 21%, 23% and 22% greater for whole mouth, marginal and interproximal areas, respectively.

A comparative clinical study of the plaque removal efficacy of an oscillating/rotating power toothbrush and an ultrasonic toothbrush.

OBJECTIVE: To evaluate the safety and efficacy of two power toothbrushes in the removal of dental plaque following a single brushing. METHODS: The study employed a two-treatment, examiner-blind, randomized, four-period crossover design. A total of 25 generally healthy adult subjects were enrolled into the study. Test products were an oscillating/rotating power toothbrush (Oral-B Triumph Professional Care 9000) and a newly marketed sonic toothbrush with an ultrasound waveguide (Ultreo). Subjects used each power toothbrush twice during the study following each manufacturer's usage instructions. Clinical examinations using the Turesky Modified Quigley-Hein Plaque Index (TMQHPI) as the primary variable and the Rustogi Modification of the Navy Plaque Index (RMNPI) were performed by calibrated and experienced clinical examiners prior to and following brushing. The difference (baseline minus post-regimen) in average plaque scores was calculated for each subject. The different scores were analyzed for treatment regimen differences using a mixed model analysis of covariance (with baseline whole-mouth average score as the covariate and subjects considered random) for a crossover design. RESULTS: Baseline whole-mouth TMQHPI and RMNPI plaque scores were well balanced between the two treatment groups. Adjusted mean whole-mouth TMQHPI plaque removal (baseline minus post-brushing) scores were 0.604 for the Triumph toothbrush and 0.488 for the Ultreo toothbrush. The Triumph toothbrush provided statistically significantly more plaque reduction that was 23.9% greater than the Ultreo toothbrush (p = 0.0001). The RMNPI examiner detected similar treatment differences in favor of the Triumph toothbrush, with a 16.3% greater plaque reduction than the Ultreo toothbrush (p < 0.0001). Both products were well tolerated with no adverse events reported in the study. CONCLUSION: The results demonstrate superior plaque removal efficacy of the oscillating/rotating Triumph toothbrush versus the Ultreo ultrasonic toothbrush.

Improved plaque removal efficacy with a new manual toothbrush.

AIM: To compare the safety and efficacy of two manual toothbrushes, Oral-B Exceed and Asian Colgate 360 masculine, in removing plaque. METHODS AND MATERIALS: The study used an examiner-blind, two-treatment, randomized, four-period (visits) crossover design. At the first visit, subjects received a baseline plaque examination; plaque was scored using the Rustogi et al. Modified Navy Plaque Index (RMNPI) and the Turesky et al. Modified Quigley-Hein Plaque Index (TQHPI). Subjects used their assigned toothbrush for one minute. Post-brushing plaque was assessed. The following three visits were separated by an interval of two to six days. At each visit, subjects were assigned brushes according to their treatment sequence and plaque was scored per the first visit. RESULTS: Forty-eight subjects were enrolled in the study; 47 were included in the analysis. Both brushes were found to be safe and both significantly reduced plaque after a single brushing. The Oral-B Exceed was significantly (p<0.001) better than the Asian Colgate 360 masculine at removing whole mouth plaque (18.1% using TQHPI; 9% using RMNPI). The Oral-B Exceed was also significantly better at removing marginal (p=0.001) and approximal (p=0.022) plaque. CONCLUSION: The Oral-B Exceed brush removed significantly more whole mouth, approximal, and gingival margin plaque than the Asian Colgate 360 masculine in a four-period crossover clinical comparison.

Impact of a novel power toothbrush with SmartGuide technology on brushing pressure and thoroughness.

AIM: Toothbrushing effectiveness can be improved with at-home reinforcement of proper technique. This study evaluated the ability of a power brush with a wireless remote display (Oral-B Triumph with SmartGuide) to improve brushing force and thoroughness. METHODS AND MATERIALS: At baseline, 61 pre-screened subjects were videotaped while brushing. The wireless display was also videotaped. Subjects were then randomized to the power brush alone or the power brush with the wireless display. After 30 days of home use, subjects returned and brushed for two minutes using a two-way mirror. Brushing behavior and the wireless display were videotaped. RESULTS: Fifty-eight subjects were included in the pressure sensor analysis. The reduction in pressure sensor activation time at day 30 versus baseline was 88.5% for the power brush with wireless display and 53.4% for the power brush alone. The difference between groups was statistically significant in favor of the power brush with display (p=0.034). Forty-six subjects were included in the brushing thoroughness assessment. Subjects using the power brush with the wireless display showed statistically significantly more thorough brushing across the dentition and lingual/buccal surfaces relative to baseline. The power brush alone did not show a significant difference relative to baseline. CONCLUSION: Subjects using the power brush with the wireless display brushed with less force than subjects using the power brush alone after 30 days of home use. CLINICAL SIGNIFICANCE: The power brush with the wireless display can be incorporated in patients' home care routine to improve brushing technique, including brushing pressure and thoroughness.

