Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Flow mediated dilation of the brachial artery
研究概览
简要总结
The purpose of this study is to investigate whether basic periodontal therapy aim to reduce subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has an impact on the vascular function of patients suffering from established cardiovascular disease.
详细描述
Design: randomized clinical trial, parallel design, double blinded.
Sample: 120 patients from the Cardiology Department of Hospital Severo Ochoa (Leganés, Madrid) suffering from established cardiovascular disease and generalized moderate/severe periodontitis. Sixty patients will be randomized to test group (scaling and root planing + systemic antimicrobials), and the other 60 subjects will be included in the control group, consisting on delayed periodontal treatment (supragingival prophylaxis + placebo).
Study visits:
Visit 1: screening Visit 2: baseline data collection (medical history, clinical variables, gingival crevicular fluid (GCF) samples, vascular function) Visit 3: panoramic x-ray, blood samples, randomization and first treatment session.
Visit 4: second treatment session. Visit 5: 24 hours inflammatory biomarkers assessment. Visit 6: 7 days inflammatory biomarkers assessment. Visit 7: 1 month follow up (clinical variables) Visit 8: 3 months follow up (clinical variables, vascular function) and supportive periodontal therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) patients with established cardiovascular disease (unstable angina or stroke in the previous 3 to 12 months, and left ventricular ejection fraction ≥50%);
- •(2) diagnosis of moderate to severe generalized periodontitis (PD>5mm and marginal bone loss >30% on at least 50% of the teeth, according to Tonetti et al. 2007);
- •(3) presence of at least 3 teeth per quadrant.
排除标准
- •(1) periodontal treatment in the previous year;
- •(2) antibiotic intake in the previous 3 months;
- •(3) smokers of ≥10 cigarettes per day;
- •(4) pregnancy or breast feeding;
- •(5) diabetes mellitus types I or II, with glycosylated hemoglobin values >7;
- •(6) necrotizing periodontal diseases;
- •(7) HIV infection;
- •(8) chronic intake of NSAID
结局指标
主要结局
Flow mediated dilation of the brachial artery
时间窗: Day 0 (Baseline), Day 90, Day 180
Endothelium-dependent vasodilatation of the brachial artery assessed by means of ultrasound imaging with the use of a 7-MHz linear probe and vessel diameter measurements. Dilatation was quantified as the change in percentage form a baseline measurement and a second measurement taken after 5 minutes of flow ischemia induced with a sphygmomanometer cuff placed on the forearm.
次要结局
- Carotid artery atherosclerosis(Day 0 (Baseline), Day 90, Day 180)
- Plaque index(Day 0 (baseline), Day 30, Day 90, Day 180)
- Dental mobility(Day 0 (baseline), Day 30, Day 90, Day 180)
- Bacteria in blood samples(Day 1 (pre and post-therapy))
- Bacteria in gingival crevicular fluid(Day 0 (baseline), Day 180)
- Gingival recession(Day 0 (baseline), Day 30, Day 90, Day 180)
- Inflammatory biomarkers in serum samples(Day 1, Day 3, Day 10, Day 180)
- Periodontal pocket probing depth(Day 0 (baseline), Day 30, Day 90, Day 180)
- Bleeding on probing index(Day 0 (baseline), Day 30, Day 90, Day 180)
- Suppuration on probing index(Day 0 (baseline), Day 30, Day 90, Day 180)
- Furcation lesions(Day 0 (baseline), Day 30, Day 90, Day 180)
- Number of present teeth(Day 0 (baseline), Day 30, Day 90, Day 180)
- Radiographic bone loss(Day 0 (baseline))
研究者
Prof. Elena Figuero
Assistant Professor
Universidad Complutense de Madrid