The Experimental Gingivitis Model: key elements for conduction and design workshop

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1 The Experimental Gingivitis Model: key elements for conduction and design workshop September 28 th 29 th, 2015 School of Dentistry, University of Ferrara, Research Center for the Study of Periodontal and Peri implant Diseases,University of Ferrara

2 WORKSHOP BACKGROUND The experimental gingivitis (EG) model, i.e. the induction of gingival inflammation under supervised conditions of oral biofilm development, was initially developed in 1965 by Löe and co workers as a tool to demonstrate the relationship between plaque and gingivitis. In the last 40 years, the EG model has been repeatedly validated in humans, primates and other mammals, and extensively used for the study of gingivitis and evaluation of therapeutic interventions. As of February 2013 more than 370 references resulted from a Medline search using the term "experimental gingivitis". Due to the fact that it is safe and fully reversible, thus precluding any permanent damage to the participants, the EG model has been largely applied in periodontal research and contributed mightily in understanding gingivitis etiopathogenesis and characterizing factors which modulate the gingival host response to dental plaque accumulation. Also, the EG model is useful in the study of anti plaque and anti gingivits agents. In this respect, it allows for determining whether and to what extent such agents may sustain the reversal of gingival inflammation by direct comparison with conventional mechanical plaque control alone under standardized conditions of acute, marked plaque accumulation and gingival inflammation. Over the years, several modifications of the original EG model have been proposed to minimize patient discomfort as well as optimize the conditions for the experimental assessments. Also, a series of new clinical, microbiological, immunological and genetic parameters have been proposed and investigated to characterize the inflammatory status of gingival tissues under experimental conditions. Since the 90 s, the EG model was also applied to implant sites for the study of plaque induced inflammation of the peri implant tissues (i.e., peri implant mucositis). The aim of the Workshop is to provide young Researcher with the knowledge to set an EG protocol which best tackles the purpose(s) of your study. Structure of the Workshop The Workshop consists of an intensive program (from Monday, 9 am to Tuesday, 2 pm) entirely dedicated to improve the knowledge of EG models ad its research applications. The Workshop includes lectures (aimed at providing participants with the basis to design and conduct an EG study) and training sessions (consisting of the supervised assessment of experimental clinical parameters). Topics The contents of the Workshop will be based on the following major topics: structure of an EG trial and different EG models; criteria for the selection of patients and sites; selection and assessment of experimental clinical parameters; statistical methods for data analysis. Learning Objectives At the completion of the 2 day program, Workshop attendants will dispose of the necessary information and training to: understand the fundamentals of EG; plan an EG study design; have knowledge on data collection and analysis. 1

University of Ferrara.Director, Research Center for the Study of Periodontal and Peri implant Diseases,University of Ferrara. Director, Dental Clinic, University Hospital, Ferrara.

3 SPEAKERS Prof. Leonardo Trombelli, DDS PhD Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara, Italy Full Professor and Chair, Periodontology, School of Dentistry, University of Ferrara.Director, Research Center for the Study of Periodontal and Peri implant Diseases,University of Ferrara. Director, Dental Clinic, University Hospital, Ferrara. Dean, School of Dentistry, University of Ferrara. Past President of the Italian Society of Implantology ( ). Active member of Italian Society of Periodontology, Italian Society of Implantology, International Association for Dental Research, and International Academy of Periodontology. Editorial Board member for the Journal of Clinical Periodontology, member of the Peer review panel for the Journal of Periodontology. Dr. Roberto Farina, DDS PhD MSc Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara Full time Researcher in Periodontology and Oral Implantology, University of Ferrara. Chair, Oral Implantology, School of Dentistry, University of Ferrara. Member, Directive Council of the Research Centre for the Study of Periodontal and Peri Implant Diseases, University of Ferrara, Italy (Director: Prof. L. Trombelli). Course director, post graduate program in Oral Implantology, University of Ferrara. Degree in Dentistry (2003). Ph.D., Oral and Maxillofacial Surgery (2007). Research fellowship, Center for Craniofacial Regeneration, University of Michigan (2007). M.Sc., Clinical and Epidemiological Research (2009). Dr. Farina s research interests are limited to periodontology and implantology and include pathogenetic, diagnostic as well as preventive and therapeutic aspects of plaque induced periodontal and peri implant diseases. To date, Dr. Farina has published textbook chapters and several highly cited articles in the major international, peer reviewed scientific journals of the dental area. Also, Dr. Farina serves on the peer review panel of some of the most important international scientific journals in his research field. 2

Dr. Maria Elena Guarnelli, DDS Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara, Italy Degree in Dentistry, University of Ferrara, Italy.

