Assessment of Peri-Implant Tissues Surrounding PEEK and Porcelain Fused to Metal Superstructures in Posterior Region (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Visual analogue scales (VAS) for measuring the patient satisfaction
研究概览
简要总结
The purpose of this study is to evaluate the influence of two superstructure materials Porcelain Fused to Metal (PFM) and PEEK on peri- implant soft and hard tissue reaction clinically.
详细描述
Nowadays the use of dental implants for restoring missing teeth has gained a wide acceptance, due to its high success rate.
Dental implants differ from natural teeth in transmission of functional loads to the bone, where natural teeth and their periodontal ligaments provide proprioception, early detection of occlusal loads and have a shock-absorbing function. Sensitivity and mobility of natural teeth cannot be duplicated in osseointegrated implants,1 therefore most of the forces are concentrated at the crest of the ridge leading to different living reaction including bone resorption and subsequent implant loss.
Minimizing the occlusal loads on osseointegrated implants through selection of a new superstructure material that can absorb part of this excessive force could be believed to be a determining factor in the long-term success of an implant treatment program.
Many restorative materials are used nowadays for construction of final restoration of implant supported superstructures including porcelain fused to metal (PFM), all ceramic, zirconia, hybrid ceramics, and polyetheretherketone (PEEK). PFM restorations are still considered as the gold standard because of their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation. Recently, the use of new resilient superstructure material like PEEK-based restoration on implant prosthetics could modify the occlusal forces with subsequent cushioning during function.
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)
盲法说明
Double blind (Patients and outcome assessors) both patient and assessor will be blinded to the assigned material. However the operator can't be blinded due to the difference in preparation and shade of the ceramic materials. Reem Gabr will be responsible for the try-in and final delivery of the crowns.
-The assessor will assess all outcomes blinded to the material assigned for each patient.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
porcelain fused to metal crown
Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
干预措施: PEEK crown (Other)
porcelain fused to metal crown
Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
干预措施: PFM Crown (Other)
PEEK crown
The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading
干预措施: PEEK crown (Other)
PEEK crown
The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading
干预措施: PFM Crown (Other)
结局指标
主要结局
Visual analogue scales (VAS) for measuring the patient satisfaction
时间窗: 12 months
Visual analogue scales will be used before the treatment and at the follow-ups to record and evaluate subjective patient's perceptions including the appraisal of function eating, esthetics, sense, speech, and self-esteem. The patients were asked to mark their subjective perception in each category on a horizontal line (100 mm in length), 1 mm (the minimum score) corresponded to 1% of satisfaction and 100 mm (the maximum score) corresponded to 100% of satisfaction.
次要结局
- Gingival index(12 months)
- bleeding index(12 months)
- Crestal bone loss(12 months)
- Probing depth(12 months)
研究者
Reem Mohamed Ali Gabr
doctor
Cairo University