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OSTEOPOROSIS AND BONE AUGMENTATION/IMPLANT OUTCOMES: AN OBSERVATIONAL STUDY

Martin A Freilich
University Of Connecticut Sch Of Med/dnt, Office Of Research & Sponsored Programs, Farmington, Ct 06030

Grant 5R01DE017873-04 from National Institute Of Dental & Craniofacial Research

Abstract: Osteoporosis is a major public health issue in our aging population, affecting 44 million Americans. Evidence in the literature suggests that bone disorders such as osteoporosis, may compromise bone augmentation procedure outcomes. It is important, therefore, to better understand the relationship between this disorder and bone augmentation/dental implantation. The objective of this descriptive "best clinical practice" based study is to collect descriptive data estimating alveolar bone augmentation/implant placement success in postmenopausal women with bone mineral density (BMD) ranging from normal to osteoporotic. This is a critical first step in understanding this potentially important relationship. These data are needed to support the future development of bone biology founded hypotheses that will investigate potential associations of specific measures of bone health, including history of osteoporosis, with the successful integration of new bone from bone augmentation procedures. Our multidisciplinary group possesses expertise in epidemiology, behavioral science, radiography, implant surgery, prosthodontics, endocrinology/bone biology and clinical treatment of osteoporosis. We plan to accomplish the objectives of this application by pursuing two specific aims 1) To generate a descriptive estimate of the two-year success rate of bone augmentation followed by dental implant placement in postmenopausal women with normal to osteoporotic bone density; and 2) To explore potential associations between bone health parameters (e.g., BMD, biochemical markers of bone turnover, fracture history and vitamin D levels) and implant failure. To satisfy both aims, 120 subjects will receive bone augmentation, implant placement and prosthetic treatment based upon their specific presenting clinical situation, as guided by a specific set of criteria that will be part of the study protocol. Implant survival will be the primary outcome measure of success. However, success will be secondarily assessed by other relevant clinical outcomes, clinical efficiency, as well as patient satisfaction, pain and quality of life. Descriptive analyses will also explore potential predictive associations between bone health parameters and bone augmentation/implant success, both individually and in conjunction with one another. Data from this study will provide information about differential implant success rates for women possessing a spectrum of bone mineral density. Our long-range goal is to identify the most important predictors of bone augmentation/implant placement success among patients with compromised bone health and/or unfavorable local alveolar architecture. We then wish to develop and test the best methods by which to provide these therapies, including the application of techniques with which to guide new alveolar bone formation at deficient osseous sites. This application represents an important step in this ongoing research initiative

Keywords: Address; Affect; Alveolar; Alveolar ridge; American; Animal Model; Animal Models and Related Studies; Architecture; Au element; Behavioral Sciences; Biochemical Markers; Biology; Bone; Bone Density; Bone Development; Bone Diseases; Bone Formation; Bone Mineral Density; Bone Resorption; Bone and Bones; Bones and Bone Tissue; Client satisfaction; Clinical; Clinical Research; Clinical Study; Clinical Treatment; Conventional X-Ray; Coxa; DXA; Data; Dental; Dental Implantation; Dental Implants; Dental Prosthesis Implantation; Development; Diagnosis; Diagnostic Radiology; Diagnostic radiologic examination; Disease; Disorder; Dual-Energy X-Ray Absorptiometry; Endocrinology; Engineering / Architecture; Epidemiology; FLR; Failure (biologic function); Foundations; Fracture; Funding Mechanisms; Future; Goals; Gold; Height; Hip; Hip region structure; History; Image; Implant; Implantation procedure; Incidence; Investigation; Investigators; Jaw; Letters; Link; Literature; Markers, Biochemical; Measurement; Measures; Medical Imaging, X-Ray; Metabolism and Endocrinology; Methods; Methods and Techniques; Methods, Other; Minerals; Normal Range; Normal Values; Observational Study; Operation; Operative Procedures; Operative Surgical Procedures; Oral; Osteoclastic Bone Loss; Osteogenesis; Osteoporosis; Outcome; Outcome Measure; Pain; Painful; Patient Satisfaction; Patients; Post-Menopause; Post-menopausal Period; Postmenopausal Period; Postmenopause; Procedures; Programs (PT); Programs [Publication Type]; Prosthesis; Prosthetic device; Prosthetics; Prosthodontic; Prosthodontic specialty; Prosthodontics; Protocol; Protocols documentation; Public Health; QOL; Quality of life; Radiography; Radiology, Diagnostic X-Ray; Recording of previous events; Reporting; Research; Research Personnel; Researchers; Retrospective Studies; Review Literature; Risk; Risk Factors; Roentgenography; Role; Science of Statistics; Screening procedure; Site; Spinal Column; Spine; Statistics; Structure; Study models; Surgical; Surgical Interventions; Surgical Procedure; Techniques; Technology; Testing; Time; Tooth Loss; VIT D; Vertebral column; Vitamin D; Vitamins; Width; Woman; Work; X-Ray Absorptiometry, Dual-Energy; X-Ray Imaging; X-Ray, Diagnostic; aging population; alveolar bone; alveolar bone of maxilla; alveolar process of maxilla; alveolar supporting bone; backbone; base; bone; bone disorder; bone fracture; bone health; bone mass; bone metabolism; bone strength; bone turnover; clinical practice; clinical relevance; clinically relevant; density; design; designing; disease/disorder; experience; failure; imaging; implant placement; implant procedure; insight; model organism; multidisciplinary; novel; post-menopausal; postmenopausal; primary outcome; programs; public health medicine (field); reconstruction; repair; repaired; response; screening; screenings; skeletal disorder; social role; socket wall; statistics; success; surgery; tool; trial regimen; trial treatment

