05309nam 2200673Ia 450 991045685130332120200520144314.01-282-49154-797866124915420-8138-2055-3(CKB)2520000000007927(EBL)484818(OCoLC)593240077(SSID)ssj0000335889(PQKBManifestationID)11929245(PQKBTitleCode)TC0000335889(PQKBWorkID)10278066(PQKB)10942881(MiAaPQ)EBC484818(Au-PeEL)EBL484818(CaPaEBR)ebr10361325(CaONFJC)MIL249154(EXLCZ)99252000000000792720091007d2010 uy 0engurcn|||||||||txtccrClinical research in oral health[electronic resource] /[edited by] William V. Giannobile, Brian A. Burt, Robert J. GencoAmes, IA Wiley-Blackwell20101 online resource (394 p.)Description based upon print version of record.0-8138-1529-0 Includes bibliographical references and index.Clinical Research in Oral Health; Contents; Contributors; Preface; Acknowledgments; 1 Clinical and translational research: implications in the promotion of oral health; 1.1 Challenges to the translation of clinical research to clinical practice; 1.2 Health technology assessments-identifying research priorities for oral health research; 1.3 Comparative-effectiveness research (CER); 2 Ethics in oral health research; 2.1 Introduction; 2.2 Ethical foundations; 2.3 Is it human subjects research?; 2.4 Federal regulations2.5 The Institutional and Ethical Review Board (IRB) for studies related to oral health 2.6 Informed consent; 2.7 Vulnerable populations; 2.8 Privacy, confidentiality, and HIPAA; 2.9 Oral health clinical research; 2.10 Conclusion; 3 Responsibilities of institutions and individuals in clinical research in the oral health sciences; 3.1 Governmental and institutional regulations, policies, and guidelines; 3.2 Educational responsibilities of institutions; 3.3 Financial responsibilities of institutions; 3.4 Responsibilities of investigators for FDA-regulated clinical research3.5 Intellectual property and clinical research 3.6 Authorship; 3.7 Scientific misconduct; 3.8 Conflicts of interest (COI); 3.9 Concluding remarks; 4 Regulatory process for the evaluation of dental drugs, devices, and biologics; 4.1 Mission of FDA; 4.2 FDA nomenclature; 4.3 Different pathways to approval; 4.4 Approved and non-approved dental-related products; 4.5 Regulatory processes in Canada, Europe, and other countries; 4.6 Summary; 5 Clinical and translational research grantsmanship: funding opportunities and obtaining research support; 5.1 Introduction and chapter overview5.2 Funding sources and opportunities 5.3 Grant-writing basics and developing research proposals; 5.4 Oversight of funded clinical research; 5.5 Conclusion; 6 Data management in oral health research; 6.1 Introduction; 6.2 Developing a data management plan; 6.3 Defining variables; 6.4 Preparing the database for data entry; 6.5 Using the database for data collection; 6.6 Using the data for analyses; 7 Hypothesis testing and avoiding false-positive conclusions; 7.1 Introduction; 7.2 How can hypothesis testing lead to an overabundance of false-positive leads?7.3 Quantifying the false-positive rates the theory; 7.4 Minimizing false-positive conclusions; registries, surrogates, randomization; 7.5 Conclusion; 8 Outcomes in oral health research; 8.1 Introduction; 8.2 Classification of outcomes; 8.3 Measurements of outcomes; 8.4 Dental and oral health outcomes in clinical research; 8.5 Outcomes and causal pathways; 8.6 Final comments; 9 Examiner training: standardization and calibration in periodontal studies; 9.1 Rationale; 9.2 Instruments; 9.3 Components of assessment; 9.4 Bleeding on probing; 9.5 Probing pressure and probe angulation9.6 Patterns of examiner biasClinical Research in Oral Health surveys the essentials of clinical research in oral health, anchoring these principles within the specific context of the oral health arena. Addressing research questions exclusively applicable to dentistry and oral health, the book thoroughly illustrates the principles and practice of oral health clinical research. Clinical Research in Oral Health also clarifies the framework of regulatory issues and presents emerging concepts in clinical translation, relating the research principles to clinical improvement.DentistryResearchTeethCare and hygieneResearchElectronic books.DentistryResearch.TeethCare and hygieneResearch.617.522617.60072Giannobile William V988592Genco Robert J988593Burt Brian A988594MiAaPQMiAaPQMiAaPQBOOK9910456851303321Clinical research in oral health2260526UNINA