Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.
研究概览
简要总结
Excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. Therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Planned for treatment with implant-supported fixed suprastructure(s).
- •18 years of age or older.
排除标准
- •Opposing teeth of implant-supported fixed suprastructure(s) are restored with removable artificial teeth.
- •Patients categorized in the classes 3 or higher according to the ASA system for classification of physical status.
- •Use of occlusal splint, mandibular repositioning appliance or any other bruxism mitigating device during sleep.
- •Active periodontitis at the time of implant placement.
- •Known allergy to Grindcare® electrode material.
- •Patients with a pacemaker.
- •Swollen, infected or inflamed tissues or skin eruptions, e.g. phlebitis, varicose veins etc. in the placement area of the Grindcare® electrode.
- •Pregnant women will not be treated with dental implants. Pregnancy after placement of implants will not be a reason to stop participation of the subject in the study.
结局指标
主要结局
Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.
时间窗: Baseline, two weeks, six weeks, three months, one year, two years.
Changes in the modified Gingival Index during a two-year follow-up period, assessed by probing.
时间窗: Baseline, two weeks, six weeks, three months, one year, two years.
Changes in the peri-implant clinical pocket depth (in mm) during a two-year follow-up period, assessed by probing.
时间窗: Baseline, two weeks, six weeks, three months, one year, two years.
Changes in implant mobility (mobility present or not) during a two-year follow-up period, assessed by clinical examination.
时间窗: Baseline, two weeks, six weeks, three months, one year, two years.
Occurrence and type of implant technical complications, assessed by clinical examination.
时间窗: Six weeks, three months, one year, two years.
Changes in the peri-implant attachment level (in mm) during a two-year follow-up period, assessed by probing.
时间窗: Baseline, two weeks, six weeks, three months, one year, two years.
次要结局
未报告次要终点
研究者
Frank Lobbezoo
Prof. Dr.
Academic Centre for Dentistry in Amsterdam