The Experts below are selected from a list of 135 Experts worldwide ranked by ideXlab platform
Christine Parmentier - One of the best experts on this subject based on the ideXlab platform.
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Dental Device associated problems an analysis of fda postmarket surveillance data
Journal of the American Dental Association, 2001Co-Authors: Janie Fuller, Christine ParmentierAbstract:ABSTRACT Background The authors provide an analysis of Dental Device adverse event reports collected through the U.S. Food and Drug Administration's, or FDA's, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999. Methods This study includes an analysis of the total number of Dental Device adverse events reported during the study period and uses descriptive statistics to depict reporters' occupations, types of adverse events (deaths, injuries, malfunctions), Device categories, Device problems and patient problems. Results A total of 272,241 Device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved Dental Devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 Device malfunctions (34.8 percent) were reported. The most commonly reported Dental Devices were endosseous implants, which represented more than 90 percent of all Dental Device reports. Most reports (84.1 percent) provided the reporter's occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by Dental assistant (4.2 percent). Conclusions Dentists and Dental staff members are a vital link in the FDA's adverse event reporting system and are encouraged to report Device problems to the FDA MedWatch program.
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Dental Device–associated problems: An analysis of FDA postmarket surveillance data
Journal of the American Dental Association, 2001Co-Authors: Janie Fuller, Christine ParmentierAbstract:ABSTRACT Background The authors provide an analysis of Dental Device adverse event reports collected through the U.S. Food and Drug Administration's, or FDA's, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999. Methods This study includes an analysis of the total number of Dental Device adverse events reported during the study period and uses descriptive statistics to depict reporters' occupations, types of adverse events (deaths, injuries, malfunctions), Device categories, Device problems and patient problems. Results A total of 272,241 Device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved Dental Devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 Device malfunctions (34.8 percent) were reported. The most commonly reported Dental Devices were endosseous implants, which represented more than 90 percent of all Dental Device reports. Most reports (84.1 percent) provided the reporter's occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by Dental assistant (4.2 percent). Conclusions Dentists and Dental staff members are a vital link in the FDA's adverse event reporting system and are encouraged to report Device problems to the FDA MedWatch program.
Janie Fuller - One of the best experts on this subject based on the ideXlab platform.
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Dental Device associated problems an analysis of fda postmarket surveillance data
Journal of the American Dental Association, 2001Co-Authors: Janie Fuller, Christine ParmentierAbstract:ABSTRACT Background The authors provide an analysis of Dental Device adverse event reports collected through the U.S. Food and Drug Administration's, or FDA's, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999. Methods This study includes an analysis of the total number of Dental Device adverse events reported during the study period and uses descriptive statistics to depict reporters' occupations, types of adverse events (deaths, injuries, malfunctions), Device categories, Device problems and patient problems. Results A total of 272,241 Device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved Dental Devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 Device malfunctions (34.8 percent) were reported. The most commonly reported Dental Devices were endosseous implants, which represented more than 90 percent of all Dental Device reports. Most reports (84.1 percent) provided the reporter's occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by Dental assistant (4.2 percent). Conclusions Dentists and Dental staff members are a vital link in the FDA's adverse event reporting system and are encouraged to report Device problems to the FDA MedWatch program.
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Dental Device–associated problems: An analysis of FDA postmarket surveillance data
Journal of the American Dental Association, 2001Co-Authors: Janie Fuller, Christine ParmentierAbstract:ABSTRACT Background The authors provide an analysis of Dental Device adverse event reports collected through the U.S. Food and Drug Administration's, or FDA's, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999. Methods This study includes an analysis of the total number of Dental Device adverse events reported during the study period and uses descriptive statistics to depict reporters' occupations, types of adverse events (deaths, injuries, malfunctions), Device categories, Device problems and patient problems. Results A total of 272,241 Device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved Dental Devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 Device malfunctions (34.8 percent) were reported. The most commonly reported Dental Devices were endosseous implants, which represented more than 90 percent of all Dental Device reports. Most reports (84.1 percent) provided the reporter's occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by Dental assistant (4.2 percent). Conclusions Dentists and Dental staff members are a vital link in the FDA's adverse event reporting system and are encouraged to report Device problems to the FDA MedWatch program.
Nir Peled - One of the best experts on this subject based on the ideXlab platform.
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Short and long-term usage of a Dental Device in sleep apnea syndrome.
