Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
研究概览
简要总结
The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.
详细描述
All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.
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
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
- •Patients ages 20-45 y.o.
排除标准
- •Chronical third-degree cardiac failure
- •Connective tissue diseases
- •Decompensated diabetes
- •Neoplastic processes
研究组 & 干预措施
ASTRA TECH implants
implant restoration(replace of a missing tooth) - 35 patients
干预措施: EMG befor denture treatment (Procedure)
ASTRA TECH implants
implant restoration(replace of a missing tooth) - 35 patients
干预措施: EMG in a month after termination of treatment (Procedure)
ASTRA TECH implants
implant restoration(replace of a missing tooth) - 35 patients
干预措施: EMG in a 3 months after termination of treatment (Procedure)
CROWN
to fixed denture restorations in own teeth - 32 patients
干预措施: EMG in a month after termination of treatment (Procedure)
CROWN
to fixed denture restorations in own teeth - 32 patients
干预措施: EMG in a 3 months after termination of treatment (Procedure)
CROWN
to fixed denture restorations in own teeth - 32 patients
干预措施: EMG befor denture treatment (Procedure)
non-edontulos
control group will consist 38 non-edotulos patients
干预措施: EMG befor denture treatment (Procedure)
结局指标
主要结局
The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
时间窗: up to 3 months.
The present study demonstrated that Osseo Speed implants are safe and reasonable way of treatment for partial tooth loss in the lateral side. There was observed healthy soft tissue and marginal bone stability around the implants. Received data analysis using surface EMG allow to assume than functional state of maxillofacial region and neuromuscular coordination of the muscles of mastication in patients with bounded edentulous space in the lateral side (molars and/or premolars) with implant-supported prosthesis is considerably better than in patients with fixed bridges. Implant-supported prosthesis provide greater bite force for chewing function in comparison with fixed bridges , but certainly less effective than natural teeth. Implant-supported prosthesis increase patients' quality of life and is more convenient for dentoalveolar apparatus.
次要结局
未报告次要终点
研究者
Silin Alexey Viktorovich
Principal Investigator
North-Western State Medical University named after I.I.Mechnikov