Correlation Between Peri-implantitis and Assumptions of Medications: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Risk of peri-implantitis
研究概览
简要总结
The aim of the study is to investigate the correlation between the assumption of systemic medications (such as SSRI, PPI, anti-inflammatory drugs and anti-hypertensive drugs) and the failure of dental implant therapy in terms of occurrence peri-implantitis and/or implant failure.
The clinical records of all subjects treated with dental implants during the period between January 1st, 2005, and December 31st, 2020 in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Inclusion criteria: i) subjects who were 18 years old or older at the time of intervention; ii) subjects who provided their informed consent for the intervention iii) patients with total or partial edentulism treated with dental implants; iv) patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
Exclusion criteria: i) incomplete data (e.g. absence of periapical radiographs) Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of each drug on survival curves.
The level of significance was set at p<0.05. The sample size was calculated in order to evaluate the hazard risk of patients exposed to each specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. On the basis of a hypothesized 5-year incidence of peri-implantitis of 0.16, HR = 2, and a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed).
详细描述
Global demographic trends clearly show the increase in life expectancy and, as a direct consequence of progressive aging, the prevalence of disabling diseases with the relative intake of drugs. The intake of drugs such as thiazide diuretics, beta-blockers, anti-inflammatories, proton pump inhibitors and serotonin re-uptake inhibitors has been shown to be able to modulate bone metabolism with different mechanisms. Thus, they may be able to influence peri-implant health.
Proton pump blockers (PPIs) are a class of gastric acid secretion inhibitors that are currently among the best-selling drugs worldwide. The use of PPIs, especially at high doses and/or in long-term treatments, has been associated to an increased risk of hip, wrist and spine fractures. Different mechanisms have been suggested to explain the effects of PPIs on bone metabolism, which include: reduction of calcium absorption due to an increased pH in the small intestine; reduction of the osteoclastic resorption activity due to the modulation of vacuolar ATPase (V-ATPase) at the membrane level in the vesicles of osteoclasts; inhibition of non-specific alkaline phosphatase (ALP) and FOSFO1 in the vesicles of the bone matrix, increasing the expression of osteocalcin and the osteoprotegerin/RANKL ratio.
Selective serotonin reuptake inhibitors (SSRIs) are currently among the most common antidepressants and their main indications are major depression, generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, panic attack syndrome and bulimia. The action of selective serotonin reuptake inhibitors (SSRIs) on certain receptors and transporters such as 5-HT1B, 5-HT2B or 5-HT2C can result in impaired bone metabolism through increased differentiation and activation of osteoclasts. Reductions in bone mineral density (BMD) have been described, among others, in patients suffering from depressive syndromes which appear to be related to alterations in serotonin function. These findings suggest the hypothesis that SSRIs may have an impact also on the osseointegration process.
Anti-hypertensive drugs medications have been proven to interfere with bone metabolism through different mechanisms. For example, beta-blockers and angiotensin-converting enzyme inhibitors are able to inhibit osteoclasts activity by blocking the surface β-2 adrenergic receptors, which affects the renin-angiotensin system, while thiazides may enhance bone formation by increasing calcium absorption at the distal convoluted tubule.
Systemic corticosteroids are associated to various adverse reactions, especially when used at high doses or for long periods. Fracture and osteoporosis are among the most common corticosteroid-related adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •subjects who were 18 years old or older at the time of intervention
- •subjects who provided their informed consent for the intervention
- •patients with total or partial edentulism treated with dental implants
- •patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
排除标准
- •Incomplete data (e.g. absence of periapical radiographs)
结局指标
主要结局
Risk of peri-implantitis
时间窗: 0 to 15 years
Hazard risk of incurring in peri-implantitis in subjects assuming systemic medications (SSRIs, PPIs, anti-inflammatory drugs, and anti-hypertensive drugs)
次要结局
- Influence of drugs on implant survival curves and peri-implantitis(0 to 15 years)
- Dosage and peri-implantitis(0 to 15 years)
- Dosage and implant failure(0 to 15 years)
