Comparative plaque removal efficacy of a new children's powered toothbrush and a manual toothbrush: Randomized, single use clinical study.

PURPOSE: To compare the plaque removal efficacy of a new children's powered toothbrush to a children's manual toothbrush. METHODS: 55 subjects aged 5-8 years old, who met entry criteria, participated in this single-center, two-cell, examiner-blind, randomized, crossover, single use clinical study. Subjects brushed at home with their first assigned toothbrush and fluoride toothpaste, under supervision of a parent or legal guardian, at least once daily for 2 minutes during a 1-week acclimation period. After refraining from oral hygiene for 12-16 hours, and from eating and drinking for 4 hours, subjects returned to the clinical site where they were assessed for plaque using the Rustogi Modified Navy Plaque Index (RMNPI). Subjects then brushed their teeth with their assigned toothbrush and toothpaste for 2 minutes and plaque levels were reassessed. Subjects were then given their second assigned toothbrush and the acclimation period and clinical site visit were repeated. Safety-in-use was also assessed during each clinic visit. Differences between pre-and post-brushing scores were analyzed for each toothbrush and between toothbrush groups for whole mouth plaque and 12 subset sites using baseline adjusted ANCOVA. RESULTS: Both toothbrushes significantly (P< 0.0001) reduced whole mouth and 12 subset site plaque scores from the pre-brushing baseline. Between treatment comparisons showed that use of the powered toothbrush resulted in statistically significant reductions in whole mouth plaque (55%, P< 0.0001) and in 12 subset site scores (40-208%) compared to the manual brush. This clinical study showed that brushing with a new children's powered toothbrush was safe and significantly more effective than brushing with a manual toothbrush in reducing whole mouth plaque scores, as well as plaque scores at a range of subset sites in the mouth. CLINICAL SIGNIFICANCE: This new powered toothbrush may enable children to safely achieve significant and meaningful improvements in oral hygiene compared to brushing with a manual toothbrush.

The effects of two baking-soda toothpastes in enhancing mechanical plaque removal and improving gingival health: A 6-month randomized clinical study.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of two fluoride toothpastes containing baking soda (35% and 20%) with a fluoride toothpaste control. METHODS: 319 subjects, who met entry criteria, participated in this single-center, three-cell, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed at baseline, and after 6 weeks, 3 and 6 months. RESULTS: All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points. After 6 months use, the 35% and 20% baking soda toothpastes had reduced MGI, GBI and PI by 15.0%, 46.9%, and 18.3%, and 9.4%, 25.9%, and 12.4%, respectively, compared to the control. In addition, the 35% baking soda toothpaste had reduced (P≤ 0.0005) MGI, GBI, and PI by 6.2%, 28.4%, and 6.8%, respectively, compared to the 20% baking soda toothpaste. This clinical study showed that brushing with fluoride toothpastes containing baking soda at 35% and 20% reduces plaque, gingival inflammation and bleeding more effectively than regular fluoride toothpaste. Further, it showed that 35% baking soda toothpaste was more effective in reducing these parameters than 20% baking soda toothpaste. CLINICAL SIGNIFICANCE: Fluoride toothpastes containing 20% or more baking soda can provide significant and meaningful gingival health benefits when used regularly as an adjunct to tooth brushing.

Enhanced plaque removal to improve gingival health: 3-month randomized clinical study of the effects of baking soda toothpaste on plaque and gingivitis.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of a fluoride toothpaste with 20% baking soda and a fluoride toothpaste control. METHODS: 159 subjects, who met the entry criteria, participated in this single-center, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed after 4, 8, and 12 weeks use of the assigned test or control toothpaste. After 12 weeks, participants resumed 4 weeks of their customary oral hygiene after which they were re-evaluated using the same measures. RESULTS: Both toothpastes statistically significantly reduced MGI, GBI, and PI versus baseline at all-time points. Brushing with the 20% baking soda toothpaste statistically significantly reduced MGI, PI, and GBI compared to the control toothpaste at all time points. After 12 weeks, the reductions in MGI, PI, and GBI were 12.6%, 9.6%, and 44.2%, respectively. After the 4-week customary oral hygiene period, the benefits of the study period had begun to diminish, but statistically significant reductions in MGI and GBI for the test versus control were still evident. This 3-month clinical study shows that brushing with fluoride toothpaste containing 20% baking soda reduces dental plaque and concurrently reduces gingival inflammation and bleeding compared to toothpaste with fluoride alone. CLINICAL SIGNIFICANCE: Fluoride toothpaste with 20% baking soda has the potential to offer multiple oral health benefits when used as an adjunct to regular tooth brushing and, therefore, may be confidently recommended to patients.

Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial.

Background: The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets.Objective: The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults.Methods: Thirty healthy men and women, 34.0 ± 11.4 years of age and Body Mass Index (BMI) 24.5 ± 3.6 kg/m2 completed the randomized examiner-blind, comparator controlled, cross-over trial with two sequences: gummy (1000 mg) to caplet (1000 mg) or caplet to gummy. Intake of foods fortified with Vitamin C was restricted 7 days prior to each dosing. Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 h post-dose for plasma and leukocytes; and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post-dose for L-ascorbic acid analysis.Results: Vitafusion® Power C gummy and comparator caplet demonstrated similar plasma absorption profiles as there were no significant differences in plasma L-ascorbic acid total Area Under the Curve (AUC)0-24h, and Tmax between gummy and caplet. The caplet did elicit a significantly higher Cmax than the gummy (p < 0.05), however, the difference was numerically small. Leukocyte L-ascorbic acid total AUC0-24h and Cmax were not significantly different between gummy and caplet, however Tmax of the gummy group was significantly longer (p = 0.012). Urinary L-ascorbic acid levels were also not significantly different between gummy and caplet. There were no serious adverse events and safety parameters remained within normal clinical range for both products.Conclusion: Vitafusion® Power C gummy exhibited similar Vitamin C absorption and bioavailability to a comparator caplet in healthy adults and were considered bioequivalent.

Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

CONTEXT: The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. OBJECTIVE: This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. MATERIALS AND METHODS: The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. RESULTS: The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control product (Arm & Hammer Free & Clear) and other nonirritant controls. In the Wrist Band Wear test, exposure to laundered fabrics under exaggerated conditions gave similar results for the test and control products, with no objective signs of skin irritation, and no self-reported persistent adverse sensory effects. Very mild, transient and isolated sensory effects were noted in daily diaries by a small proportion of subjects, and were similar for the test and control products. The Safety In-Use tests evaluated 4-week exposure to product and laundered fabrics under realistic use conditions. There were no clinically objective signs of skin irritation, and reports of transitory, mild sensory effects were minimal and similar for the test and controls. DISCUSSION AND CONCLUSION: A comprehensive skin safety program on a lightly scented sensitive skin laundry formulation (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent) conducted among panels of self-assessed sensitive skin subjects demonstrated that the presence of a light fragrance did not adversely impact skin compatibility in any of the testing protocols when the product was compared to a similar product with no fragrance. The lightly fragranced product demonstrated overall skin compatibility and mildness when tested in a self-assessed sensitive skin population, and compared favorably to currently marketed sensitive skin products.

Beliefs about women's vibrator use: results from a nationally representative probability survey in the United States.

Women's vibrator use is common in the United States, although little is known about beliefs about its use. Elicitation surveys and interviews informed the development of a 10-item scale, the Beliefs About Women's Vibrator Use Scale, which was administered to a nationally representative probability sample of adults ages 18 to 60 years. Most women and men held high positive and low negative beliefs about women's vibrator use. Women with positive beliefs reported higher Female Sexual Function Index scores related to arousal, lubrication, orgasm, satisfaction, and pain (indicating less pain).

Vibrator use among heterosexual men varies by partnership status: results from a nationally representative study in the United States.

This nationally representative study documents that vibrator use among heterosexually identified men in the United States is common, with 43.8% reporting use of a vibrator at some point in their lives, with most vibrator use by heterosexual men occurring within the context of sexual interactions with a female partner. Approximately 94% of male vibrator users reported that they had used a vibrator during sexual play with a partner, and 82% reported that they had used a vibrator during sexual intercourse. These data support the work of therapists and educators who often make recommendations for the incorporation of vibrators into partnered relationships.

Women's vibrator use in sexual partnerships: results from a nationally representative survey in the United States.