A clinical evaluation of extrinsic stain removal: a rotation-oscillation power toothbrush versus a dental prophylaxis.

AIM: To assess extrinsic stain removal efficacy of a power toothbrush and a dental prophylaxis followed by the use of a standardized American Dental Association (ADA) reference manual toothbrush. METHODS AND MATERIALS: This was a randomized, positive-controlled, examiner-blind, parallel group, two-week study. A Lobene stain examination was performed at baseline. Subjects were randomized to one of two treatment groups: Group 1: Oral-B Vitality Pro White power toothbrush or Group 2: Subjects receiving a dental prophylaxis then using a standardized ADA reference manual toothbrush. Subjects were instructed to brush their teeth with the assigned toothbrush and a fluoride dentifrice in front of a mirror twice per day for 2 minutes. Stain was reassessed following 2 weeks of brushing. RESULTS: A significant reduction (p <0.001) in mean Lobene composite scores after 2 weeks was found for Group 1 (90.6%) and Group 2 (94.4%). Both groups also showed a significant reduction (p <0.001) in extent and intensity scores. There was no significant group difference in reduction in mean Lobene composite scores (p>0.1). CONCLUSIONS: The Oral-B Vitality Pro White power toothbrush showed effective stain removal at a level similar to receiving an oral prophylaxis followed by the use of an ADA reference manual toothbrush. CLINICAL SIGNIFICANCE: In this small study the Oral-B Vitality Pro White power toothbrush achieved statistically significant stain removal between dental visits.

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.

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.

Comparative clinical trial of two antigingivitis mouthrinses.

PURPOSE: To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses. METHODS: A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance. RESULTS: Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated. CLINICAL SIGNIFICANCE: This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized antiplaque and antigingivitis mouthrinse that contains alcohol.

Dentinal hypersensitivity: a review.

Dentinal hypersensitivity is generally reported by the patient after experiencing a sharp pain caused by one of several different stimuli. The pain response varies substantially from one person to another. The condition generally involves the facial surfaces of teeth near the cervical aspect and is very common in premolars and canines. The most widely accepted theory of how the pain occurs is Brannstrom's hydrodynamic theory, fluid movement within the dentinal tubules. The dental professional, using a variety of diagnostic techniques, will discern the condition from other conditions that may cause sensitive teeth. Treatment of the condition can be invasive or non-invasive in nature. The most inexpensive and efficacious first line of treatment for most patients is a dentifrice containing a desensitizing active ingredient such as potassium nitrate and/or stannous fluoride. This review will address the prevalence, diagnosis, and treatment of dentinal hypersensitivity. In addition the home care recommendations will focus on desensitizing dentifrices.

Plaque removal efficacy of a battery-operated power toothbrush compared to two control manual toothbrushes in single use studies.

PURPOSE: Recently, a power toothbrush (Crest SpinBrush) has been reported to remove plaque more effectively than a manual toothbrush (Colgate Navigator). The objective of these studies was to compare the plaque removal efficacy of two control manual toothbrushes (Colgate Wave and Colgate Plus) to an experimental power toothbrush (Crest SpinBrush). The Colgate Plus has an ordinary flat bristle trim design, while the Colgate Wave has an advanced design multilevel bristle trim for greater interproximal penetration. MATERIALS AND METHODS: Each of these two studies were randomized, controlled, examiner-blind, 4-period crossover designs which examined plaque removal with the experimental toothbrush relative to a control manual toothbrush following a single use in 37 and 35 subjects, respectively. Plaque was scored before and after brushing using the Turesky Modification of the Quigley-Hein Index. RESULTS: In the first study, average baseline plaque scores were 2.88 and 2.89 for the experimental toothbrush and advanced designed manual control toothbrush (Colgate Wave) treatment groups, respectively. With respect to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.70 while the control toothbrush delivered an adjusted mean difference of 0.59. The difference between the brushes was statistically significant (P < 0.001). The experimental toothbrush removed, on average, 19.9% more plaque than the control toothbrush. In the second study, baseline plaque scores averaged 3.07 and 3.04 for the experimental toothbrush and ordinary flat trim manual control toothbrush (Colgate Plus) treatment groups, respectively. With respect to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.87 while the control toothbrush delivered an adjusted mean difference of 0.62. The difference between brushes was statistically significant (P < 0.001). The experimental toothbrush removed, on average, 40.0% more plaque than the control toothbrush.

Dental plaque removal with a novel battery-powered toothbrush.

