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Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical Trial

确定牙科实践中牙周辅助抗生素的适应症：PBRN 临床试验

基本信息

批准号：
10448940
负责人：
Georgios Kotsakis
金额：
$ 39.13万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-11 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10448940
关键词：
Academy Adult Adverse event Affect American American Dental Association Amoxicillin Antibiotic Resistance Antibiotic Therapy Antibiotics Biological Calibration Characteristics Chronic Classification Clinical Clinical Data Clinical Practice Guideline Clinical Trials Combined Antibiotics Comparative Study Conflict (Psychology)Data Data Collection Data Set Decision Making Dental Dental Clinics Dental General Practice Dental Offices Dentistry Dentists Dentition Development Diagnosis Discipline Disease Documentation Enrollment Evaluation Feasibility Studies Focus Groups Goals Guidelines Health Hemorrhage Individual Inflammatory Investigation Lead Left Link Logistic Regressions Manuals Mechanics Medical Metronidazole Modeling Monitor Morbidity - disease rate Nested Case-Control Study Oral cavity Participant Patient Recruitments Patients Pattern Periodontal Diseases Periodontal Infection Periodontitis Persons Phase Plant Roots Population Practice Guidelines Preparation Procedures Protocols documentation Randomized Randomized Clinical Trials Reporting Resistance development Sampling Studies Shapes Surveys System Tooth Loss Tooth root structure Training Translating Treatment Effectiveness U-Series Cooperative Agreements Update Work aged base clinical practice clinically significant design effectiveness evaluation efficacy outcomes evidence base evidence based guidelines instrument pathogenic bacteria pilot test pilot trial prophylactic recruit resistant strain response secondary outcome translational potential treatment optimization treatment response years lived with disability

项目摘要

Shaping the Indications for Periodontal Adjunctive Antibiotics in dental practice: A PBRN Clinical Trial Periodontitis is a bacterial inflammatory disease that has been reported to affect nearly 40% of Americans aged 30 years or older. If left untreated, periodontitis can lead to tooth loss and patient-perceived morbidity. Historically, antibiotic use has been an integral part of periodontal disease treatment. However, antibiotic stewardship calls for rationalizing their prescription to reduce antibiotic misuse and development of resistant strains. Across medical disciplines, there is a clear direction to identify individuals who in fact may benefit from antibiotic use and to provide guidelines for their use. As of 2018, the American Dental Association has developed evidence-based guidelines limiting circumstances for prophylactic antibiotic use in dental practice; however, no national guidelines exist for antibiotic use in treatment of periodontal infections because of lack of adequately powered trials assessing disease- and person-specific indications. Thus, dentists are left to decide when adjunctive antibiotics are indicated, and which dental patients need them to achieve periodontal health. In the context of periodontitis treatment, a biological rationale exists to support adjunctive antibiotic use against periodontal pathogenic bacteria, but clinical results of their use have presented conflicting results. Currently, very limited documentation of the prescription patterns and utilization of antibiotics as periodontal treatment adjuncts among US practitioners exist. Nonetheless, data from academic studies suggest that adjunctive systemic antibiotics may only be beneficial for certain populations, as the biological response to treatment is highly variable across individuals. This marked variability warrants the identification of person- and/or disease-related characteristics that are linked to maximum benefit from adjunctive antibiotic treatment. Consequently, clear guidelines can then be established for tailored indications for their use with the ultimate goal of minimizing antibiotic misuse in periodontal treatment to avoid development of antibiotic resistance. The objective of this study is to assess the effectiveness of adjunctive Amoxicillin/Metronidazole combination antibiotics to non-surgical periodontal therapy in clinical practices within the National Dental PBRN by conducting the largest randomized clinical trial (RCT) of adjunctive antibiotics. Further, within this PBRN study, current decision-making factors for adjunctive antibiotic prescription will be surveyed to assess the state of affairs in clinical practice. Importantly, leveraging the well-powered RCT dataset, high responders to adjunctive antibiotic treatment will be identified and the predictive validity of decision-making factors currently employed by clinicians will be assessed to develop clear indications for prescription. Collectively, results of adjunctive antibiotic use at present are ambiguous because indications are based on empirical information without evidence-based guidelines, which may lead to antibiotic misuse and lack of efficacy. The present pragmatic well-powered RCT was designed to enable the development of evidence-based guidelines for periodontal adjunctive antibiotic use.

塑造牙周辅助抗生素在牙科实践中的适应症：一项PBRN临床试验