Little is known about women's use of vibrators within sexual partnerships. Data were collected from a population-based, cross-sectional survey of 2056 women aged 18-60 years in the United States. Partnered vibrator use was common among heterosexual-, lesbian-, and bisexual-identified women. Most vibrator users indicated comfort using them with a partner and vibrator use was related to positive sexual function as measured by the Female Sexual Function Index (FSFI). In addition, partner knowledge and perceived liking of vibrator use was a significant predictor of sexual satisfaction for heterosexual women (p < .01). Clinical and research implications are discussed.

Prevalence and characteristics of vibrator use by men in the United States.

INTRODUCTION: While vibrating products have been recommended by clinicians for the treatment of male sexual dysfunctions, knowledge is lacking with regard to the prevalence of vibrator use among men in the United States, the characteristics of men who use vibrators, and whether there are relations between vibrator use and sexual function among men. AIMS: To establish lifetime and recent prevalence rates for vibrator use by men in the United States, to document the characteristics of men who use vibrators and their reasons for using vibrators, and to explore relations between men's vibrator use and sexual function. METHODS: During April 2008, data were collected from a population-based cross-sectional survey of 1,047 men aged 18-60 years in the United States. Analyses were conducted using post-stratification data weights. MAIN OUTCOME MEASURE: Measures included sociodemographics, health status and health-related behaviors, sexual behaviors, vibrator use, and sexual function. RESULTS: For both solo and partnered sexual activities, the prevalence of men who had incorporated a vibrator into sexual activities during their lives was 44.8%, with 10.0% having done so in the past month, 14.2% in the past year, and 20.5% over 1 year ago. Men who had used vibrators, particularly those with more recent use, were more likely to report participation in sexual health promoting behaviors, such as testicular self-exam. Men who had used vibrators recently also scored higher on four of the five domains of the International Index of Erectile Function (erectile function, intercourse satisfaction, orgasmic function, and sexual desire). CONCLUSIONS: Among men in the United States, vibrator use during solo and partnered sexual interactions is common and is associated with a wide array of positive sexual health characteristics. Future research should continue to explore ways in which men incorporate vibrators into solo sexual acts, partnered sexual play, and sexual intercourse.

Prevalence and characteristics of vibrator use by women in the United States: results from a nationally representative study.

INTRODUCTION: Although vibrators are commonly recommended by clinicians as adjunct to treatment for female sexual dysfunction, and for sexual enhancement, little is known about their prevalence or correlates of use. AIM: The aim of this study was to determine the lifetime and recent prevalence of women's vibrator use during masturbation and partnered sex, and the correlates of use related to sociodemographic variables, health behaviors, and sexual function. METHODS: A nationally representative sample of 3,800 women aged 18-60 years were invited to participate in a cross-sectional Internet-based survey; 2,056 (54.1%) participated. MAIN OUTCOME MEASURES: The prevalence of vibrator use, the relationship between vibrator use and physical and psychological well-being (as assessed by the Centers for Disease Control and Prevention [CDC] Healthy Days measure) and health-promoting behaviors, the relationship between vibrator use and women's scores on the Female Sexual Function Index, and an assessment of the frequency and severity of side effects potentially associated with vibrator use. RESULTS: The prevalence of women's vibrator use was found to be 52.5% (95% CI 50.3-54.7%). Vibrator users were significantly more likely to have had a gynecologic exam during the past year (P < 0.001) and to have performed genital self-examination during the previous month (P < 0.001). Vibrator use was significantly related to several aspects of sexual function (i.e., desire, arousal, lubrication, orgasm, pain, overall function) with recent vibrator users scoring higher on most sexual function domains, indicating more positive sexual function. Most women (71.5%) reported having never experienced genital symptoms associated with vibrator use. There were no significant associations between vibrator use and participants' scores on the CDC Healthy Days Measures. CONCLUSIONS: Vibrator use among women is common, associated with health-promoting behaviors and positive sexual function, and rarely associated with side effects. Clinicians may find these data useful in responding to patients' sexual issues and recommending vibrator use to improve sexual function. Further research on the relationships between vibrator use and sexual health is warranted.

A four-week clinical study to evaluate and compare the effectiveness of a baking soda dentifrice and an antimicrobial dentifrice in reducing plaque.

