Impact of Periodontal Treatment on Serum Levels of Hepcidin and Hemoglobin: a Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Changes in Hepcidin serum level after periodontal treatment as assessed by ELISA.
研究概览
简要总结
Periodontitis is an inflammatory/infectious disease of high prevalence in the population and which has been linked to several chronic inflammatory systemic diseases. However, few studies have evaluated the periodontal disease in the absence of other inflammatory conditions stimulate inflammatory markers as C-reactive protein (CRP), Interleukin - 6 (IL-6) hepcidin and hemoglobin. The aim of this study was to evaluate the influence of nonsurgical periodontal therapy on the change of inflammatory markers and anemia in control subjects and patients with chronic periodontitis after three months.This interventional study included 67 individuals of both sexes, aged 30-65 years, without other diseases, except chronic periodontitis, with at least 20 teeth, selected from a total 125 individuals following the eligibility criteria. Periodontal clinical parameters (probing depth, bleeding on probing, clinical attachment level) and systemic, hematological as well as inflammatory markers CRP, IL-6 and hepcidin were compared before and after nonsurgical periodontal therapy by serum and plasma examination of control individuals and patients with chronic periodontitis.
详细描述
It conducted a non-randomized intervention study from April to October 2013, with individuals in the periodontics clinics of the Federal University of Maranhão State, São Luís, Brazil. The sample was selected from a total of 125 individuals, according to the eligibility criteria. Two groups were formed: experimental group (33 individuals) healthy patients except for the presence of chronic periodontitis in the advanced stage, and control group (30 subjects) patients without systemic disease proven by physical and biochemistry examination, and without chronic periodontitis.
The study was approved by the Ethics Committee on Human Research of the Federal University of Maranhão, São Luís, MA, Brazil under the protocol number 23115-010215 / 2011-16. All participants signed the consent form.
The sample size was defined on the basis of previous studies on the association between chronic periodontitis and systemic inflammatory markers.
All participants received an oral hygiene kit, attended a motivational speech with instructions on tooth brushing and flossing, and they were later referred for dental care.
At first visit, the medical record was checked for selecting volunteers without pre-diagnosed systemic diseases, in addition the general and periodontal clinical examination were performed, the urine collector was delivered, and drug intake [Albendazole 400 mg as a single dose]. After 15 days, subjects who met the initial selection criteria were sent for blood and urine collection for evaluation of biochemical markers. According to the results of laboratory tests, subjects were maintained or excluded after verification of those diagnosed with systemic diseases not previously identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes
- •Aged 30-65 years
- •Without other chronic systemic diseases except periodontitis
- •At least 20 teeth
排除标准
- •Diabetes mellitus
- •Congestive heart failure
- •Chronic kidney disease
- •Malignant neoplasms
- •Acquired immunodeficiency syndrome
- •Hypertension
- •Pregnant women
- •Nursing mothers
- •Immunosuppressed by medication
- •Women with changes in menstrual flow
- •Smokers or ex-smokers for less than 10 years
- •Usage history of NSAIDs or nonsteroidal and antibiotics within 3 months prior to the study and during the search
- •Iron replacement in patients to treat anemia and carrying out subgingival scaling and periodontal surgery in 6 months prior to investigation.
研究组 & 干预措施
Periodontal Treatment
The experimental group underwent nonsurgical periodontal therapy, performed by a single professional who performed the scaling and root planing procedures under local anesthesia using an ultrasonic device and Gracey and mini Gracey curettes, with Robson polishing brush and prophylactic paste. This therapy was performed in two sessions at seven day intervals, with no time limit, according to the needs of each periodontal condition. In each session, subjects received oral hygiene instruction (OHI) for use of toothbrushes for the modified Bass technique, dental floss and other complementary means (interdental brush, single tuft brush, electric toothbrush, etc.) when necessary. Supportive periodontal therapy was performed in 30, 60 and 90 days. Albendazole administration.
干预措施: Periodontal Treatment (Procedure)
Periodontal Treatment
The experimental group underwent nonsurgical periodontal therapy, performed by a single professional who performed the scaling and root planing procedures under local anesthesia using an ultrasonic device and Gracey and mini Gracey curettes, with Robson polishing brush and prophylactic paste. This therapy was performed in two sessions at seven day intervals, with no time limit, according to the needs of each periodontal condition. In each session, subjects received oral hygiene instruction (OHI) for use of toothbrushes for the modified Bass technique, dental floss and other complementary means (interdental brush, single tuft brush, electric toothbrush, etc.) when necessary. Supportive periodontal therapy was performed in 30, 60 and 90 days. Albendazole administration.
干预措施: Albendazole (Drug)
结局指标
主要结局
Changes in Hepcidin serum level after periodontal treatment as assessed by ELISA.
时间窗: 90 days
次要结局
- Changes in periodontal outcomes (Probing depth in millimeters and clinical attachment level in millimeter) after periodontal treatment.(90 days)
- Percentage of sites with visible plaque and /or bleeding on probing after periodontal treatment.(90 days)
- Changes in us-CRP serum level after periodontal treatment as assessed by ELISA.(90 days)
- Changes in Interleukin 6 serum level after periodontal treatment as assessed by ELISA.(90 days)
研究者
Sandra Augusta de Moura Leite
Professor in Federal University of Maranhao
Federal University of Maranhao