Important aims of clinical research include the development of study objectives, research design methodology, and outcome measures. Proper articulation of these goals will lead to the determination of the outcomes of safety, efficacy and/or effectiveness of new dental drugs, biologics, devices, or procedures to improve patient care. This book guides researchers in creating protocols that lead to meaningful outcomes in oral and maxillofacial tissue regeneration. This text is written by a group of eminent investigators with expertise in all facets of clinical research from methodology to clinical protocols. Covered topics include oral and maxillofacial imaging, histomorphometry, examiner calibration, good clinical practice, ridge augmentation, soft and hard tissue grafting, sinus augmentation, and periodontal regeneration protocols. This is an essential reference guide for clinical researchers engaged in research in oral tissue regeneration.
Part I. General Aspects in Clinical Research
Chapter 01. Research Designs and Hierarchies of Evidence
Chapter 02. Regulatory and Good Clinical Practice Aspects in Clinical Practice
Chapter 03. Ethical Aspects in Clinical Research
Chapter 04. Development of a Clinical Research Protocol
Chapter 05. Management of a Clinical Study
Chapter 06. Authorship and Publication of Clinical Research Findings
Part II. Tools for Preparation, Conduction and Analysis of a Clinical Study
Chapter 07. Endpoints in Oral and Maxillofacial Regeneration Clinical Trials
Chapter 08. Patient Reported Outcome Measures (PROMs) for Implant Dentistry and Oral Tissue Regeneration
Chapter 09. Examiner Standardization and Calibration for Oral and Periodontal Regenerative Studies
Chapter 10. Statistical Analysis for Clinical Studies
Chapter 11. Analytical Methods
Part III. Study Protocols for Specific Indications
Chapter 12. Clinical Research Protocols for Indications in Dental Regeneration
Sofia Aroca • Gustavo Avila-Ortiz • Erika Benavides • Goran Benic • Dieter D. Bosshardt • Pierpaolo Cortellini • MaryAnn Cugini • Gudrun Denke • Nikos Donos • Pablo Galindo-Moreno • William V. Giannobile • Jie Han • Hatice Hasturk • Lisa J. A. Heitz-Mayfield • Jürg Hüsler • Ronald E. Jung • Darnell Kaigler • Alpdogan Kantarci • Niklaus P. Lang • Nikos Mardas • Suzanne Mason • Colman McGrath • Michael K. McGuire • Sven Mühlemann • Ian Needleman • David Nisand • Hector F. Rios • Klaus Peter Rippe • Isabella Rocchietta • Irena Sailer • Giovanni E. Salvi • Mariano Sanz • Anton Sculean • David Schneider • Christina Sim • Massimo Simion • Jeanie Suvan • Daniel S. Thoma • Maurizio S. Tonetti • Fabio Vignoletti • Feng Wang
William Giannobile, DDS, MS, DMSc, is dean of the Harvard School of Dental Medicine and a professor in the Department of Oral Medicine, Infection, and Immunity. He has produced over 300 manuscripts, textbook chapters, and patents focused on periodontology, regenerative medicine, and oral health research and is coeditor of nine books focused on clinical, translational research, periodontology, and regenerative medicine. He is a consultant to the US Food and Drug Administration for dental devices and has received numerous awards, including the American Dental Association Norton Ross Award for Excellence in Clinical Research. In addition to his administrative and teaching responsibilities, he practices periodontics and implant dentistry at the Harvard Dental Center.
Maurizio Tonetti graduated in Dentistry from Genoa University and received his masters in periodontology from Harvard University. He is a lecturer in Discipline Odontostomatologiche in Bern, Switzerland and currently a full lecturer and director of the Department of Periodontology and the School of Specialisation in Periodontology at Hong Kong University. He previously performed the same role at University College London and University of Connecticut Health Science Center. Dr Tonetti is also the executive director of the Research Group on Periodontology and Editor in Chief of the Journal of Clinical Periodontology. He is an active member and past president of SIdP and a member of the EFP steering committee. He is the author of more than 150 original scientific publications and has been a speaker at many important national and international conventions.