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.

在牙科实践中塑造牙周辅助抗生素的适应症：PBRN临床试验 牙周炎是一种细菌炎症性疾病，据报道会影响近40％的美国人 年龄30岁以上。如果未治疗，牙周炎可能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疾病治疗的组成部分。但是，抗生素 管理要求合理化其处方以减少抗生素滥用和耐药性的发展 菌株。在整个医学学科中，都有一个明确的方向来确定实际上可能受益的个人 从抗生素使用并提供用于使用的准则。截至2018年，美国牙科协会已有 开发的基于证据的指南限制了牙齿中预防性抗生素使用的情况 实践;但是，在治疗牙周感染中没有国家使用抗生素的准则 由于缺乏评估疾病和人特异性适应症的足够动力试验。因此， 牙医要决定何时指示辅助抗生素，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，存在生物学原理以支持 辅助性抗生素用于针对牙周致病细菌，但其使用的临床结果具有 提出了矛盾的结果。目前，处方模式和利用率非常有限 存在抗生素作为美国从业人员中的牙周治疗辅助物。尽管如此，数据来自 学术研究表明，辅助性全身抗生素可能仅对某些人群有益， 由于对治疗的生物学反应在各个个体之间的变化很大。该明显的可变性令 与人和疾病相关特征的识别，这些特征与最大收益有关 辅助抗生素治疗。因此，可以为量身定制建立明确的准则 其使用的适应症是最终目的是最大程度地减少牙周治疗中的抗生素滥用 避免发展抗生素耐药性。这项研究的目的是评估 辅助性阿莫西林/甲硝唑组合抗生素抗生素临床中非手术牙周治疗 通过进行最大的随机临床试验（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，当前的辅助决策因素 将对抗生素处方进行调查，以评估临床实践中的状况。重要的是， 利用功能良好的RCT数据集，将确定辅助性抗生素治疗的高反应者 并且将评估临床医生当前采用的决策因素的预测有效性 制定明确的处方迹象。目前，总的来说，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，而没有循证准则， 这可能导致抗生素滥用和缺乏疗效。目前务实的功能强大的RCT是 旨在制定基于证据的牙周辅助抗生素使用指南。