Clinical Research Guidelines

Not only geared towards clinical researchers in an academic environment, but also towards those clinicians whose research has arisen from their practical experience, this volume by the editors William V.Giannobile, Niklaus P. Lang and Maurizio S. Tonetti pays particular attention to the development of study protocols, validated measurements and analytical methods. As in the Pre-clinical Research Guidelines, ethical and regulatory aspects are also addressed. The editors and contributors all have considerable experience in regenerative dentistry. Their recommendations are based on extensive research experience as well as a thorough analysis of the topic. For this reason, the Osteology Research Guidelines will likely be of great help to other researchers in the efficient planning and realization of their studies - which should further enhance the quality of the scientific data.

Part 1: General Aspects in Clinical Research

Part I is focusing on basic fundamental principles of clinical research design, regulatory practice, ethics, protocol design, trial management, authorship for publications, endpoints, patient-reported outcomes, examiner calibration, and biostatistics. The first ten chapters help serve as building blocks of information to assist the graduate student, developing researcher, and even the more experienced clinical researcher in the understanding of contemporary guidelines of clinical research conduct.

Part 2: Analytical Methods

Part II of the book includes sections on analytical methods (histology, imaging, biomarker assessment, soft and hard tissue imaging) that have direct implications for the consideration of quality endpoints and outcomes that may be measured in clinical research studies of the oral and maxillofacial complex.

Part 3: Study Protocols

Part III is the culmination of tremendous experience of clinical researchers with the presentation of clinical research protocols for oral, craniofacial, and dental tissue regeneration. These protocols include periodontal regeneration, alveolar ridge preservation (horizontal and vertical), sinus floor augmentation, osseointegration, peri-implantitis, and soft tissue augmentation (root coverage, keratinized tissue and soft tissue volume).