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临床试验/NCT04829968
NCT04829968已完成不适用

Valutazione Del Profilo di Emergenza e Del Sovracontorno in Corone Protesiche Complete su Denti Naturali Preparati Senza Linea di Finitura (BOPT): Studio Retrospettivo

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Peri-implantitis prevalence

研究概览

简要总结

Objectives: This study aimed to assess the prevalence of peri-implantitis in human im-munodeficiency virus (HIV) -positive patients and the presence of a possible correlation between the immunological profile and serological values, of peri-implantitis, and of pos-sible differences between all-on-4 and single crown/bridge prostheses.

Subjects and methods: This retrospective study included 58 adult HIV-positive patients (222 implants) with either all-in-4 prostheses or single crowns/bridges on at least one dental implant loaded for more than a year who were followed for at least one year. Data pertaining to the probing pocket depth (PPD), bleeding on probing, and immunological and systemic profile were collected.

Results: Patients with single crown/bridge implant rehabilitation showed higher preva-lence of peri-implantitis (34%) than patients with all-on-4 rehabilitation (0%) (p=0.012). Patients with all-on-4 rehabilitation were significantly older than those with single crowns/bridges (p=0.004). Patients with peri-implantitis had implants for a significantly longer duration than those without (p=0.001), implying that the probability of peri-implantitis increases as the age of implant increases.

Conclusions: The prevalence of peri-implantitis was 26% in HIV-positive patients and 8% in dental implants. No correlation was found between patients' immunological and se-rological factors and peri-implantitis. The most important risk factor for peri-implantitis and mucositis was implant age.

详细描述

2.1 Type and sample of the study This retrospective monocentric observational study assessed the prevalence of peri-implant disease in HIV-positive patients treated at the department of dentistry of our hos-pital. At the same hospital, the HIV-positive patients were undergoing antiretroviral treat-ment. This study included 58 adult patients with at least one dental implant and a total of 222 implants followed for at least one year. Demographic, clinical, and laboratory infor-mation of the patients was collected. All procedures were approved by the appropriate lo-cal ethics committee. Appropriate informed consent forms were provided to all patients and were signed if the patients agreed to participate in the study.

This study has been reported according to the STrengthening the Reporting of OBserva-tional studies in Epidemiology (STROBE) guidelines and checklist.

2.2 Study design All included patients were divided into two groups, according to the type of prosthesis in-serted after implant placement (all-on-4 prosthesis versus single crowns\bridges), to as-sess the differences between the two types of prostheses in the inflammatory state, and therefore, in the presence of mucositis and peri-implantitis as well as in the variables ana-lysed.

As shown in Table 1, the data related to the immunological and systemic profile of the pa-tients (HIVRNA load, CD4+ level, CD8+ level, haemoglobin level, and platelet count) were collected through the database of the hospital.

2.3 Case definition for peri-implant condition: The clinical and radiological data for the diagnosis of peri-implant disease were collected according to the criteria laid in the Periodontology World Workshop in 2017 by Renvert et al. (2018).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

接受健康志愿者

入选标准

  • Inclusion criteria All patients (>18 years old), who were undergoing antiretroviral therapy at the same hos-pital, who had undergone prosthetic rehabilitation using one or more dental implants, with at least one year of follow-up after loading, and who had returned for a maintenance ap-pointment were considered for inclusion.

排除标准

  • Exclusion criteria Patients who discontinued antiretroviral therapy, patients not undergoing therapy, patients whose previous radiographs and data on bleeding on probing and PPD at gingival level were unknown, patients with decompensated systemic diseases (for example, decompen-sated diabetes mellitus), patients treated with drugs that affect the bone turnover (for ex-ample, bisphosphonates), and patients under 18 years of age were not included in this study.

结局指标

主要结局

Peri-implantitis prevalence

时间窗: 3 years

This study aimed to assess the prevalence of peri-implantitis in HIV-positive patients and to evaluate the presence of a possible correlation between the immunological profile and serological values of the same HIV-positive patients, of peri-implantitis, and of possible differences between all-on-4 and single crown/bridge prostheses in terms of peri-implant disease and the variables analyzed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Casula

MD, MSc resident in Oral Surgery

Università Vita-Salute San Raffaele

研究点 (1)

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