OBJECTIVE: To evaluate and compare the effectiveness in reducing plaque of a fluoride dentifrice containing baking soda and a non-baking soda fluoride dentifrice containing an antimicrobial (triclosan/copolymer) system after a single brushing and over a four-week period of daily brushing. METHODS: A total of 207 subjects completed this randomized, blinded, parallel-group clinical study. Twenty-four hour plaque buildup was scored at baseline and after two and four weeks of twice-daily use of the products. Additionally, controlled single brushing with the assigned dentifrice, followed by post-brushing plaque assessment, was performed at the start (baseline visit) and end (Week-4 visit) of the study. Plaque was scored using the Turesky, et al. modification of Quigley-Hein Index at six sites per tooth, according to Soparkar's modification. RESULTS: Mean baseline whole mouth plaque scores for the baking soda and triclosan dentifrice groups were 2.90 +/- 0.40 and 2.90 +/- 0.39, respectively, and the difference was not statistically significant. Within-group analysis showed that both products significantly reduced the amount of plaque over the four-week period (p < 0.001). Between-group analysis showed that brushing with the baking soda dentifrice exhibited significantly greater reduction in plaque scores (p < 0.001) after two and four weeks of brushing as compared to the triclosan dentifrice. After four weeks, the mean plaque reduction for the baking soda dentifrice group (0.34 +/- 0.32) was 2.22-fold greater than that observed for the triclosan dentifrice group (0.15 +/- 0.24). Similarly, single brushing with the baking soda dentifrice showed a 1.88- to 2.08-fold greater pre- to post-brushing plaque difference as compared to the triclosan dentifrice at the baseline visit (mean plaque reduction: baking soda 0.54 +/- 0.26; triclosan 0.28 +/- 0.18; ratio 1.88X) and Week-4 visit (baking soda 0.47 +/- 0.21; triclosan 0.23 +/- 0.15; ratio 2.08X). Similar to the whole mouth scores, evaluation of various tooth sites (facial, lingual, proximal, and gingival) showed a significantly greater reduction in plaque scores for brushing with the baking soda dentifrice as compared to brushing with the triclosan dentifrice. CONCLUSION: The results of this study indicate that the baking soda dentifrice was more effective than the non-baking soda, antimicrobial dentifrice in plaque removal after a single tooth brushing, and in maintaining significantly lower plaque levels during a four-week period of twice daily, unsupervised tooth brushing.

Enhancement of plaque removal efficacy by tooth brushing with baking soda dentifrices: results of five clinical studies.

OBJECTIVE: An earlier clinical study demonstrated that brushing with a commercial Arm & Hammer dentifrice containing baking soda physically removed significantly more plaque than brushing with either of two commercial dentifrices which did not contain baking soda. However, little has been done to confirm these results and to compare baking soda-containing dentifrices with more recently commercialized non-baking soda dentifrice formulations. The objective of this study was to compare commercial dentifrices containing 20% to 65% baking soda and commercial dentifrices without baking soda in enhancing plaque removal efficacy of tooth brushing. METHODS: Five randomized, controlled, blinded, crossover clinical studies were performed among healthy adult volunteers who provided informed consent. After approximately 24 hours without oral hygiene, subjects with sufficient plaque were enrolled in the study phase. Plaque was scored before and after supervised brushing for one minute using the Turesky, et al. modification of the Quigley-Hein Plaque Index at six sites per tooth according to Soparkar's modification as described by Lobene, et al. In each study, wash-out periods with a regular dentifrice not evaluated in the study separated each product treatment. RESULTS: In all studies, every dentifrice exhibited a significant (p < 0.0001) reduction in 24-hour plaque scores. Between-group comparisons of whole mouth plaque scores in all five studies demonstrated that brushing with baking soda dentifrices resulted in statistically greater (p < 0.01) reductions in whole mouth mean plaque scores than brushing with dentifrices that did not contain baking soda. Results on other tooth surfaces, such as facial, lingual, proximal, and gingival surfaces also demonstrated statistically greater (p < 0.05) reductions in mean plaque scores for the baking soda-containing dentifrices as compared to the baking soda-free dentifrices. In three of the studies comparing different levels of baking soda, brushing with dentifrices with higher concentrations of baking soda consistently removed numerically more plaque than those containing lower levels. In one of these three studies, the difference in plaque removal between the baking soda dentifrices reached statistical significance. The results suggest a positive relationship between plaque removal efficiency and baking soda concentration. CONCLUSION: The collective results from the five controlled clinical studies on over 270 subjects reported in this paper, consistently demonstrate that Arm & Hammer baking soda dentifrices enhanced plaque removal effectiveness of tooth brushing to a significantly greater extent than the non-baking soda dentifrice products.

