Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam - A Study of Patients Examined at the Dental Biomaterials Adverse Reaction Unit in 1993 to 1999
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of subjective health complaints
研究概览
简要总结
The aim of the project is to study changes in symptom load after removal of all dental amalgam restorations in patients with symptoms allegedly related to amalgam.
详细描述
Patients referred from dentists and physicians in the period 1993 to 1999 to the Dental Biomaterials Adverse Reaction Unit, Department of Health, UNIFOB AS, for symptoms related to amalgam restorations are randomized into treatment group (n=20) or reference group (n=20). All patients in the treatment group are followed 3, 12, 36 and 60 months after completion of amalgam removal with questionnaires on health outcomes, Minnesota Multiphasic Personality Inventory-2 (MMPI-2) and laboratory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for examination of general health complaints related to amalgam
- •Health complaints from at least three different organ systems
- •Dental amalgam restorations present
- •Data available on concentration of mercury in blood and urine at the initial examination
- •Patient agreed to be contacted after the examination
排除标准
- •Serious disease (incl. severe allergy to foodstuff and severe rheumatoid arthritis)
- •Mental instability or psychiatric disease
- •Cases with complicated dental rehabilitation (incl. bridge prostheses)
- •Allergy to dental replacement materials
- •Severe periodontitis
- •High caries activity
结局指标
主要结局
Changes of subjective health complaints
时间窗: Five years
Changes over time of the MMPI-profile
时间窗: Five years
Quality of life improvement
时间窗: Five years
次要结局
- Reduction of mercury in blood serum(One year)
研究者
Lars Bjorkman
Principal Researcher
NORCE Norwegian Research Centre AS