Project start date: 2006-09-15

Project end date: 2011-06-30

Budget start date: 1-JUL-2009

Budget end date: 30-JUN-2010

PFA/PA: RFA-DE-06-007

5R01DE017873-04 (2009): $434758


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OSTEOPOROSIS AND BONE AUGMENTATION/IMPLANT OUTCOMES: AN OBSERVATIONAL STUDY

Martin A Freilich
University Of Connecticut Sch Of Med/dnt, Office Of Research & Sponsored Programs, Farmington, Ct 06030

Grant 5R01DE017873-05 from National Institute Of Dental & Craniofacial Research

Abstract: Osteoporosis is a major public health issue in our aging population, affecting 44 million Americans. Evidence in the literature suggests that bone disorders such as osteoporosis, may compromise bone augmentation procedure outcomes. It is important, therefore, to better understand the relationship between this disorder and bone augmentation/dental implantation. The objective of this descriptive "best clinical practice" based study is to collect descriptive data estimating alveolar bone augmentation/implant placement success in postmenopausal women with bone mineral density (BMD) ranging from normal to osteoporotic. This is a critical first step in understanding this potentially important relationship. These data are needed to support the future development of bone biology founded hypotheses that will investigate potential associations of specific measures of bone health, including history of osteoporosis, with the successful integration of new bone from bone augmentation procedures. Our multidisciplinary group possesses expertise in epidemiology, behavioral science, radiography, implant surgery, prosthodontics, endocrinology/bone biology and clinical treatment of osteoporosis. We plan to accomplish the objectives of this application by pursuing two specific aims 1) To generate a descriptive estimate of the two-year success rate of bone augmentation followed by dental implant placement in postmenopausal women with normal to osteoporotic bone density; and 2) To explore potential associations between bone health parameters (e.g., BMD, biochemical markers of bone turnover, fracture history and vitamin D levels) and implant failure. To satisfy both aims, 120 subjects will receive bone augmentation, implant placement and prosthetic treatment based upon their specific presenting clinical situation, as guided by a specific set of criteria that will be part of the study protocol. Implant survival will be the primary outcome measure of success. However, success will be secondarily assessed by other relevant clinical outcomes, clinical efficiency, as well as patient satisfaction, pain and quality of life. Descriptive analyses will also explore potential predictive associations between bone health parameters and bone augmentation/implant success, both individually and in conjunction with one another. Data from this study will provide information about differential implant success rates for women possessing a spectrum of bone mineral density. Our long-range goal is to identify the most important predictors of bone augmentation/implant placement success among patients with compromised bone health and/or unfavorable local alveolar architecture. We then wish to develop and test the best methods by which to provide these therapies, including the application of techniques with which to guide new alveolar bone formation at deficient osseous sites. This application represents an important step in this ongoing research initiative

