Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Changes in the levels of MDA in dental patients GCF after the applied treatments
研究概览
简要总结
The goal of the study was to ascertain the influence of dental caries and teeth position as well as the type and amount of the applied dental materials (DMs) on the oxidative stress (OS) status in gingival crevicular fluid (GCF).
详细描述
Six DMs were tested by investigators, each sealed in one session: amalgam (Amg), zinc phosphate cement (ZnPhC), zinc polycarboxylate cement (ZnPoC), glass ionomer cement (GIC) and composites, Tetric EvoCeram (TEC) and Beautifil (BF).
The study included 88 dental outpatients. Oxidative stress parameters, including malondialdehyde (MDA), glutathione (GSH) and total superoxide dismutase (tSOD) activity were measured in GCF, before (day 0) and after treatment (7th and 30th day).
Antagonistically positioned healthy teeth were used as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria related to the condition of teeth:
- •Presence of proximal caries on anterior and posterior teeth
- •Existence of the antagonistic tooth ("mirror"-positioned healthy tooth) to be used as control
- •An absence of fresh post-extraction or traumatic wounds in the restoration area or in the area of restored surfaces
- •An absence of infection in the area of restored surfaces
- •Other influencing criteria:
- •Absence of bone-associated diseases or treatments
- •Satisfactory oral hygiene
- •Patients exhibiting good compliance
排除标准
- •Criteria related to the condition of teeth:
- •Endodontic and/or periodontal infections in the area of the cervical filling
- •Presence of periodontopathy
- •Prominent periodontal pockets
- •Subgingival carries
- •Prominent fillings outside the cavity
- •Other influencing criteria:
- •Patients on radiation or immunosuppressive therapy
- •Presence of bone-associated diseases and malignant diseases
- •Patients using drugs/alcohol/cigarettes (> 20 cigarettes per day)
- •Bad oral hygiene
- •Patients exhibiting poor compliance
研究组 & 干预措施
Amalgam (Amg)
Amalgam was sealed in 8-K2 patients and 6-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Amalgam placement (Procedure)
Tetric EvoCeram (TEC)
Tetric EvoCeram was sealed in 12-K2 patients and 5-K5 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Tetric EvoCeram placement (Procedure)
Beautifil (BF)
Beautifil was sealed in 15-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Beautifil placement (Procedure)
Zinc phosphate cement (ZPhC)
Zinc phosphate cement was sealed in 7-K2 patients, 4-K3 patients, 1-K4 patients and 2-K5 patients.
Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Zinc phosphate cement placement (Procedure)
Zinc polycarboxylate cement (ZPoC)
Zinc polycarboxylate cement was sealed in 5-K2 patients, 4-K3 patients and 5-K4 patients.
Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Zinc polycarboxylate cement placement (Procedure)
Glass ionomer cement (GIC)
Glass ionomer cement was sealed in 11-K2 patients, 2-K3 patients and 1-K5 patients.
Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
干预措施: Glass ionomer cement placement (Procedure)
结局指标
主要结局
Changes in the levels of MDA in dental patients GCF after the applied treatments
时间窗: 0th, 7th and 30th days.
The concentration of MDA in GCF was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.
次要结局
- Changes in the levels of GSH in dental patients GCF after the applied treatments(0th, 7th and 30th days.)
研究者
Ervin Taso
Principal Investigator
Military Medical Academy, Belgrade, Serbia