Research assistant, Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara, Italy.

4 Dr. Maria Elena Guarnelli, DDS Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara, Italy Degree in Dentistry, University of Ferrara, Italy. Internship at the Advanced Education Program in Loma Linda University, School of Dentistry, CA. Research assistant, Research Centre for the Study of Periodontal and Peri implant Diseases, University of Ferrara, Italy. Research assistant, Operative Unit of Dentistry, University Hospital of Ferrara, Italy. Part time faculty, School of Dentistry and School of Dental Hygiene, University of Ferrara, Italy. Member, Directive Council, Research Centre for the Study of Periodontal and Peri Implant Diseases, University of Ferrara. Author and co author of publications in the field of Periodontology on peer reviewed journals. Prof. Chiara Scapoli, PhD Department of Health Sciences and Biotechnologies, University of Ferrara, Italy Degree in Biological Sciences, University of Ferrara. Doctorate in Genetics, University of Ferrara. International Master in Genetic Epidemiology, European School for Advanced Studies in Molecular Medicine and Genetic Epidemiology. Full Professor of Genetics and Director of the Department of Health Sciences and Biotechnologies, University of Ferrara. Active Member of the International Biometrics Society and the Italian Genetics Association. Council Member of the Italian Genetics Association. 3

5 PROGRAMME Full programme for The experimental gingivitis model: key elements for study design and conduction Workshop 2014 and social event Workshop Venue- Hotel Carlton Ferrara Septmeber 28 th Topic Speakers Welcome -Presentation of the Workshop Prof. L. Trombelli The experimental gingivitis (EG) model - The EG model: overview and research applications - Naturally-occurring and experimentally-induced inflammation: similarities and differences - Experimental designs - Methods for plaque accumulation - Full-mouth vs. partial mouth models Coffee break Setting up an EG trial: parameter selection - C Setting up an EG trial: parameter selection - Clinical parameters - GCF sampling and assessment clinical parameters - GCF sampling and assessment Setting up an EG trial: predisposing and modifying factors - Systemic factors - Local factors 13:00-14:30 Lunch Setting up an EG trial: implementing the protocol for the evaluation of anti-plaque or 4

6 anti-gingivitis agents - Assessing the efficacy of anti-plaque and antigingivitis agents in an EG protocol - Optimization and evaluation of panellist compliance Dealing with data from an EG trial - Sample size calculation - Scores for intra- and inter-examiner agreement - The statistical unit: site or patient? - Planning and interpreting a multilevel analysis Prof. C. Scapoli Social Event Dinner at the Hotel Carlton Ferrara Workshop Venue - University of Ferrara September 29 th Topic Speakers Assessing the clinical parameters: video session (I) - Briefing on the objectives of the training session - Assessing the Plaque Index - Assessing the Gingival Index - Assessing the Angulated Bleeding on Probing - Assessing the Gingival Crevicular Fluid Prof. L. Trombelli, Dr. M.E. Guarnelli, Dr. R. Farina 11: Coffee break Assessing the clinical parameters by participants: video session (II) Prof. L. Trombelli, Dr. M.E. Guarnelli, Dr. R. Farina 14:00-14:10 Farewell - Presentation of Certificates 5

7 14:15 Lunch at Hotel Carlton Ferrara 6

SKIING AND LEARNING IN THE DOLOMITES

SKIING AND LEARNING IN THE DOLOMITES NEW TRENDS IN IMPLANTOLOGY AND REGENERATIVE PROCEDURES IN THE HEART OF THE DOLOMITES January 13 19, 2019 San Cassiano Alta Badia - Italy Speakers Dr. Paolo Casentini