Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Clinical periodontal parameters / clinical attachment level (CAL)
研究概览
简要总结
The aim of this randomized, single-masked, controlled clinical trial study was to determine if the administration of electro acupuncture improves the outcomes obtained in combination with non-surgical periodontal therapy.
Participants will get non-surgical periodontal therap with/without electro acupuncture.
Researchers will compare EA and control groups to see if there is any relationship between acupuncture application clinical periodontal parameters,serum and saliva cytokine levels.
详细描述
Periodontitis is a prevalent complex chronic inflammatory oral disease that can result in the progressive destruction of tooth supporting tissues and eventual loss of teeth. Although pathogenic bacteria are the triggers and provokers of periodontal inflammation, the main determinant of the destruction is the host immunoinflammatory response. The host response is modified by many genetic and environmental factors as well as various systemic diseases.
Electroacupuncture (EA) has effects on both the immune system and inflammatory processes. The effect of acupuncture on the regulation of cytokine production has been mentioned in the literature. .
No study has been found in the literature about the effects of EA on the host modulation in periodontitis patients. In this study, the investigators aimed to examine the effect of electroacupuncture application on the host modulation at periodontitis.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •absence of any systemic disease,
- •pregnancy or breast feeding;
- •not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;
排除标准
- •Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
- •pregnant/breastfeeding
- •medication for any reason
- •smoker/tobacco user
- •other periodontal disease other than periodontitis
- •chronic inflammatory disease (COPD, asthma)
结局指标
主要结局
Clinical periodontal parameters / clinical attachment level (CAL)
时间窗: Baseline-week 3
CAL was measured as the distance between the deepest point of the sulcus and the cemento-enamel junction
Clinical periodontal parameters / probing pocket depth (PPD)
时间窗: Baseline-week 3
PPD was measured as the distance between the deepest point of the sulcus and the gingival margin
Clinical periodontal parameters / bleeding on probing (BOP)
时间窗: Baseline-week 3
The presence of bleeding on probing is considered an objective sign of periodontal inflammation
Clinical periodontal parameters / plaque index (PI)
时间窗: Baseline-week 3
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system
Clinical periodontal parameters / gingival index (GI)
时间窗: Baseline-week 3
The presence and extent of gingival inflammation and bleeding were graded according to the gingival index system
Biochemical findings
时间窗: Baseline-day 7-week 3
IL-6, IL-10, TNF-α
次要结局
未报告次要终点
研究者
Didem OZKAL EMINOGLU
assistant professor
Ataturk University