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

• 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
• 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

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.

确定牙周辅助抗生素在牙科实践中的适应症：一项PBRN临床试验 牙周炎是一种细菌性炎症性疾病，据报道，近40%的美国人患有牙周炎 年龄在30岁或以上。如果不治疗，牙周炎可能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中不可或缺的一部分。然而，抗生素 管理部门要求理顺他们的处方，以减少抗生素的滥用和耐药性的发展 菌株。在医学学科中，有一个明确的方向来确定实际上可能受益的个人 抗生素的使用，并为其使用提供指南。截至2018年，美国牙医协会已 制定循证指南，限制牙科预防性使用抗生素的情况 实践；然而，没有关于在牙周感染治疗中使用抗生素的国家指南 因为缺乏评估疾病和人的特定适应症的充分有力的试验。因此， 牙科医生可以决定何时使用辅助抗生素，以及哪些牙科患者需要使用。 实现牙周健康。在牙周炎治疗的背景下，存在生物学原理来支持 抗牙周病原菌的辅助抗生素使用，但其临床效果 提出了相互矛盾的结果。目前，有关处方模式和使用的文档非常有限 抗生素作为牙周治疗附件在美国从业者中存在。尽管如此，来自 学术研究表明，辅助性全身抗生素可能只对某些人群有益， 因为对治疗的生物反应在不同的人之间是高度不同的。这种明显的变异性证明了 确定与个人和/或疾病相关的特征，从而最大限度地从 辅助抗生素治疗。因此，然后可以为定制建立明确的指导方针 它们的使用适应症，最终目标是尽量减少在牙周治疗中滥用抗生素 避免产生抗药性。这项研究的目的是评估 阿莫西林/甲硝唑联合抗生素在牙周非手术治疗中的临床应用 通过进行最大规模的随机临床试验(RCT)在国家牙科PBRN中的实践 辅助抗生素。此外，在这项PBRN研究中，目前对辅助词的决策因素 将调查抗生素处方，以评估临床实践中的情况。重要的是 利用功能强大的随机对照试验数据集，将确定辅助抗生素治疗的高应答者 临床医生目前使用的决策因素的预测有效性将被评估为 制定明确的处方适应症。总的来说，目前辅助使用抗生素的结果如下 含糊不清是因为适应症是基于经验信息而没有基于证据的指导方针， 这可能会导致抗生素的滥用和疗效的丧失。目前实用的、功能强大的RCT是 旨在为牙周辅助抗生素的使用制定循证指南。