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.

确定牙科诊所中牙周辅助抗生素的适应症：PBRN 临床试验牙周炎是一种细菌性炎症性疾病，据报道影响近 40% 的美国人 30岁或以上。如果不及时治疗，牙周炎会导致牙齿脱落和患者感知的发病率。从历史上看，抗生素的使用一直是牙周病治疗的一个组成部分。然而，抗生素管理人员呼吁合理化处方，以减少抗生素滥用和耐药性的产生菌株。在整个医学学科中，有一个明确的方向来识别实际上可能受益的个人防止抗生素的使用并为其使用提供指南。截至 2018 年，美国牙科协会已制定了基于证据的指南，限制牙科预防性使用抗生素的情况实践;然而，尚无关于使用抗生素治疗牙周感染的国家指南因为缺乏评估疾病和个人特定适应症的足够有力的试验。因此，牙医需要决定何时需要辅助抗生素，以及哪些牙科患者需要它们实现牙周健康。在牙周炎治疗的背景下，存在生物学原理支持抗生素辅助治疗牙周病原菌，但其使用的临床结果提出了相互矛盾的结果。目前，处方模式和使用的记录非常有限美国医生中存在使用抗生素作为牙周治疗辅助手段的情况。尽管如此，数据来自学术研究表明辅助全身抗生素可能只对某些人群有益，因为个体对治疗的生物反应差异很大。这种显着的可变性保证了识别与最大利益相关的个人和/或疾病相关特征辅助抗生素治疗。因此，可以为量身定制制定明确的指导方针其使用适应症的最终目标是最大限度地减少牙周治疗中抗生素的滥用避免抗生素耐药性的发展。本研究的目的是评估以下方法的有效性阿莫西林/甲硝唑联合抗生素辅助非手术牙周治疗的临床效果通过在国家牙科 PBRN 内进行最大的随机临床试验 (RCT) 进行实践辅助抗生素。此外，在这项 PBRN 研究中，目前辅助治疗的决策因素将对抗生素处方进行调查，以评估临床实践的状况。重要的是，利用功能强大的随机对照试验数据集，将确定对辅助抗生素治疗的高反应者临床医生目前采用的决策因素的预测有效性将被评估制定明确的处方适应症。总的来说，目前辅助抗生素使用的结果是模棱两可，因为适应症是基于经验信息而没有基于证据的指导方针，这可能导致抗生素滥用和缺乏疗效。目前的务实有力的 RCT 是旨在制定牙周辅助抗生素使用循证指南。