Extrinsic tooth stain removal efficacy of a sodium bicarbonate dual-phase dentifrice containing calcium and phosphate in a six-week clinical trial.

OBJECTIVE: The objective of this clinical investigation was to evaluate the effectiveness in removing existing extrinsic tooth stains of a sodium bicarbonate (baking soda), dual-phase dentifrice containing calcium and phosphate (Test Dentifrice), when compared to a commercial hydrated silica dentifrice (Control Dentifrice), during a six-week period of normal, unsupervised use. METHODOLOGY: This investigation was a double-blind comparison of two equivalent, parallel groups of subjects assigned to use different dentifrices for six weeks. A total of 108 adult male and female subjects qualified for the trial based on the presence of existing extrinsic tooth stains and other inclusion/exclusion criteria. The two groups were balanced for gender, tobacco use, and extrinsic tooth stain scores, and randomly assigned the Test or Control dentifrices. All subjects were instructed to brush their teeth twice daily using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the duration of the study. Although product usage was unsupervised after the baseline visit, subjects maintained a treatment diary, and product consumption was monitored to estimate compliance. Oral soft and hard tissue and extrinsic stain assessments (Modified Lobene Stain Index) for each subject were conducted at baseline and after two, four, and six weeks of product use. RESULTS: A total of 107 subjects complied with the protocol and completed the six-week study. Compared to baseline, at the two-, four-, and six-week examinations the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain. In contrast, the Control Dentifrice group did not attain significant reductions from baseline at any of the exams. At both the four-week and six-week examinations, the Test Dentifrice group had significantly lower levels of extrinsic tooth stain than the Control Dentifrice group. CONCLUSION: A sodium bicarbonate, dual-phase dentifrice containing calcium and phosphate demonstrated statisically significant efficacy in removing naturally acquired, extrinsic tooth stain, and was significantly more effective for stain removal than a commercially available, hydrated silica dentifrice.

Intraoral evaluation of mineralization of cosmetic defects by a toothpaste containing calcium, fluoride, and sodium bicarbonate.

New dual-phase fluoride toothpastes that contain soluble calcium, phosphate, and baking soda have recently been introduced into the market. These toothpastes are designed to fill in small surface defects in tooth enamel and thereby enhance tooth esthetics such as gloss. This two-part study was designed to assess these superficial mineralizing effects from using one of these products compared with an experimental calcium-containing, bicarbonate-free formulation and a conventional fluoride toothpaste using an intraoral model. Enamel specimens with 4 types of defects were mounted into an intraoral appliance and placed in the mouths of volunteers for 1 month. The four types of defects were whitening toothpaste abrasion, coarse abrasion, natural dimpling, and acid etching. Before and after intraoral exposure, scanning electron microscope photographs of the specimens were made. The surface microhardness of the acid-etched specimens also was determined. The volunteers brushed their specimens twice daily with one of three randomly assigned toothpastes. The toothpastes were a two-phase, calcium-containing, bicarbonate-based toothpaste; an experimental, two-phase, calcium-containing, bicarbonate-free toothpaste; and a conventional toothpaste. Only the calcium-containing toothpastes showed unequivocal signs of mineral deposition into surface defects, leading to smoothing of the enamel. All three products significantly increased the hardness of the etched enamel, presumably because of fluoride. However, only the two calcium-containing toothpastes gave significantly greater hardness increases than the conventional toothpaste; the specimens treated with a conventional toothpaste were indistinguishable from those treated with saliva.

Clinical efficacy evaluation of calcium, phosphate, and sodium bicarbonate on surface-enamel smoothness and gloss.

