The erosion protection efficacy of a stabilized stannous fluoride dentifrice: An in situ randomized clinical trial.

PURPOSE: To compare the enamel protection efficacy of a stabilized stannous fluoride dentifrice to a triclosan-containing sodium fluoride dentifrice using a 10-day in situ erosion model, in accordance with the American Dental Association Seal of Acceptance guidelines for enamel erosion control. METHODS: In this single-center, double-blind, randomized, supervised-usage, two-treatment, four-period, crossover study, healthy adult subjects were randomized to a treatment sequence involving the following products: a 0.454% stannous fluoride (1,100 ppm F) dentifrice (Procter & Gamble) and a control dentifrice containing 0.243% sodium fluoride (1,100 ppm F) and 0.3% triclosan (Colgate-Palmolive). Each study period consisted of 10 treatment days. Subjects wore an intra-oral appliance fitted with two polished human enamel samples for 6 hours per treatment day. While wearing the appliance, subjects swished with their assigned dentifrice slurry for 60 seconds twice daily and with 250 ml orange juice over a 10-minute period four times daily. After 10 days, enamel specimens were removed and measured for surface loss using contact profilometry. RESULTS: 36 subjects were enrolled and 33 completed the study (mean age = 41.8 years). The stannous fluoride dentifrice demonstrated 90.3% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.279 µm and 2.877 µm, respectively. Both products were well tolerated. CLINICAL SIGNIFICANCE: The stannous fluoride dentifrice provided significantly greater protection against dental erosion relative to the NaF/triclosan dentifrice.

Randomized in situ clinical trial evaluating erosion protection efficacy of a 0.454% stannous fluoride dentifrice.

OBJECTIVES: To assess the protective effects of a 0.454% stabilized stannous fluoride dentifrice and a marketed triclosan dentifrice against enamel erosion in a 10-day in situ model. METHODS: This was a double-blind, randomized, 2-treatment, 4-period, crossover in situ trial involving healthy adult participants. Participants were randomized to a treatment sequence involving the following products: a highly bioavailable 0.454% stannous fluoride dentifrice (Procter & Gamble) and a marketed dentifrice control containing 0.24% sodium fluoride and 0.3% triclosan (Colgate-Palmolive). Each study period took place over 10 days. Participants wore an intra-oral appliance retaining two polished human enamel samples for 6 hours per day. Two times per day they swished with the assigned dentifrice slurry and four times per day they swished with 250 mL of orange juice (25 mL per minute) over a 10-minute period. Contact profilometry measurements were made for each sample at baseline and day 10 to determine surface change. RESULTS: Thirty-six participants were enrolled and 33 completed the study (mean age = 40.5 years). The stannous fluoride dentifrice demonstrated 93.5% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.097 µm and 1.495 µm, respectively. Both products were well tolerated. CONCLUSION: The stannous fluoride dentifrice demonstrated significantly greater erosion protection efficacy relative to the NaF/triclosan dentifrice in this randomized in situ clinical trial.

Erosion protection efficacy of a 0.454% stannous fluoride dentifrice versus an arginine-containing dentifrice.

PURPOSE: To assess the anti-erosion effects of a 0.454% stannous fluoride dentifrice versus a marketed dentifrice in an in situ clinical study. METHODS: This was a double-blind, randomized and controlled, two-treatment, four-period crossover clinical study involving healthy adults. Each study period was 10 days. Subjects were randomized to one of two dentifrice products each period: an experimental 0.454% stannous fluoride dentifrice (1,100 ppm fluoride) or a marketed 1.5% arginine-containing dentifrice (Colgate Maximum Cavity Protection, 1,450 ppm fluoride). Subjects wore an intra-oral appliance fitted with two polished human enamel samples for 6 hours per day, swishing with the assigned dentifrice slurry twice a day in addition to sipping and swishing with 250 ml of orange juice for 10 minutes (in increments of 25 ml each minute) four times each day. Contact profilometry was used to measure surface loss of tooth enamel over the course of the study. Two measurements for each sample were taken at baseline and Day 10. RESULTS: 35 subjects were randomized to treatment and 31 completed the study (mean age = 40 years). At Day 10, enamel loss means were 0.128 µm for the stannous fluoride dentifrice and 1.377 µm for the arginine-containing dentifrice, respectively (P< 0.001). This represents 90.7% less enamel loss for the stannous fluoride dentifrice. Both products were well tolerated. CLINICAL SIGNIFICANCE: The 0.454% stannous fluoride dentifrice demonstrated significantly greater protection to human enamel against erosive acid challenges relative to the marketed 1.5% arginine-containing dentifrice in this in situ clinical study.

