Treatment of Periodontal Disease in Systemic Lupus Erytematosus: A Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To measure the effect of periodontal treatment on SLE patients
研究概览
简要总结
The primary objective of this study is to:
Part 1 - Baseline Comparisons
The primary objective of Part 1 is to:
Investigate the association between SLE and a measures of vascular health (brachial artery flow-mediated dilatyation) in patients with Systemic Lupus Erythematosus (SLE) and a healthy periodontium compared to patients with SLE and Periodontitis (PD)
Part 2 - Pilot Randomized Clinical Trial To assess the effect of Periodontal Treatment (PT) on the endothelial function in a population of patients suffering from SLE and PD.
Secondary Secondary objectives include:
Part 1 - Baseline Comparisons
The secondary objectives of Part 1 are to investigate the association of:
- Inflammatory biomarkers in saliva and blood and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium
- The oral microbiome using plaque analysis and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium Part ParPa Part 2 - Pilot Randomized Controlled Trial Evaluate the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD.
Evaluate the effect of PT on the B cell panel in a population of patients suffering from SLE and PD.
Evaluate effect of PT on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD.
Evaluate effect of PT on skin lesions in a population of patients suffering from SLE and PD.
详细描述
The primary endpoints of this study are in two parts. One part is to quantify the vascular health in response to PD as a static point prior to active therapy compared to participants with SLE and healthy perdiodontium . The second part is to quantify and compare the clinical and systemic outcomes of cases with SLE and PD following periodontalal treamtment.
Part 1 Comparative analyses between cases (SLE with PD) and controls (SLE without PD) will be performed using ANOVA analysis. Primary outcome will be the difference in flow -mediated dilatation between groups. Multivariate analysis will be performed to adjust for a number of covariates including: age, gender, body mass index, ethnicity and supragingival plaque levels.
All secondary endpoints will be analysed with ANOVA. Pre-specified analyses of secondary outcomes will include descriptive analyses and differences.
Part 2 Primary clinical periodontal outcome will be the difference in mean flow mediated (peri-implant) at 6 months between study groups and analysed by analysis of co-variance model. Age, gender, body mass index, smoking status, ethnicity and dental plaque levels will be included as additional covariates. Pair-wise comparison and between groups differences will be calculated using Tukey HSD corrections. If the normality assumption does not seem reasonable even after transformation of original values, equivalent nonparametric methods will be used.
Primary systemic inflammatory outcome will be
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
It is a single-blinded study in which cardio-vascular technician will be blinded.
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
- •Male/Female Subject must be 18 years of age or over.
- •Patients with 4 or more criteria for juvenile systemic lupus erythematosus (JSLE) or SLE according to the American College of Rheumatology (ACR) 1997 criteria or SLICC 2012 criteria or biopsy proven lupus nephritis with one additional supportive test on at least two occasions (positive Anti-nuclear antibodies (ANA), anti-dsDNA antibodies or anti-Sm antibodies).
- •Presence of moderate to severe periodontitis (at least 30 pockets with Probing depth equal or greater than 5mm).
- •Subject must have voluntarily signed the informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Having fewer than 15 teeth.
- •Subject knowingly has HIV or Hepatitis.
- •Subject is not capable to give informed consent.
- •Presence of concomitant rheumatoid arthritis, Sjogren syndrome, diabetes mellitus.
- •Subject on anticoagulants.
- •Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
- •Subjects who received periodontal treatment within 6 months from the baseline
研究组 & 干预措施
test group
intensive periodontal treatment (IPT)
干预措施: supra/sub gingival root surface debridement (Procedure)
control group
Control periodontal treatment (CPT)
干预措施: supra-gingival scaling and polishing (Procedure)
结局指标
主要结局
To measure the effect of periodontal treatment on SLE patients
时间窗: 2 years
Endothelial function/dysfunction (vessel wall elasticity) will be observed in the population of SLE patients (30) who will undergo periodontal treatment (before and after) by using Flow mediated dilatation (FMD) which is an ultra-sound scan of brachial artery in visit 2, 4 and 6).
次要结局
- To measure the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD.(2 years)
- To measure the effect of Periodontal Treatment on the B-cell panel in a population of patients suffering from SLE and PD.(2 Years)
- To measure the effect of Periodontal Treatment on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD.(2 years)
- To measure the effect of Periodontal Treatment on skin lesions in a population of patients suffering from SLE and PD.(2 years)