Keywords: Address; Affect; Alveolar; Alveolar ridge; American; Animal Model; Animal Models and Related Studies; Architecture; Au element; Behavioral Sciences; Biochemical Markers; Biology; Bone; Bone Density; Bone Development; Bone Diseases; Bone Formation; Bone Mineral Density; Bone Resorption; Bone and Bones; Bones and Bone Tissue; Client satisfaction; Clinical; Clinical Research; Clinical Study; Clinical Treatment; Conventional X-Ray; Coxa; DXA; Data; Dental; Dental Implantation; Dental Implants; Dental Prosthesis Implantation; Development; Diagnosis; Diagnostic Radiology; Diagnostic radiologic examination; Disease; Disorder; Dual-Energy X-Ray Absorptiometry; Endocrinology; Engineering / Architecture; Epidemiology; FLR; Failure (biologic function); Foundations; Fracture; Funding Mechanisms; Future; Goals; Gold; Height; Hip; Hip region structure; History; Image; Implant; Implantation procedure; Incidence; Investigation; Investigators; Jaw; Letters; Link; Literature; Measurement; Measures; Medical Imaging, X-Ray; Metabolism and Endocrinology; Methods; Methods and Techniques; Methods, Other; Minerals; Normal Range; Normal Values; Observational Study; Operation; Operative Procedures; Operative Surgical Procedures; Oral; Osteoclastic Bone Loss; Osteogenesis; Osteoporosis; Outcome; Outcome Measure; Pain; Painful; Patient Satisfaction; Patients; Post-Menopause; Post-menopausal Period; Postmenopausal Period; Postmenopause; Procedures; Programs (PT); Programs [Publication Type]; Prosthesis; Prosthetic device; Prosthetics; Prosthodontic; Prosthodontic specialty; Prosthodontics; Protocol; Protocols documentation; Public Health; QOL; Quality of life; Radiography; Radiology, Diagnostic X-Ray; Recording of previous events; Reporting; Research; Research Personnel; Researchers; Retrospective Studies; Review Literature; Risk; Risk Factors; Roentgenography; Role; Science of Statistics; Screening procedure; Site; Spinal Column; Spine; Statistics; Structure; Study models; Surgical; Surgical Interventions; Surgical Procedure; Techniques; Technology; Testing; Time; Tooth Loss; VIT D; Vertebral column; Vitamin D; Vitamins; Width; Woman; Work; X-Ray Absorptiometry, Dual-Energy; X-Ray Imaging; X-Ray, Diagnostic; aging population; alveolar bone; alveolar bone of maxilla; alveolar process of maxilla; alveolar supporting bone; backbone; base; bone; bone disorder; bone fracture; bone health; bone mass; bone metabolism; bone strength; bone turnover; clinical practice; clinical relevance; clinically relevant; density; design; designing; disease/disorder; experience; failure; imaging; implant placement; implant procedure; insight; model organism; multidisciplinary; novel; post-menopausal; postmenopausal; primary outcome; programs; public health medicine (field); reconstruction; repair; repaired; response; screening; screenings; skeletal disorder; social role; socket wall; statistics; success; surgery; tool; trial regimen; trial treatment

Project start date: 2006-09-15

Project end date: 2011-06-30

Budget start date: 1-JUL-2010

Budget end date: 30-JUN-2011

PFA/PA: RFA-DE-06-007

5R01DE017873-05 (2010): $428660


5R01DE017873-03 (2008): $599520

5R01DE017873-02 (2007): $537235


Grants awarded to Martin A Freilich

Evaluation Of Fiber Biomaterials For Oral Implantology

Martin A Freilich
Reconstructive Sciencesuniversity Of Connecticut Sch Of Med/dnt
263 Farmington Avenue
farmington, Ct 060302806

Grant 1K23DE014187-01 from National Institute Of Dental & Craniofacial Research IRG: DSR

