Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- clinical attachment level
研究概览
简要总结
The purpose of the study was to monitor the activity of periodontal disease and suggest potential biomarkers related to active periodontal disease in patients with chronic periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the evaluation of the profile of gene expression of periodontal sites and the evaluation of inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2 months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group). Fifteen periodontal- and systemically healthy patients were included as control group. Saliva collection, glycated hemoglobin measurement, periodontal examination and radiographs were conducted before and 2 months after non-surgical periodontal therapy. Radiographic subtraction was performed from pairs of the radiographs. Measurements of the areas with density loss were recorded. Gingival biopsies of active and non-active sites with similar clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM group (p<0.05). There was a high correlation between clinical attachment loss and darkened radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group showed nine genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. After periodontal therapy, there was a reduction of some salivary proteins in both periodontal groups, but not significant. In conclusion, it was possible to identify genes differentially expressed in active sites from both groups, which may be considered useful in indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a trend in distinguishing the standard of health and disease and may be used in the future as potential biomarkers of periodontitis with or without diabetes.
详细描述
This case-control longitudinal study was carried out at University of São Paulo between March 2009 and June 2012 as a joint collaboration of the Department of Oral Surgery and Periodontology and the Department of Internal Medicine, Division of Endocrinology and Metabolism. It was reviewed and approved by the Institutional Human Ethics Research Committee of the Ribeirão School of Dentistry - University of Sao Paulo (process n. 2009.1.88.58.7).
The clinical attachment loss above 1 mm was determined according to the tolerance method adapted to the computerized periodontal probe, considering the standard deviation of 0.3 mm for the electronic probe multiplied by 3. Teeth with prosthesis or furcation lesions were not considered. The periodontal sites that had this clinical attachment were called active sites.
Before beginning the initial clinical examination, a supragingival scaling with ultrasonic device was performed to facilitate the examination. The clinical parameters evaluated were: probing pocket depth, relative clinical attachment level and bleeding on probing were recorded at six sites per tooth with the aid of a computerized periodontal probe. To reduce the variations between baseline and 12-month evaluations, an acrylic stent was used to standardize the position of the computerized periodontal probe. Bleeding on probing was assessed according to presence or absence of bleeding up to 20 seconds after probing. The plaque index, presence or absence of biofilm, was recorded at four sites per tooth. It was also verified the furcation involvement with the aid of a manual periodontal probe.
All clinical parameters were recorded two weeks after supragingival scaling (baseline) and two months after non-surgical periodontal therapy by one-blinded calibrated examiner. A calibration exercise was performed to achieve acceptable intraexaminer reproducibility.
For the metabolic control assessment, the HbA1c levels were analyzed in patients from both groups at baseline and two months after non-surgical periodontal therapy, at the Endocrinology Clinic of the Ribeirão Preto School of Medicine, University of São Paulo. All diabetics were under the supervision of an endocrinologist advised to communicate any change in medicine intake or diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults aged between 35 to 65 years old;
- •a minimum of 14 natural teeth, 10 of which should be posterior teeth;
- •periodontitis case definition was the presence of five teeth with a probing pocket depth of ≥ 5 mm and clinical attachment loss of ≥ 3 mm;
- •type 2 diabetes for at least 5 years and with glycated hemoglobin level > 7%.
排除标准
- •smoking within the last 5 years;
- •pregnancy or lactating;
- •use of antibiotics or periodontal therapy in the previous six months;
- •concomitant medical therapy, except for diabetic condition;
- •other inflammatory conditions;
- •major diabetic complications such as retinopathy, nephropathy, neuropathy and atherosclerosis.
研究组 & 干预措施
chronic periodontitis
Non-surgical periodontal therapy.
干预措施: Non-surgical periodontal therapy (Procedure)
Chronic periodontitis + type 2 diabetes
Non-surgical periodontal therapy + systemic doxycycline non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before first scaling and root planning session.
干预措施: non-surgical periodontal therapy + systemic doxycycline (Drug)
结局指标
主要结局
clinical attachment level
时间窗: baseline and two months
relative clinical attachment level (rCAL) was recorded at six sites per tooth with the aid of a computerized periodontal probe.
次要结局
- Gene expression(Two months)
- Salivary proteins levels(baseline and two months)
研究者
Priscila Paganini Costa
PhD
University of Sao Paulo