Biting Force and Quality of Life in Porcelain-fused-to Metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II ( In Vivo Study )
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Evaluation of biting force
研究概览
简要总结
The goal of this randomized clinical trial is to compare biting force and patient satisfaction in three groups. Patients in the control group number one will receive a CoCr removable partial denture, and in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area. After three months, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Biting force will be measured bilaterally at the time of delivery of the removable partial denture and delivery of fixed partial dentures after two, four, and six months. Patient satisfaction will be assessed through a quality-of life questionnaire at the six-months recall appointment
详细描述
Thirty-three partially edentulous patients will be recruited. Patients will be randomly divided into three groups. Patients in the control group number one will receive a CoCr removable partial denture; in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. Pre-surgical and post-surgical prescription of antibiotics, anti-inflammatory drugs, analgesic drugs, and mouthwash for one week, then a follow-up will be done at the suture removal appointment. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Recall appointments will be scheduled for the patients two, four, and six months after loading for the collection of the data. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at the loading of implants after two, four, and six months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the six-months recall appointment.
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kennedy Class II mandibular arch where the last standing abutment is the first premolar, opposed by a fully dentate maxilla (either natural dentition or fixed prostheses).
- •A minimum of 12 millimeters of bone height above the inferior alveolar canal diagnosed from the pre-operative cone beam CT.
- •Sufficient inter-arch space to accommodate the implant supported fixed partial denture.
排除标准
- •Patients with bone or mucosal diseases.
- •Heavy smokers.
- •Patients with uncontrolled metabolic disorders such as diabetes mellitus.
- •Patients with parafunctional habits.
- •Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
结局指标
主要结局
Evaluation of biting force
时间窗: Biting force will be measured by newtons unit per minute using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months.
improvement of Biting force in two different implants supported partial dentures.
次要结局
- Oral health-related quality of life ( OHRQoL ) Measurement(At the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the recall appointments.)