The Laryngoscope, 2009Co-Authors: Eli Peled, Naama Yoffe, Israel Blumenfeld, Nir PeledAbstract:Objective: To assess the efficacy, the compliance, and the complications of the anterior mandibular positioning (AMP) Device in obstructive sleep apnea syndrome (OSA) patients. Material & Methods: Polysomnographic sleep studies were performed on 38 patients before and two weeks (± 3 days) after continuous use of the AMP Device. Twenty patients also underwent polysomnographic follow-up recordings after 1 year. Results: The mean apnea-hypopnea index (AHI) before treatment was 35.6 ± 17.7 and decreased significantly to 22.7 ± 15.8 after 2 weeks of treatment (p = 0.01). The mean AHI after 1 year of usage was 25.3 ± 12.9, differing significantly from the pretreatment AHI (p = 0.01). Seventy-one percent of patients used the Device for 18.4 months (range 12–27). One-year clinical evaluation showed preserved Dental status, preserved action of the masticatory muscles, and preserved function of the temporo-mandibular joint (TMJ). Eleven (29%) of the patients did not use the AMP Device because of TMJ pain and/or unsatisfying results. Conclusions: The AMP Device is well tolerated in 76% of patient. When tolerated, its compliance and efficiency are preserved across the year without long-term oral and jaw dysfunctions. Laryngoscope, 119:585–588, 200
Susan Redline - One of the best experts on this subject based on the ideXlab platform.
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objective adherence to Dental Device versus positive airway pressure treatment in adults with obstructive sleep apnea
Journal of Sleep Research, 2020Co-Authors: Dawei Xie, Kara S Griffin, Bethany Staley, Ying Wang, Deborah A Nichols, Ruth M Benca, Allan I Pack, Susan RedlineAbstract:Although mandibular advancement Device (MAD) treatment of adults with obstructive sleep apnea (OSA) is generally less efficacious than positive airway pressure (PAP), the two treatments are associated, with similar clinical outcomes. As a sub-analysis of a randomized trial comparing the effect of MAD versus PAP on blood pressure, this study compared objectively measured adherence to MAD versus PAP treatment in adults with OSA. Adults with OSA (age 54.1 ± 11.2 [standard deviation] years, 71.1% male, apnea-hypopnea index 31.6 ± 22.7 events/h) were randomized to MAD (n = 89) or PAP (n = 91) treatment for 3-6 months. Objective adherence was assessed with a thermal sensor embedded in the MAD and a pressure sensor in the PAP unit. In a per protocol analysis, no difference was observed in average daily hours of use over all days in participants on MAD (n = 35, 4.4 ± 2.9 h) versus PAP (n = 51, 4.7 ± 1.6 h, p = .597) treatment when days with missing adherence data were included as no use. MAD was used on a lower percentage of days (62.5 ± 36.4% versus 79.9 ± 19.8%, p = .047), but with greater average daily hours of use on days used (6.4 ± 1.9 h versus 5.7 ± 1.2 h, p = .013). Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment. Similar results were obtained when excluding days with missing adherence data. In conclusion, no significant difference was observed in objectively measured average daily hours of MAD and PAP adherence in adults with OSA, despite differences in the patterns of use. MAD adherence in the first week predicted long-term use.
Eli Peled - One of the best experts on this subject based on the ideXlab platform.
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Short and long-term usage of a Dental Device in sleep apnea syndrome.
The Laryngoscope, 2009Co-Authors: Eli Peled, Naama Yoffe, Israel Blumenfeld, Nir PeledAbstract:Objective: To assess the efficacy, the compliance, and the complications of the anterior mandibular positioning (AMP) Device in obstructive sleep apnea syndrome (OSA) patients. Material & Methods: Polysomnographic sleep studies were performed on 38 patients before and two weeks (± 3 days) after continuous use of the AMP Device. Twenty patients also underwent polysomnographic follow-up recordings after 1 year. Results: The mean apnea-hypopnea index (AHI) before treatment was 35.6 ± 17.7 and decreased significantly to 22.7 ± 15.8 after 2 weeks of treatment (p = 0.01). The mean AHI after 1 year of usage was 25.3 ± 12.9, differing significantly from the pretreatment AHI (p = 0.01). Seventy-one percent of patients used the Device for 18.4 months (range 12–27). One-year clinical evaluation showed preserved Dental status, preserved action of the masticatory muscles, and preserved function of the temporo-mandibular joint (TMJ). Eleven (29%) of the patients did not use the AMP Device because of TMJ pain and/or unsatisfying results. Conclusions: The AMP Device is well tolerated in 76% of patient. When tolerated, its compliance and efficiency are preserved across the year without long-term oral and jaw dysfunctions. Laryngoscope, 119:585–588, 200