Comparative Antiplaque Effect of Two Antimicrobial Dentifrices: Laboratory and Clinical Evaluations.

OBJECTIVES: To compare the effect of a stannous fluoride dentifrice versus a triclosan-containing dentifrice on the reduction of plaque using in vitro and clinical models. METHODS: Both investigations evaluated a novel 0.454% stabilized stannous fluoride dentifrice (Crest® Pro-Health™ smooth formula) versus a sodium fluoride/triclosan positive control dentifrice (Colgate® Total®). The in vitro evaluation utilized the Plaque Glycolysis and Regrowth Model (PGRM), wherein the metabolic effects (acid production/glycolysis inhibition) of the dentifrices were assessed on plaque biofilms grown on glass rods after three days growth and a single dentifrice treatment. Treatments were evaluated via analysis of variance, Student's t-test. The clinical trial was a four-week, single-center, randomized and controlled, double-blind, parallel group study, where 120 adults were randomized to one of the two dentifrices for use at home according to manufacturer's instructions. Plaque was evaluated at baseline and Week 4 with the Rustogi Modified Navy Plaque Index (RMNPI). Statistical analyses were via analysis of covariance. RESULTS: In vitro PGRM: The stannous fluoride dentifrice provided 43.3% glycolysis inhibition compared to 27.5% for the triclosan control, and the pH decrease associated with acid production was significantly less for stannous fluoride (0.87) versus triclosan (1.11); p < 0.05. Clinical trial: One hundred eighteen (118) subjects completed the study with fully evaluable data. Both dentifrice groups demonstrated statistically significant (p < 0.0001) reductions in plaque at Week 4 compared with baseline, with the stannous fluoride dentifrice producing a significantly lower adjusted mean Week 4 plaque score (p < 0.0001) versus the triclosan positive control for whole mouth plaque (23.1% lower) and interproximal plaque (43.5% lower). Both dentifrices were well-tolerated. CONCLUSIONS: The stabilized stannous fluoride dentifrice provided statistically significant reductions in plaque glycolysis in vitro and plaque growth in vivo compared to the triclosan dentifrice. Results for both studies were consistent.

Assessment of the Effects of a Novel Stabilized Stannous Fluoride Dentifrice on Gingivitis in a Two-Month Positive-Controlled Clinical Study.

OBJECTIVES: The aim of this study was to compare the antibleeding/antigingivitis effectiveness of a newly formulated 0.454% stabilized stannous fluoride dentifrice and a marketed positive control triclosan-containing dentifrice in adults with mild-to-moderate gingivitis. METHODS: This single-center, two-month, randomized and controlled, double-blind, parallel group clinical trial involved adults with preexisting mild-to-moderate gingivitis. Baseline bleeding and gingivitis levels were assessed with the Gingival Bleeding Index (GBI) and Lobene Modified Gingival Index (MGI). Subjects were randomly assigned to either a new smooth formula 0.454% stabilized stannous fluoride test dentifrice (Crest® Pro-Health™) or a commercially available positive control 0.30% triclosan dentifrice (Colgate® Total®). Subjects brushed with their assigned dentifrice at home according to the manufacturer's instructions. At Month 2, subjects were re-evaluated for bleeding and gingivitis as at Baseline, with MGI and GBI evaluations. RESULTS: Of the 200 subjects randomized to treatment, 197 completed the study and had fully evaluable data. At Month 2, both the stannous fluoride and triclosan control dentifrices produced statistically significant reductions (p < 0.0001) in the mean number of bleeding sites, MGI, and GBI compared to Baseline. Use of this 0.454% stannous fluoride dentifrice resulted in 22% fewer bleeding sites versus the positive control triclosan dentifrice (p < 0.0001). Similarly, after two months of brushing, the stannous fluoride dentifrice group showed statistically significant lower mean MGI and GBI scores than subjects using the triclosan positive control dentifrice (p < 0.0001). Both dentifrices were well-tolerated. CONCLUSIONS: Subjects brushing with a newly formulated stannous fluoride dentifrice had statistically significantly fewer bleeding sites and less gingivitis than those using a positive control triclosan dentifrice after two months.

