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Record Nr. |
UNINA9910780831403321 |
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Titolo |
Clinical research in oral health [[electronic resource] /] / [edited by] William V. Giannobile, Brian A. Burt, Robert J. Genco |
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Pubbl/distr/stampa |
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Ames, IA, : Wiley-Blackwell, 2010 |
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ISBN |
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1-282-49154-7 |
9786612491542 |
0-8138-2055-3 |
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Descrizione fisica |
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1 online resource (394 p.) |
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Altri autori (Persone) |
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GiannobileWilliam V |
GencoRobert J |
BurtBrian A |
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Disciplina |
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Soggetti |
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Dentistry - Research |
Teeth - Care and hygiene - Research |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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 regulations |
2.5 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 |
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3.5 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 |
5.2 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 angulation |
9.6 Patterns of examiner bias |
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Sommario/riassunto |
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Clinical 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. |
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