PURPOSE: To compare the plaque removal efficacy of a positive control power toothbrush (Oral-B Ultra Plaque Remover) to an experimental power toothbrush (Crest SpinBrush) following a single use. MATERIALS AND METHODS: This study was a randomized, controlled, examiner-blind, 2-period crossover design which examined plaque removal with the two toothbrushes following a single use in 38 completed subjects. Plaque was scored before and after brushing using the Turesky Modification of the Quigley-Hein Index. RESULTS: Baseline plaque scores were 1.89 and 1.91 for the experimental toothbrush and control toothbrush treatment groups, respectively. With respect to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.46 while the control toothbrush delivered an adjusted mean difference of 0.45. These results were not statistically significant (P=0.645). A 95% one-sided upper confidence limit on the Ultra Plaque Remover minus SpinBrush difference in amount of plaque removed was calculated as 9.4% of the Ultra Plaque Remover adjusted mean. A common criterion for what is known as an "at least as good as" test is that the 95% one-sided confidence limit on the product difference is below 10% of the control product mean. Using this criterion, the SpinBrush is at least as good as the Oral-B Ultra Plaque Remover. With respect to buccal and lingual surfaces, the experimental toothbrush delivered very similar results relative to the control toothbrush. These results were also not statistically significant (P> 0.564).

Dental plaque removal with two battery-powered toothbrushes.

PURPOSE: To compare the plaque removal efficacy of a positive control power toothbrush (Colgate Actibrush) to an experimental power toothbrush (Crest SpinBrush) following a single use. MATERIALS AND METHODS: This study was a randomized, controlled, examiner-blind, 4-period crossover design which examined plaque removal with the two toothbrushes following a single use in 39 completed subjects. Plaque was scored before and after brushing using the Turesky Modification of the Quigley-Hein Index. RESULTS: Baseline plaque scores averaged 2.18 and 2.16 for the experimental toothbrush and control toothbrush treatment groups, respectively. With respect to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.66 while the control toothbrush delivered an adjusted mean difference of 0.43. This represents an increase of 55% plaque removal relative to the control power toothbrush. The difference between brushes was statistically significant (P < 0.001). With respect to buccal and lingual surfaces, the experimental toothbrush delivered very consistent results relative to the control toothbrush. The differences between brushes were also statistically significant (P < 0.001).

A chewing gum containing 7.5% sodium hexametaphosphate inhibits stain deposition compared with a placebo chewing gum.

The 2-period, randomized, double-blind, placebo-controlled, crossover study compared the stain-prevention and stain-removal benefit of a chewing gum containing 7.5% sodium hexametaphosphate (measured by digital image analysis) with a placebo chewing gum. The results of this study support that sodium hexametaphosphate delivered from a chewing gum prevents dental stain formation and facilitates stain removal, which leads to a perceptible whitening benefit. The long-term clinical benefits of sodium hexametaphosphate delivered from chewing gum have not been reported in the literature.

The prevention of induced stain using two levels of sodium hexametaphosphate in chewing gum.

OBJECTIVE: This study was a randomized, controlled, examiner-blind, four-period crossover design that examined the prevention of induced stain deposition through the use of chewing gums containing either 2.0% or 3.0% sodium hexametaphosphate (Na Hex). METHODOLOGY: The test treatments were an experimental chewing gum containing 2.0% Na Hex, a second experimental chewing gum containing 3.0% Na Hex, a placebo chewing gum (0.0% Na Hex) and no chewing gum. The study was carried out over a four-week period, with each treatment period lasting two days. Treatment periods were separated by a washout period of three to five days. Twelve subjects who met the inclusion and exclusion criteria were given a thorough dental prophylaxis limited to the anterior twelve teeth, and then underwent a baseline digital imaging assessment (DIA) procedure. Each treatment period involved two days of stain induction, which consisted of rinsing for 60 seconds with 10 ml of 0.12% chlorhexidine, followed by chewing with two pellets of the assigned chewing gum for five minutes or by no gum chewing, followed by rinsing with 10 ml of cold tea solution for 60 seconds. This regimen was repeated eight times throughout the day, approximately once an hour. Imaging was completed at baseline and at the end of day 2 of the induced stain regimen. Subjects refrained from any oral hygiene during the two-day stain induction periods. RESULTS: Average baseline L* scores ranged from 76.30 to 76.57. At the end of the two-day stain induction regimen (eight hourly cycles per day) when no gum was chewed ("no gum"), subjects' teeth were 5.18 units darker on average than they were at baseline. At the end of the two-day regimen when the placebo gum was chewed, subjects' teeth were 4.54 units darker on average than they were at baseline. The difference between "no gum" and placebo gum was statistically significant (p = 0.017), and represented a 12.4% reduction in tooth darkness for the placebo gum treatment. Use of the 2.0% Na Hex gum resulted in teeth 3.64 units darker on average versus baseline, and the 3.0% Na Hex gum resulted in teeth 4.02 units darker. Both the 2.0% and 3.0% Na Hex gums resulted in teeth that were statistically significantly less dark (p < or = 0.042) than both the "no gum" and placebo gum treatments. On average, the reduction in tooth darkness for the 2.0% Na Hex gum was 29.7% versus "no gum" and 19.8% versus the placebo gum. The 2.0% Na Hex and 3.0% Na Hex gum treatments did not differ significantly (p = 0.114). CONCLUSION: This study demonstrated that 2.0% and 3.0% levels of Na Hex in a chewing gum prevented the deposition of extrinsic dental stain better than a chewing gum without Na Hex, which in turn prevented the deposition of stain better than no chewing gum.