A Randomized Controlled Clinical Trial to Evaluate Extrinsic Stain Removal of a Whitening Dentifrice.

OBJECTIVES: To evaluate the extrinsic stain removal efficacy of a new whitening dentifrice containing sodium hexametaphosphate (SHMP) over a two-week period. METHODS: This study used a controlled and randomized, examiner-blind, single-center, two-treatment, parallel group design. Subjects with visible extrinsic dental stain on facial surfaces of their anterior teeth, and meeting all study criteria, were entered into the trial. The test group received the whitening dentifrice with sodium fluoride and SHMP and an ADA reference soft manual toothbrush. Subjects in the control group received a dental prophylaxis after the initial examination at Baseline and were instructed to use their usual oral hygiene products at home. Subjects returned at Day 3 and Week 2 for re-evaluation of extrinsic dental stain. Extrinsic stain was measured using the Interproximal Modified Lobene (IML) Stain Index; safety was assessed based on clinical examination. RESULTS: Fifty subjects (mean age 32.0 years) completed the study, with 25 in each group. Statistically significant reductions in composite stain for whole tooth, as well as interproximal, gingival, and body surfaces were observed for both groups at Day 3 and Week 2 (p < 0.0001) with no significant differences between the two groups (p > 0.3). At Day 3, median percent reductions in composite IML stain from Baseline were 98% for the prophylaxis group and 100% for the test dentifrice group. At Week 2, median percent reductions in composite IML stain were 100% compared to Baseline for both groups. No adverse events were reported for either group. CONCLUSIONS: The whitening dentifrice demonstrated a statistically significant reduction in IML stain after three days and two weeks of use relative to baseline. Stain reduction with the toothpaste was comparable to a dental prophylaxis.

A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data.

This 2-year trial evaluated the efficacy and tolerability of a monthly oral regimen of risedronate. Postmenopausal women with osteoporosis were randomly assigned to double-blind treatment with risedronate 75 mg on 2 consecutive days each month (2CDM) or 5 mg daily. The primary end point was the percentage change from baseline in lumbar spine bone mineral density (BMD) at 12 months. Secondary end points included the change in BMD of the lumbar spine and proximal femur and in bone turnover markers as well as the number of subjects with at least one new vertebral fracture over 24 months. Among 1,229 patients who were randomized and received at least one dose of risedronate, lumbar spine BMD was increased in both treatment groups: mean percentage change from baseline was 4.2 ± 0.19 and 4.3 ± 0.19 % in the 75 mg 2CDM and 5 mg daily groups, respectively, at month 24. The treatment difference was 0.17 (95 % confidence interval -0.35 to 0.68). There were no statistically significant differences between treatment groups on any secondary efficacy parameters. Both treatment regimens were well tolerated. Risedronate 75 mg 2CDM was noninferior in BMD efficacy and did not show a difference in tolerability compared to 5 mg daily after 24 months of treatment in women with postmenopausal osteoporosis. This monthly regimen may provide a more convenient dosing schedule to some patients with postmenopausal osteoporosis.

Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study.

