Cloitre Alexandra, Duval Xavier, Boutoille David, Péré Morgane, Garreau Astrid, Fouchard Swanny, Poinas Alexandra, Lesclous Philippe
Nantes Université, Univ Angers, CHU Nantes, INSERM, Regenerative Medicine and Skeleton, RMeS, UMR 1229, Oniris, Nantes, F-44000, France.
AP-HP, Hôpital Bichat, INSERM CIC 1425, Université Paris Cité, IAME, INSERM, Paris, France.
BMC Oral Health. 2025 Jul 2;25(1):1045. doi: 10.1186/s12903-025-06473-6.
Infective endocarditis (IE) is a serious and costly infectious disease associated with high morbidity and mortality. The oral cavity is the second most common source of IE accounting for approximately 30% of cases. Detection and management of oral infectious foci (OIF) are therefore critical to reduce IE incidence, relapse or recurrence. Current guidelines recommend the systematic detection and elimination of OIF in IE patients through clinical oral examination and orthopantomogram (OPT). Despite these recommendations, the annual incidence of IE has remained stable. Cone Beam Computed Tomography (CBCT), offers significantly improved diagnostic accuracy over OPT for the detection of OIF. For this randomized clinical trial (RCT), we hypothesize that in IE patients, systematic evaluation using CBCT would identify more OIF than OPT, thereby improving oral health status and potentially reducing the risk of IE recurrence.
This is a prospective, 2-parallel arms, superiority and individual-based RCT. The main objective is to compare the efficacy of two personalized management strategies on IE patient’s oral health status at 12 months regardless of the microorganism responsible for IE. We hypothesize that the experimental strategy based on clinical oral examination combined with CBCT is superior to the reference strategy based on clinical oral examination combined with OPT, performed at the time of IE. The primary endpoint is a “perfect” oral health status defined as a complete absence of OIF on CBCT performed in all patients combined with clinical examination at 12 months. 170 patients meeting the inclusion criteria will be enrolled. This number was calculated based on preliminary assumptions of the main criterion. Analyses will be conducted on data from the modified intention-to-treat population and the per-protocol population.
The data generated by this study may improve the therapeutic management of patients with IE and potentially decrease the rate of IE recurrence. This should enable cost/effectiveness studies to be conducted on the prevention of IE. In addition, the recommendations for good practice and the training of healthcare professionals involved in the management of patients with IE could be updated with data of high level of evidence.
ClinicalTrials.gov (NCT06269679 on February 13td, 2024).
The online version contains supplementary material available at 10.1186/s12903-025-06473-6.
感染性心内膜炎（IE）是一种严重且代价高昂的传染病，发病率和死亡率都很高。口腔是IE的第二大常见感染源，约占病例的30%。因此，检测和处理口腔感染灶（OIF）对于降低IE的发病率、复发率至关重要。目前的指南建议通过临床口腔检查和曲面体层摄影（OPT）对IE患者进行系统性的OIF检测和清除。尽管有这些建议，但IE的年发病率仍保持稳定。锥形束计算机断层扫描（CBCT）在检测OIF方面比OPT具有显著更高的诊断准确性。在这项随机临床试验（RCT）中，我们假设在IE患者中，使用CBCT进行系统性评估比OPT能发现更多的OIF，从而改善口腔健康状况并可能降低IE复发的风险。
这是一项前瞻性、双臂平行、优效性和基于个体的RCT。主要目的是比较两种个性化管理策略对IE患者12个月时口腔健康状况的疗效，而不考虑导致IE的微生物种类。我们假设基于临床口腔检查联合CBCT的实验策略优于基于临床口腔检查联合OPT的对照策略，后者在IE发病时进行。主要终点是“完美”的口腔健康状况，定义为在12个月时对所有患者进行CBCT检查并结合临床检查，结果显示完全不存在OIF。将招募170名符合纳入标准的患者。这个数字是根据主要标准的初步假设计算得出的。将对改良意向性分析人群和符合方案人群的数据进行分析。
本研究产生的数据可能会改善IE患者的治疗管理，并可能降低IE的复发率。这将有助于开展关于IE预防的成本效益研究。此外，对于参与IE患者管理的医疗专业人员的良好实践建议和培训，可以根据高水平证据的数据进行更新。
ClinicalTrials.gov（2024年2月13日，NCT06269679）。
在线版本包含可在10.1186/s12903 - 025 - 06473 - 6获取的补充材料。
