Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Crestal bone changes
研究概览
简要总结
This interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant difference between the two types of dental implants through 12 months after the definitive prosthetic loading
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients
- •The age range of 50 to 60 years old (average of 55).
- •moderately developed mandibular residual ridges, covered with healthy mucosa, firmly attached to the underling bone and with average mucosal thickness (2-3) mm.
- •At least 12 mm of vertical bone height in the mandible allowing for placement of a 10 mm implant (2 mm safety distance to inferior alveolar nerve).
- •Patients were selected with Angle class-I maxillomandibular relationship with sufficient inter-arch space (13-15mm
排除标准
- •Heavy smokers of more than 10 cigarettes a day
- •Poor oral hygiene.
- •Patients with temporomandibular joint disorders(TMD),
- •Patients suffered of xerostomia,
- •Patients exhibited Para-functional habits, or recent extractions were excluded.
- •Patients with systemic diseases that might affect bone quality or quantity, or retard healing of the surgical wounds were excluded.
- •Patients receiving intravenous forms of bisphosphonates.
- •Patients who have had radiation therapy to the head and neck region.
- •Patients with existing implants in the jaws
- •Patients with previous bone grafting in either the maxillary or mandibular jaws.
结局指标
主要结局
Crestal bone changes
时间窗: 12 months
Measuring the amount of marginal(crestal) bone changes either loss or gain around the dental implants using the cone beam computed tomography(CBCT) in millimeter scales about the original marginal bone height measured at the time of the visit of final (definitive) prosthetic loading. The positive(+ve) values mean an increase (gain) in the marginal bone height around the implants, the more the +ve value, the more the gain in the bone height which is the better outcome, while the negative (-ve) values mean decrease (loss) in the marginal bone height around the implants, the more the -ve value, the more loss in the bone height, which is the worse outcome.
次要结局
- Patients Satisfaction(12 months)
研究者
Mohammad Eissa Mohammad Irakky
Assistant Lecturer of oral and maxillofacial prosthodontics, faculty of dentistry , Benha University
Benha University