A 2-year, randomized, double-blind, placebo-controlled study in men with osteoporosis demonstrated that treatment with risedronate 35mg once a week significantly decreased bone turnover markers (BTMs) and increased bone mineral density (BMD). This study was extended to include a 2-year, open-label extension to continue to assess the safety and efficacy of risedronate in men with osteoporosis. In the open-label extension, all patients received risedronate 35mg once a week, and 1000mg elemental calcium and 400 to 500IU vitamin D daily for up to 2 years. The safety of risedronate was evaluated based on adverse events, laboratory data, vital signs, and physical examination results. BMD, BTMs, and the incidence of new vertebral fractures were also assessed. A total of 218 (of 284) patients enrolled in the open-label extension. Risedronate continued to produce significant increases in lumbar spine BMD from baseline (7.87%) in the group of patients who took it for 4 years. Risedronate produced significant increases in lumbar spine BMD from baseline (6.27%) in the former placebo group who took it for 2 years during the open-label extension. Few new vertebral and clinical fractures occurred during the study. There were no significant differences in BTMs between the two groups at months 36 and 48. Incidences of any upper GI adverse events during the extension were low and similar in the two groups; however, the percent of moderate to severe events were higher (8% versus 2%) in the group that received placebo prior to the extension. Safety results continued to show that risedronate was well-tolerated in men with osteoporosis. Patients who received risedronate 35mg once a week for 2years in the open-label extension study showed similar safety and efficacy results compared with those who received risedronate treatment in the first 2 double-blind years of the study. Patients who received risedronate for 4 years in total showed similar safety and efficacy to that observed in women with postmenopausal osteoporosis treated with risedronate for 4 years. (ClinicalTrials.gov Identifier number: NCT00619957).

Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study.

Male osteoporosis is increasingly recognized as a major public health issue. This multinational, 2-yr, randomized, double-blind, placebo-controlled study was conducted to determine the efficacy and safety of 35 mg once-a-week risedronate in men with osteoporosis. Patients had to be men >or=30 yr old, with lumbar spine T-score

Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis.

INTRODUCTION: Risedronate has been shown to be effective in the treatment of postmenopausal osteoporosis when given orally in daily or weekly doses or on 2 consecutive days per month. This randomized, double-blind, multi-center study was designed to assess the efficacy and safety of a single 150 mg risedronate once-a-month oral dose compared with the 5 mg daily regimen. METHODS: Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg daily (n=642) or 150 mg once a month (followed by daily placebo) (n=650) in a double-blind fashion for 2 years. Study drug was taken on an empty stomach at least 30 min before breakfast. Bone mineral density, bone turnover markers, fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine bone mineral density after 1 year. RESULTS: 538 patients in the daily group (83.8%) and 556 patients in the once-a-month group (85.5%) completed 1 year. The mean percent change in lumbar spine bone mineral density was 3.4% (95% confidence interval, 3.03% to 3.82%) in the daily group and 3.5% (95% confidence interval, 3.15% to 3.93%) in the once-a-month group. The difference between groups was -0.1% (95% confidence interval, -0.51% to 0.27%). The once-a-month regimen was determined to be non-inferior to the daily regimen based on prospectively defined criteria. The mean percent changes in bone mineral density at sites in the hip (total proximal femur, femoral neck, femoral trochanter) were also similar in both dose groups, as were the changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the 2 treatment groups. Both regimens were well tolerated; the percent of patients who withdrew from treatment as a result of an adverse event was 9.5% in the daily group and 8.6% in the once-a-month group. CONCLUSIONS: Risedronate 150 mg once a month is similar in efficacy and safety to daily dosing and may provide an alternative for patients who prefer once-a-month oral dosing.

Site-specific prevalence and cell densities of selected microbes in the lower reproductive tract of menstruating tampon users.

OBJECTIVE: To assess differences in prevalence and cell densities of enterococci, Gram negative enterics (GNEs), yeast and Staphylococcus aureus among four genital sites and to examine whether the presence of organisms at one site affected the presence of organisms at other sites. METHODS: Swab samples from the perineum, below and above the hymen, and the posterior fornix obtained from 52 tampon users on menstrual cycle day 3 were analyzed for site-specific prevalence and cell densities of microorganisms. RESULTS: Enterococci and GNEs were the most prevalent study organisms at all sites and decreased in prevalence from the perineum to the posterior fornix. Cell densities similarly decreased from below the hymen to the posterior fornix. Yeast were detected at the hymen only; S. aureus frequency was similarly low at all sites. Yeast and S. aureus site-specific cell densities were similar. The above- and below-hymen sites were similar in prevalence and cell density of organisms. An above-chance association existed between the presence of any study organism below the hymen and above the hymen and was strongest for GNEs. CONCLUSIONS: The pattern of genital colonization with enterococci and GNEs reflects their likely gastrointestinal source. The absence of significant differences in the prevalence and cell densities of study microflora above and below the hymen combined with an above-chance association of the presence of microorganisms at these regions suggests that the regions above and below the hymen are not different with respect to the presence of the organisms evaluated in this study.