Comparison of Electromyographic Muscle Activity and Occlusal Accuracy Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
研究概览
简要总结
A within-subject cross-over study is done on eight completely edentulous patients to compare two different complete removable dentures. Group I: Heat cured Conventional complete dentures designed based on the neutral zone concept; Group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. Occlusal analysis is done by the T-Scan device, and evaluation of muscle activity is conducted by electromyography at insertion time, two weeks after insertion time, and one month after insertion time.
详细描述
This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: Heat cured Conventional complete dentures designed based on the neutral zone concept, group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. The study will be carried out on eight completely edentulous patients, each patient will receive two sets of complete dentures in a random sequence. For each denture set, at the denture insertion visit occlusal analysis and equilibration will be performed with the aid of the T-Scan device, also EMG evaluation of muscle activity will be conducted. Two weeks after, the patients will be recalled to reanalyze the occlusion after the denture settles using the T-scan computerized system. One month after the last recall visit, the EMG evaluation of muscle activity will be conducted again. The EMG and T-scan recording data will be collected and analyzed to compare the two denture types
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
- •Patients with a resorbed mandibular ridge.
- •Patients with a Class I maxillo-mandibular relationship
- •Patients with adequate inter-arch space.
- •Patients with good neuromuscular control.
- •Patients without any tempo-mandibular disorder.
排除标准
- •Patients with any oral diseases that may affect complete denture construction
- •Patients with bad oral hygiene.
- •Patients with neuromuscular disorders.
- •Patients with a history of parafunctional habits.
- •Hysterical patients.
- •Patients will undergo or have previously received chemotherapy or radiotherapy.
- •Drug-addicted patients.
研究组 & 干预措施
Heat Cured Conventional Complete Removable Dentures based on neutral zone concept
The patient will be provided by a complete removable denture designed based on the neutral zone concept to restore his missing teeth which will be manufactured by heat curing of Polymethyl methacrylate.
干预措施: Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept (Device)
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
干预措施: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. (Device)
结局指标
主要结局
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
时间窗: one month
The electromyography activity of the Masseter and Temporalis muscles will be evaluated during clenching, chewing of soft food, and chewing of hard food, at the time of denture insertion (baseline) and one month after baseline.The measuring unit is mv.
次要结局
- Evaluation of occlusal force equilibration using t-scan device(two weeks)
研究者
Omnia M. Refai
Lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, Ain Shams Univeristy
Ain Shams University