Important goals of clinical research include the development of study goals, 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/maxillofacial imaging, histomorphometry, examiner calibration, good clinical practice, ridge augmentation, soft/hard tissue grafting, sinus augmentation and periodontal regeneration protocols. This text is an essential reference guide for clinical researchers engaged in research in oral tissue regeneration.

Editors:

William Giannobile is the Najjar Endowed Professor of Dentistry and Biomedical Engineering at the School of Dentistry and College of Engineering at the University of Michigan in Ann Arbor. The past-president of the American Academy of Periodontology Foundation, he is currently the Editor-in-Chief of the Journal of Dental Research, the official journal of the International Association of Dental Research.

Niklaus P. Lang is Emeritus Professor of the University of Berne, Switzerland. He is also Honorary Professor at the Universities of Zurich, Hong Kong and University College, UK. Moreover he is the Editor-in-Chief of the Clinical Oral Implants Research journal.

Maurizio S. Tonetti is Executive Director of the European Research Group on periodontology. He owns a private practice limited to Periodontology and Implant Dentistry, in Genova, Italy, and is also Editor-in-Chief of the Journal of Clinical Periodontology.


Contents:

Part I General Aspects in Clinical Research

Chapter 01 Research Designs and Hierarchies of Evidence - Ian Needleman
Chapter 02 Regulatory and Good Clinical Practice Aspects in Clinical Practice - Gudrun Denke
Chapter 03 Ethical Aspects in Clinical Research - Klaus Peter Rippe
Chapter 04 Development of a Clinical Research Protocol - Maurizio S. Tonetti
Chapter 05 Management of a Clinical Study - Jeanie Suvan
Chapter 06 Authorship and Publication of Clinical Research Findings - William V. Giannobile

Part II Tools for Preparation, Conduction and Analysis of a Clinical Study

Chapter 07 Endpoints in Oral and Maxillofacial Regeneration Clinical Trials - Mariano Sanz, Fabio Vignoletti
Chapter 08 Patient Reported Outcome Measures (PROMs) for Implant Dentistry and Oral Tissue Regeneration - Colman McGrath
Chapter 09 Examiner Standardization and Calibration for Oral and Periodontal Regenerative Studies - Hatice Hasturk, MaryAnn Cugini
Chapter 10 Statistical Analysis for Clinical Studies - Jürg Hüsler
Chapter 11 Analytical Methods - Dieter D. Bosshardt, Erika Benavides, Hector F. Rios, Alpdogan Kantarci, Niklaus P. Lang, Jie Han, Christina Sim, David Schneider, Sven Mühlemann, Goran Benic, Irena Sailer

Part III Study Protocols for Specific Indications

Chapter 12 Clinical Research Protocols for Indications in Dental Regeneration - Pierpaolo Cortellini, Suzanne Mason, Feng Wang, Darnell Kaigler, Nikos Donos, Nikos Mardas, Isabella Rocchietta, David Nisand, Massimo Simion, Gustavo Avila-Ortiz, Pablo Galindo-Moreno, Giovanni E. Salvi, Dieter D. Bosshardt, Niklaus P. Lang, Lisa J.A. Heitz-Mayfield, Michael K. McGuire, Anton Sculean, Sofia Aroca, Daniel S. Thoma, Ronald E. Jung

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