Hazenberg Hanna M J L, Dubbink Jan Henk, Sesay Issa, Versteege Tom, Bangura Hassan, Hoevenaars Louise K, Falama Abdul M, Koudijs Heleen M, Roemers Rosa, Bache Emmanuel B, Kelling Emil F, Schaumburg Frieder, Spijkervet Fred K L, Grobusch Martin P
Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam University Medical Center, Location Amsterdam Medical Center, Amsterdam, The Netherlands.
Masanga Medical Research Unit, Masanga Hospital, Masanga, Sierra Leone.
JMIR Res Protoc. 2021 Dec 13;10(12):e33677. doi: 10.2196/33677.
Deficits in global oral health care are paramount, and complications of odontogenic infections constitute a considerable global health problem, particularly in low-income countries. A high mortality rate has been observed for patients who have been admitted with complicated odontogenic infections to our facilities in Tonkolili District, Sierra Leone, although exact data have not been published yet. Data regarding who in this region is at risk and why are lacking.
The Dental Abscess Study (DELAY) aims to prospectively investigate morbidity and mortality from complicated dental abscesses and to analyze patients' characteristics and microbial findings to examine predisposing factors for poor outcomes. In particular, the incidence and the clinical and microbial characteristics of complicated odontogenic infections, as well as the sociodemographic data and comorbidities of affected patients, will be studied to develop improved management algorithms based on circumstance-specific factors.
Patients who present with complicated dental infections requiring hospital admission in Masanga Hospital or Lion Heart Medical Centre will be consecutively selected for possible inclusion in the study (starting on September 4, 2021) over a study period of 1 year, and individual routine follow-ups will be conducted at least 3 months after discharge. The results of standardized questionnaires will be obtained, and clinical measurements as well as medical photos will be taken. Standard laboratory tests (eg, full blood count and HIV status tests) will be performed, and pus specimens will be examined. Local treatment guidelines will be adhered to, and data on medical and surgical treatment as well as data on outcomes will be collected. The study results will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria. Routine follow-ups will take place at 1 and 3 months postdischarge.
The DELAY protocol was endorsed by the Masanga Medical Research Unit's Scientific Review Committee on June 16, 2021, and ethical approval was granted on July 5, 2021, by the Sierra Leone National Ethics Committee. The funding of the budgeted study costs was approved by Dental Health International Netherlands in August 2021. The projected start date of data collection was September 4, 2021, and the study period will most likely last for 1 year. As such, data collection is expected to be complete in November 2022.
The aim of our prospective observational cohort study is to gain more knowledge about complicated odontogenic infections in Tonkolili District, Sierra Leone, to further improve treatment strategies.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33677.
全球口腔卫生保健存在严重不足,牙源性感染的并发症构成了一个相当严重的全球健康问题,尤其是在低收入国家。在塞拉利昂通科利利区,因复杂牙源性感染入住我们医疗机构的患者死亡率较高,不过确切数据尚未公布。该地区关于哪些人面临风险以及原因的数据也很缺乏。
牙脓肿研究(DELAY)旨在前瞻性地调查复杂牙脓肿的发病率和死亡率,并分析患者特征及微生物学检查结果,以探究不良预后的诱发因素。特别是,将研究复杂牙源性感染的发病率、临床和微生物学特征,以及受影响患者的社会人口统计学数据和合并症,以便根据具体情况制定改进的管理算法。
在1年的研究期间(从2021年9月4日开始),将连续选取在马桑加医院或狮心医疗中心因复杂牙感染需要住院治疗的患者纳入研究,出院后至少3个月进行个体常规随访。获取标准化问卷的结果,进行临床测量并拍摄医学照片。进行标准实验室检查(如全血细胞计数和艾滋病毒检测),并对脓液标本进行检查。遵循当地治疗指南,收集医疗和手术治疗数据以及结局数据。研究结果将根据STROBE(加强流行病学观察性研究报告)标准进行报告。出院后1个月和3个月进行常规随访。
DELAY方案于2021年6月16日得到马桑加医学研究单位科学审查委员会的认可,并于2021年7月5日获得塞拉利昂国家伦理委员会的伦理批准。预算研究费用的资金于2021年8月得到荷兰国际牙科健康组织的批准。预计数据收集开始日期为2021年9月4日,研究期很可能持续1年。因此,预计数据收集将于2022年11月完成。
我们前瞻性观察队列研究的目的是获取更多关于塞拉利昂通科利利区复杂牙源性感染的知识,以进一步改进治疗策略。
国际注册报告识别码(IRRID):DERR1-10.2196/33677