Brush head wear, subject-perceived and laboratory cleaning performance of two oscillating-rotating electric toothbrush heads over 3 months.

PURPOSE: To evaluate the progression of wear and the effect of wear on subject-perceived and laboratory cleaning efficacy of two oscillating-rotating electric brush heads, Oral-B Precision Clean (PC) and a store brand Easyflex (SB) brush head, after 4, 6, 8 and 13 weeks of use. METHODS: This research consisted of three phases: (1) Subject questionnaires--A crossover, single-blinded study was conducted among healthy adults who were regular users of Oral-B oscillating-rotating electric toothbrushes. Subjects were recruited from a general population and randomized based on age and gender into one of four cohorts reflecting the time period of use for each product: 4, 6, 8 or 13 weeks. After brushing with their first product (either PC or SB) for the designated period of time, subjects completed a questionnaire evaluating the brush head on 17 attributes related to perceived cleaning performance, brush head condition (i.e., durability) and brush head feel (i.e., gentleness). Subjects then used the second test product for the same period of time and completed the same questionnaire. (2) Wear index investigation--At the end of each time period, subjects' worn brush head pairs were evaluated by an independent, blinded investigator to determine the wear index score. (3) Robot testing--To analyze the laboratory cleaning efficacy of worn refills in the laboratory, a representative sample of 12 subject brush head pairs for each of the four cohorts were evaluated (96 brush heads in total). To analyze the laboratory cleaning efficacy for PC at Week 13 with SB at Week 4, a separate set of 20 subjects (40 brush heads in total) were evaluated. A robot was used to brush standard typodonts (Frasaco A3) covered with plaque substitute with the worn brush head for 2 minutes under standardized, controlled conditions simulating human brushing behavior. A 3D laser scan system was used to measure the area still covered with plaque substitute at different dental sites. RESULTS: Subject questionnaire--267 subjects completed study questionnaires. Statistically significant superior ratings (P < 0.05) were obtained with the PC brush head compared to the SB brush head for virtually all attributes at all four time periods (16/17 attributes for Weeks 4, 6 and 8 and 17/17 at Week 13). Highly significant advantages (P < 0.0001) were seen for 'overall rating', 'overall cleaning' and 'ready to replace brush head' attributes. Wear Index-- A total of 486 brush head samples (243 pairs) were analyzed for wear. At all four time periods, PC brush heads had a statistically significantly lower (P < 0.0005) mean wear index than SB brush heads. Robot Test--136 brush heads were analyzed using a laboratory (robot) test to investigate cleaning efficacy. Directionally higher laboratory cleaning for PC versus SB was observed for all dental sites (35/35) for all time periods. Comparing PC at Week 13 with SB at Week 4 showed statistically significant differences (P < 0.05) in favor of PC for the majority of dental sites and time periods (23/35).

Testosterone for low libido in postmenopausal women not taking estrogen.

BACKGROUND: The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. METHODS: We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 microg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. RESULTS: At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001) but not in the group receiving 150 microg per day (1.2 episodes, P=0.11). As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 microg per day, P<0.001; 150 microg per day, P=0.04) and decreases in distress (300 microg per day, P<0.001; 150 microg per day, P=0.04). The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg of testosterone per day than in the placebo group (30.0% vs. 23.1%). Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. CONCLUSIONS: In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 microg of testosterone per day resulted in a modest but meaningful improvement in sexual function. The long-term effects of testosterone, including effects on the breast, remain uncertain. (ClinicalTrials.gov number, NCT00131495.)

Longitudinal progression of fracture prevalence through a population of postmenopausal women with osteoporosis.

AIM: To determine the longitudinal progression of fractures through a population of osteoporotic women with no existing vertebral fractures. METHODS: The probability of having one or more vertebral fractures in the next year given a current status of 0-13 existing vertebral fractures was estimated using data from control patients of an osteoporosis clinical trial program. Fracture probabilities were used to form a transition matrix that models the change in fracture state from one year to the next. A Markov model was used to show the distribution of fracture prevalence over time for a population of women with osteoporosis but, initially, with no existing vertebral fractures. RESULTS: An osteoporotic woman without existing vertebral fractures has a 7.7% chance (95% CI, 5.8% to 9.9%) of having a vertebral fracture within 1 year. After 5 years, 33% (95% CI, 25% to 41%) will have developed vertebral fractures, of which 11% (95% CI, 8% to 16%) will have > or =2 fractures. After 10 years, 55% (95% CI, 44% to 65%) will have developed vertebral fractures, of which 29% (95% CI, 22% 37%) will have > or =2 fractures. Each 1% absolute reduction in the annual first-fracture risk corresponds to an approximate 4% reduction in the 5-year fracture incidence. Therefore, reducing the risk of first fracture from 8% to 2% reduces the 5-year fracture incidence from approximately 34% to approximately 10%. CONCLUSIONS: Fracture prevalence rapidly increases over time in a population of osteoporotic women despite treatment with calcium and vitamin D supplements. Identifying and treating patients at risk of fracture, but who have not yet sustained a fracture, will substantially reduce the long-term burden of osteoporosis.