This clinical study evaluated the effectiveness of a fluoride dentifrice containing calcium, phosphate, and sodium bicarbonate for improving surface-enamel smoothness and gloss relative to a commercially available fluoride and silica-containing dentifrice. Balancing for baseline surface-enamel roughness and gloss, 113 healthy adult volunteers who met the inclusion criterion for daily acidic drink consumption were randomized to receive 1 of the 2 products. Subjects brushed their teeth using the assigned dentifrice and a soft-bristled adult toothbrush for 1 minute twice daily for 3 months. Surface-enamel roughness and gloss were evaluated at baseline and after 1 and 3 months of brushing twice daily. Within-treatment comparisons showed longitudinal improvement by the test dentifrice in tooth-surface roughness and gloss at the 1-month and 3-month examinations. After 3 months of use, the test dentifrice exhibited a highly significant improvement in gloss (23.4%, P < .0001) and surface roughness (13.7%, P < .0001) over baseline. The control dentifrice showed no significant improvement longitudinally in either parameter. Between-group comparisons adjusted for baseline demonstrated a significantly (P < .0001) greater improvement in tooth-surface roughness and gloss for the test dentifrice. The results indicate that the fluoride dentifrice containing calcium, phosphate, and sodium bicarbonate is effective in improving tooth-surface smoothness and gloss with regular use.

Comparison of a dual-phase fluoride toothpaste containing calcium, phosphate, and sodium bicarbonate with a regular fluoride toothpaste on calculus formation.

This clinical study compared the effect on dental calculus formation of a dual-phase fluoride dentifrice containing sodium bicarbonate, calcium, and phosphate with that of a regular dentifrice using a short-term clinical model in which calculus formation was facilitated. A total of 87 adult volunteers completed this study, which was a double-blind, parallel-group design, consisting of 2-week pretrial and trial periods separated by a washout period. A partial-mouth technique was used wherein the lower anterior teeth were protected from brushing by a custom-fitted toothshield, which doubled as an applicator for an undiluted dentifrice, twice daily. Calculus was measured on the labial/lingual surfaces of six lower anterior teeth by the Volpe-Manhold Index (V-MI). Subjects used a non-tartar-control dentifrice during the pretrial period to determine calculus formation rates, and these V-MI scores were used as baseline data for random allocation to either a control or test product for the trial period. Subjects who were accepted into the study, based on existing tartar deposits, readily formed calculus during the pretrial period using the toothshield method. During the trial period, subjects who were assigned the test dentifrice had comparable amounts of calculus accumulation to those who used the control dentifrice. However, subjects in the test dentifrice group had significantly lower (16%) calculus scores on lingual surfaces than those in the control group. Intragroup comparisons of V-MI data from the pretrial period with those from the trial period provided similar overall results to the comparisons between groups. This study demonstrated that a dual-phase baking soda dentifrice containing calcium and phosphate did not increase calculus accumulation relative to a regular dentifrice when used by adults with a propensity for developing calculus.

Efficacy and tolerability of an intraoral benzocaine patch in the relief of spontaneous toothache pain.

OBJECTIVE: In this randomized, double-blind, placebo-controlled clinical trial, the effectiveness and tolerability of a novel intraoral benzocaine patch was evaluated in 60 patients who presented to the Dental School's emergency clinic with spontaneous toothache pain of at least a moderate intensity. METHODOLOGY: Mucoadhesive patches, containing either 12 mg of benzocaine or a matching placebo, were applied approximately two millimeters apical to the mucogingival junction of the symptomatic tooth and remained in place for 60 minutes. Pain intensity (0-4 scale) and pain relief (0-4 scale) were recorded every five minutes through 30 minutes, and then every ten minutes through the 90-minute time point. The onset times of first perceptible and meaningful relief were recorded using two stopwatches. The occurrence of adverse events was also monitored. RESULTS: While the benzocaine patches were numerically superior to the placebo patches at all time points with respect to pain relief, PID (pain intensity difference) and their summed measures (TOTPAR and SPID scores), an analysis of covariance revealed no significant differences between treatments. Survival analysis indicated that the percentage of patients reporting meaningful pain relief by 30 minutes was significantly (p < 0.05) greater in the benzocaine group than in the placebo group (77% for benzocaine and 47% for placebo). The median onset times to first perceptible and meaningful relief were 5.4 and 18.1 minutes in the benzocaine group, and 7.8 and 30.4 minutes in the placebo group. Only two side effects (headache) were reported in the entire study. CONCLUSION: Although the results of the present study were promising, further research on this novel delivery system of benzocaine is warranted to firmly establish efficacy in patients with spontaneous toothache pain.