The Effect of Periodontal Treatment on Quality of Life in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 158
- 试验地点
- 4
- 主要终点
- Changes at glycated hemoglobin.
研究概览
简要总结
The aim of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome. There will be a randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last six months , and after this period, the control group will receive the same treatment to the test group . A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history . Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment . In addition to the tests required for the diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein). Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at baseline and after 6 months of the study . The primary outcome will be change in glycated hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive protein.The hypothesis of this study considers that periodontal treatment can alter the serum levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with metabolic syndrome and thereby contribute to improved quality of life. The objective of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome.
详细描述
There will be a randomized clinical trial with patients from the outpatient clinic of Endocrinology - Prediabetes and outpatient dental clinic of the Faculty of Dentistry, UFRGS who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last for six months , and after this period, the control group will receive the same treatment to the test group .
A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history. A questionnaire with some key questions will be repeated in 10 % of the sample within seven days after the first application in order to check the reproducibility of the instrument.
Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment. The examination will be conducted by two examiners trained and calibrated. There will be measured Probing Depth , Bleeding On Probing, Periodontal Attachment Loss , Gingival Bleeding Index , Visible Plaque Index and the retentive factors of plaque.
In addition to the tests required for the diagnosis of metabolic syndrome , will be did the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein) . Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, TNF- α , GLP-1 and adiponectin .
At each clinical examination will be collected gingival crevicular fluid , and subgingival biofilm above 4 sites randomized among those with higher probing depth at baseline. The sites of fluid collection will be properly insulated with cotton rolls and / or gauze and dried with air jets . From the introduction of rectangles of absorbent paper (Periopaper ) for 30 seconds will be held in the gingival sulcus fluid collection . Periopaper strips are analyzed for volume (Periotron 8000) and stored in sterile plastic tube at -80 ° C until analysis. The presence of Il- 1β , IL-6 and TNF- α in the gingival fluid will be identified by flow cytometry .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •older than or equal to 18
- •at least 10 teeth
- •diagnosis of periodontitis ( > 2 interproximal sites with PD> 5 mm in distinct teeth or > 2 interproximal sites with PI > 4mm in different teeth of according to Page and Eke , 2007)
- •have metabolic syndrome (The patient must present at least among the following three criteria: (a ) waist circumference greater than 90 inches for men and for women over 80 , (b) triglycerides ≥ 150 mg / dl ( 1.7 mmol / L ) or as a treatment for hypertriglyceridemia (c ) HDL cholesterol less than 40 mg / dL for men and less than 50 mg / dl for women or being treated for dyslipidemia ; ( d ) hypertension at examination ( systolic ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg ) or hypertension diagnosis or past history or treatment for hypertension , (e ) plasma glucose ≥ 100 mg / dl or a diagnosis of diabetes or use of medication for glycemic control)
排除标准
- •have periodontal treatment performed in the last six months
- •have used antibiotics in the last 3 months
- •have indication of antibiotic prophylaxis for dental care
- •be pregnant
- •chronic use of systemic corticosteroids
结局指标
主要结局
Changes at glycated hemoglobin.
时间窗: This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment.
Glycated hemoglobin will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control)
次要结局
- Changes at Protein C reactive and serum fibrinogen.(These outcomes will be measured at 0, 3 and 6 months after periodontal treatment.)
研究者
Patricia Weidlich
Patricia Weidlich
Federal University of Rio Grande do Sul