Peri-implantitis in HIV-positive Patients With Different Dental Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- prevalence of peri-implantitis
研究概览
简要总结
Dental implants are widely used in human immunodeficiency virus (HIV)-positive patients, but the interaction between immune status and success of implant therapy, especially in such patients, is not clear.
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.
This cross sectional study included 85 adult HIV-positive patients (394 implants) with at least one dental implant loaded for more than a year who were followed for at least one year. The patients were divided into patients with all-on-4 prosthesis and those with single crowns/bridges to assess the differences between the two types of prostheses in the inflammatory state, in the presence of mucositis and peri-implantitis, and in the variables analyzed. The following clinical parameters were assessed: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing pocket depth (PPD) in six sites per implant and tooth (deepest value for each implant and tooth was registered), PI and BoP measured as presence/absence at six sites per implant and tooth, presence of suppuration, mobility (measured by manual palpation) and number of lost teeth.
详细描述
2.1 Study design This cross-sectional mono-centric observational study assessed the prevalence of peri-implant disease in HIV-positive patients and was performed in accordance with the Helsinki Declaration of Human Studies. All procedures were approved by the Ethics Committee of Vita-Salute San Raffaele University (on 15/7/2020 with number of protocol "PERIHIV"-EC Reg. N. 10/INT/2020) in Milan, Italy. This study has been reported according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines and checklist.
2.2 Patient sample Each patient was informed about all pertinent aspects of the study by the investigator (LC), and an appropriate informed consent was obtained prior to the start of the study. The study included 85 adult patients between 46.56 and 55.6 years (median 51.32 years) with at least one dental implant and a total of 394 dental implants with a mean follow-up of 3 years (range from 2 years to 5 years). Demographic, clinical, and laboratory information of the patients was collected and implant were positioned in the same Hospital in which patients are in treating with antiretroviral therapy for the HIV-infection (Ville Turro Dental Clinic of Vita-Salute San Raffaele University in Milan).
2.3 Inclusion and exclusion criteria All patients (>18 years old) who had undergone prosthetic rehabilitation using one or more dental implants, with at least 1 year of follow-up after loading, and who had returned for a maintenance appointment at the Ville Turro Dental Clinic of Vita-Salute San Raffaele University in Milan. All patients were undergoing antiretroviral therapy (ART) at the same hospital. Patients who discontinued antiretroviral therapy and patients not undergoing therapy, subjects with uncontrolled systemic diseases (diabetes [HbA1c>7]) or under treatment with any medications that may have an effect on bone turnover and mucosal healing (steroids, bisphosphonate therapy ) were excluded. Pregnancy or breastfeeding women were also excluded. All patients were included in a maintenance oral hygiene program (every 4 months) and who discontinued the oral maintenance (more than 1 appointment) were excluded from the study.
2.4 surgery procedure All implants were placed by two skilled implant surgeons; most of the implants (328) were 3,8 mm diameter (83.2%), 46 were 3,3 mm (11.7%) and 20 were 4,5 mm (5.1%). Implants were placed at level or slightly below the bone crest (1 mm) and in all cases the complete bone healing was reached (at least 3 months) before implant loading. Bone healing was assessed after at least 3 months of undisturbed healing, with periapical radiographs and if confirmed, final impression was taken. For implant-supported single crown and bridge, after final impression, definitive cemented single crown or bridge were achieved. Only in cases of not adequate prosthetic space, with not sufficient abutment retention for cemented prostheses, screw-retained prosthetic rehabilitations were made. Regarding the full arch rehabilitations, the all-on-four protocol described by Malò were followed in all cases. In addition the bone was leveled before implant placement using a rongeur and with the aid of the carbide burs in order to form a flat bone plane in which place the implant. This allows the elimination of the bone spicules, fractured bone and damaged buccal bone and the creation of a flatbed in which was easy to insert the implants and achieve the prosthetic rehabilitation. Two implants were placed in the posterior sectors (tilted) and two in the anterior sector (straight) after the bone leveling.
2.4 Clinical evaluation Data pertaining probing pocket depth (PPD), bleeding on probing (BoP) and plaque index (PI) around the implants and teeth of HIV-positive patients included in the study were collected by probing implant and dental sulcus with a calibrated dental probe (0,25 N)(Hawe Click-Probe®, KerrHawe SA, Switzerland) by one skilled operator (L.C.). The following clinical parameters were assessed: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing pocket depth (PPD) in six sites per implant and tooth (deepest value for each implant and tooth was registered), PI and BoP measured as presence/absence at six sites per implant and tooth, presence of suppuration, mobility (measured by manual palpation) and number of lost teeth. Demographic data and implant site characteristics were checked in a specific case report form. For each HIV-positive patients, the following information was reported: age, gender, smoking habit (number of cigarettes), number of dental implants, health condition (i.e. diabetes presence), history of periodontitis and frequency of maintenance (number of maintenance appointments in 1 year). Data relating to the immunological and systemic profile of the patients (HIVRNA load, CD4+ level, CD8+ level, hemoglobin level, platelet count) were collected through the database of the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (>18 years old) who had undergone prosthetic rehabilitation using one or more dental implants, with at least 1 year of follow-up after loading, and
- •patients who had returned for a maintenance appointment at the Ville Turro Dental Clinic of Vita-Salute San Raffaele University in Milan
- •patients under antiretroviral therapy (ART) at the same hospital.
排除标准
- •Patients who discontinued antiretroviral therapy
- •patients not undergoing therapy
- •patients with uncontrolled systemic diseases (diabetes [HbA1c>7])
- •patients under treatment with any medications that may have an effect on bone turnover and mucosal healing (steroids, bisphosphonate therapy )
- •Pregnancy or breastfeeding women
- •patients who discontinued the oral maintenance (more than 1 appointment)
结局指标
主要结局
prevalence of peri-implantitis
时间窗: 01/01/2015 - 01/01/2020
peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with a progressive loss of supporting bone
次要结局
未报告次要终点
研究者
Luca Casula
MD, Msc
Università Vita-Salute San Raffaele
