Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework in Completely Edentulous Mandibular Arches. (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Prosthetic complications
研究概览
简要总结
Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients.
详细描述
Four implants will be placed in the edentulous mandible following all on four surgical protocol. After 3 months as a healing phase, a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants. Provisional restorations will be removed, and final impressions will be taken for each patient using addition silicon impression materials. Framework will be constructed using either Cobalt Chromium (Co-Cr) or Poly Ether Ether Ketone (PEEK) according to the randomization process. Jaw relation and try-in will be done to ensure the correct centric relation. Final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations. Occlusal adjustments will be done after the delivery and in the subsequent follow up visit. Prosthetic complications (primary outcome) and biological considerations (secondary outcome) will be measured every 3 months along the follow up period which is one year.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- •Patients aged from 50 to 70, 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-extractive sites, they must have been healed for at least 3-month 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.
- •Pregnancy or nursing.
- •Drug abusers.
- •Psychiatric problems or unrealistic expectations.
- •Patients with infection and or inflammation in the area intended for implant placement.
- •Patients participating in other studies, if the present protocol cannot be properly adhered to.
- •Patients with signs of hyperactive muscles.
结局指标
主要结局
Prosthetic complications
时间窗: one year
record any prosthetic problem that occurs during the follow up period (such as screw loosening, screw fracture, prosthesis fracture, ....etc.)
次要结局
- Biological considerations(one year)
研究者
Mohannad Alaa Eldin Samy
Assistant lecturer - Prosthodontic department - Cairo University
Cairo University