NCT07475507进行中（未招募）不适用
Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Marginal bone loss
研究概览
简要总结
A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous patients requesting a fixed, implant supported restoration.
- •Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial.
- •Implant sites must allow the placement of four implants.
- •Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- •In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study.
- •Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)
排除标准
- •Patients with poor oral hygiene and motivation.
- •Female patients taking any medical treatment for management of osteoporosis.
- •Drug abusers.
- •Psychiatric problems or unrealistic expectations.
- •Patients with active infection or inflammation in the planned implant area at the time of implant placement.
- •Immuno-compromised patients (Diabetic with HBA1C > 7 or patients undergoing chemo or radiotherapy or bisphosphonates)
研究组 & 干预措施
Titanium framework reinforced all on four prosthesis
Other
Active Comparator: Titanium reinforced fixed all-on-four prosthesis
干预措施: Titanium framework reinforced all on four prosthesis (Other)
PEEK framework reinforced all on four prosthesis
Other
干预措施: PEEK framework reinforced all on four prosthesis (Other)
结局指标
主要结局
Marginal bone loss
时间窗: 12 months at intervals (0,3,6,9and 12 months)
Marginal bone loss around each dental implant using parallel technique in digital periodical radiographs which will be measured in mm from the crestal bone level at the implant platform.
次要结局
- Bone density(12 months at intervals (0,3,6,9and 12 months))
研究者
Ahmed Mohamed Hamed Khalaf
Assistant lecturer of Prosthodontics
Cairo University
研究点 (1)
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