Short-term impact of a national dental education program on children's oral health and knowledge.

OBJECTIVE: The objective of this four-week, examiner-blind study was to determine the impact of an educational oral health program conducted within a Boys and Girls Club of America in Chicago, Illinois, USA. The educational program focused on the gingival health (gingivitis and plaque) of participating children who were between the ages of six and 15. METHODOLOGY: The multi-week program taught the participants the basics of oral biology and disease, as well as proper oral health prevention, including oral hygiene, dietary modification, and the importance of visiting the dentist. A calibrated examiner measured whole mouth Löe-Silness Gingival Index (GI) and Turesky Modification of Quigley-Hein Plaque Index (PI) at baseline (immediately prior to the initiation of the educational program) and four weeks later. The primary efficacy analysis was based on the change from baseline for 90 subjects who were enrolled at baseline, participated in the educational program, and were examined four weeks later. In addition, subjects completed five questions at baseline and at four weeks to assess their oral health knowledge before and after exposure. RESULTS: Mean baseline GI score was 0.184, while the four-week mean GI score was reduced to 0.140. This represents a 24% reduction in GI score, with p < 0.001. The mean baseline bleeding site score was 9.99, while the four-week mean bleeding score was reduced to 7.97. This represents a 20% reduction in bleeding sites, with p = 0.005. The mean baseline PI score was 3.06, while the four-week mean PI score was reduced to 2.97. This represents a 3% reduction in PI score with p = 0.044. The subject population was found to have statistically significantly (p < 0.001) greater knowledge following the program at week four, with 37% (33 of 90) and 69% (62 of 90) of subjects answering the questions correctly at baseline and week four, respectively. CONCLUSION: Collectively, these data support the role of an educational program in promoting improved oral health in these children over a four-week period.

The relative effectiveness of six powered toothbrushes for dental plaque removal.

During the past three years, a number of new powered toothbrushes have been marketed in the United States. The objective of this study was to compare the single-use plaque removal efficacy of six powered toothbrushes: a new prototype (Crest SpinBrush Pro), Crest SpinBrush, Oral-B Battery, Colgate Motion, Oral-B 3-D Excel, and a Crest experimental toothbrush design. This study was a randomized, controlled, examiner-blind, six-period crossover design, which examined plaque removal with six powered toothbrushes following a single use in 26 subjects. Plaque was scored before and after brushing for one minute using the Turesky, et al. Modification of the Quigley-Hein Index. For statistical comparison, the plaque scores were averaged on a per-subject basis. Each subject had a single whole-mouth average score for baseline and for the exam following a one-minute brushing with their assigned toothbrush. The difference (baseline minus post-brushing) in average scores was calculated and analyzed using an analysis of covariance for a crossover design, with baseline whole-mouth average score as the covariate, and terms in the model for subjects, periods, and treatments. Mean baseline plaque scores ranged from 1.770-1.897 for the six toothbrush treatment groups and were not statistically significantly different. Using the analysis of covariance, with respect to all surfaces examined, the new prototype powered toothbrush (Crest SpinBrush Pro) delivered an adjusted mean difference between baseline and post-brushing plaque scores of 0.544, while the five remaining powered toothbrushes delivered an adjusted mean difference of 0.470-0.497. These results represent 10-16% greater plaque removal for the new prototype powered toothbrush. Overall, the six toothbrushes were not statistically significantly different (p = 0.199). However, results of unadjusted pair-wise comparisons conducted per the study protocol found that the new prototype powered toothbrush removed greater levels of plaque than the Oral-B 3-D Excel, Colgate Motion, and Crest experimental toothbrush (p = 0.028, p = 0.038, and p = 0.028, respectively). With respect to buccal and lingual surfaces, the new prototype powered toothbrush (Crest SpinBrush Pro) delivered very similar results relative to the control toothbrushes. Collectively, the results suggest that the new prototype powered toothbrush may offer enhanced plaque removal efficiency relative to the five other toothbrushes, and be at least as good as the five tested powered toothbrushes.