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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. Contents: Part I. General Aspects in Clinical Research - Research Designs and Hierarchies of Evidence
- Regulatory and Good Clinical Practice Aspects in Clinical Practice
- Ethical Aspects in Clinical Research
- Development of a Clinical Research Protocol
- Management of a Clinical Study
- Authorship and Publication of Clinical Research
Part II. Tools for Preparation, Conduction and Analysis of a Clinical Study - Endpoints in Oral and Maxillofacial Regeneration Clinical Trials
- Patient Reported Outcome Measures (PROMs) for Implant Dentistry and Oral Tissue Regeneration
- Examiner Standardization and Calibration for Oral and Periodontal Regenerative Studies
- Statistical Analysis for Clinical Studies
- Analytical Methods
Part III. Study Protocols for Specific Indications - Clinical Research Protocols for Indications in Dental Regeneration
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