Abstract: This application for a K23 award is based upon this candidate´s tong-term goal to design and conduct clinical research and develop new dental biomaterials for clinical use. The candidate is board qualified in two clinical dental specialties, Prosthodontics and Periodontics. As a resident and faculty member, he has had opportunities to work with knowledgeable researchers who have guided his efforts in patient-based research. The candidate has developed a good understanding of scientific method and a solid foundation of skills, but seeks to further his research skills to gain independence and more effectively collaborate with biomaterials researchers and biostatisticians. A mentored training program which includes specific areas of didactic training in areas such as clinical research methodology, data management, biostatistics and polymer composite science will allow the candidate to accomplish these goals. The focus of this candidate´s research in recent years has been fiber-reinforced composite (FRC) research. The candidate has been involved in developing FRC materials, devising techniques for their use in making dental prostheses and testing these materials and techniques in the laboratory and the clinic. This proposal is designed to provide a clinics test for FRC prostheses used for implant dentistry. Glass FRC materials have been developed which have the potential to make an esthetic dental implant prosthesis substructure without the potential for corrosion and toxicity which may be seen with commonly used metal alloys. Laboratory and clinical research evaluating FRC prostheses used to restore and replace teeth has shown that these materials exhibit excellent mechanical properties and can form a chemical bond to polymer-based veneer materials. Two different designs of FRC implant prostheses have recently been developed 1) Screw-retained, retrievable prostheses and 2) Luted, non-retrievable prostheses. There is an important need for these two designs to be tested to determine if either is clinically superior. The candidate for this K23 award proposes to make an intra subject comparison between these two types of FRC partial implant prosthesis. The primary comparison between these prosthesis designs will be the incidence of Outcomes Requiring Intervention (failure of prosthesis or non-failures requiring intervention) observed over three years of recall examination

Keywords: biomaterial development /preparation, biomaterial evaluation, composite resin, dental implant, dental material, dental prosthesis, patient oriented research clinical trial, human therapy evaluation, oral facial restoration, oral facial restoration material, outcomes research, polymer dental radiography, human subject, medical implant science, statistics /biometry

Project start date: 2001-07-15

Project end date: 2006-05-31

1K23DE014187-01 (2001): $122865


5K23DE014187-05 (2005): $123188

5K23DE014187-04 (2004): $123094

5K23DE014187-03 (2003): $122902

Osteoporosis And Bone Augmentation/Implant Outcomes: An Observational Study

Martin A Freilich
University Of Connecticut Sch Of Med/dnt 263 Farmington Avenue Farmington, Ct 060302806

Grant 1R01DE017873-01 from National Institute Of Dental And Craniofacial Research IRG: ZDE1

Abstract: Osteoporosis is a major public health issue in our aging population, affecting 44 million Americans. Evidence in the literature suggests that bone disorders such as osteoporosis, may compromise bone augmentation procedure outcomes. It is important, therefore, to better understand the relationship between this disorder and bone augmentation/dental implantation. The objective of this descriptive "best clinical practice" based study is to collect descriptive data estimating alveolar bone augmentation/implant placement success in postmenopausal women with bone mineral density (BMD) ranging from normal to osteoporotic. This is a critical first step in understanding this potentially important relationship. These data are needed to support the future development of bone biology founded hypotheses that will investigate potential associations of specific measures of bone health, including history of osteoporosis, with the successful integration of new bone from bone augmentation procedures. Our multidisciplinary group possesses expertise in epidemiology, behavioral science, radiography, implant surgery, prosthodontics, endocrinology/bone biology and clinical treatment of osteoporosis. We plan to accomplish the objectives of this application by pursuing two specific aims 1) To generate a descriptive estimate of the two-year success rate of bone augmentation followed by dental implant placement in postmenopausal women with normal to osteoporotic bone density; and 2) To explore potential associations between bone health parameters (e.g., BMD, biochemical markers of bone turnover, fracture history and vitamin D levels) and implant failure. To satisfy both aims, 120 subjects will receive bone augmentation, implant placement and prosthetic treatment based upon their specific presenting clinical situation, as guided by a specific set of criteria that will be part of the study protocol. Implant survival will be the primary outcome measure of success. However, success will be secondarily assessed by other relevant clinical outcomes, clinical efficiency, as well as patient satisfaction, pain and quality of life. Descriptive analyses will also explore potential predictive associations between bone health parameters and bone augmentation/implant success, both individually and in conjunction with one another. Data from this study will provide information about differential implant success rates for women possessing a spectrum of bone mineral density. Our long-range goal is to identify the most important predictors of bone augmentation/implant placement success among patients with compromised bone health and/or unfavorable local alveolar architecture. We then wish to develop and test the best methods by which to provide these therapies, including the application of techniques with which to guide new alveolar bone formation at deficient osseous sites. This application represents an important step in this ongoing research initiative.

Keywords: bone, implant, osteoporosis, health, success, clinical research

Project start date: 2006-09-15

Project end date: 2011-06-30

1R01DE017873-01 (2006): $562303