LEADER 05390nam 2200721Ia 450 001 9910957200903321 005 20200520144314.0 010 $a9786612491542 010 $a9781282491540 010 $a1282491547 010 $a9780813820552 010 $a0813820553 035 $a(CKB)2520000000007927 035 $a(EBL)484818 035 $a(OCoLC)593240077 035 $a(SSID)ssj0000335889 035 $a(PQKBManifestationID)11929245 035 $a(PQKBTitleCode)TC0000335889 035 $a(PQKBWorkID)10278066 035 $a(PQKB)10942881 035 $a(MiAaPQ)EBC484818 035 $a(Au-PeEL)EBL484818 035 $a(CaPaEBR)ebr10361325 035 $a(CaONFJC)MIL249154 035 $a(Perlego)2755024 035 $a(EXLCZ)992520000000007927 100 $a20091007d2010 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aClinical research in oral health /$f[edited by] William V. Giannobile, Brian A. Burt, Robert J. Genco 205 $a1st ed. 210 $aAmes, IA $cWiley-Blackwell$d2010 215 $a1 online resource (394 p.) 300 $aDescription based upon print version of record. 311 08$a9780813815299 311 08$a0813815290 320 $aIncludes bibliographical references and index. 327 $aClinical 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 regulations 327 $a2.5 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 research 327 $a3.5 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 overview 327 $a5.2 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? 327 $a7.3 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 angulation 327 $a9.6 Patterns of examiner bias 330 $aClinical 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. 606 $aDentistry$xResearch 606 $aTeeth$xCare and hygiene$xResearch 615 0$aDentistry$xResearch. 615 0$aTeeth$xCare and hygiene$xResearch. 676 $a617.522 676 $a617.60072 701 $aGiannobile$b William V$01805692 701 $aGenco$b Robert J$01805693 701 $aBurt$b Brian A$01805694 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910957200903321 996 $aClinical research in oral health$94354427 997 $aUNINA