Patient Satisfaction, Peri-implant Parameters and Crestal Bone Evaluation of PEEK (Polyetheretherketone) Abutments Versus Zirconium Abutments Restored With PEEK Based Superstructure: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- change in Patients satisfaction: VAS
研究概览
简要总结
The aim of the study is to evaluate the patients' satisfaction, peri-implant parameters (bleeding on probing, probing depth and plaque index) and crestal bone resorption of implants restored with PEEK abutments restored with PEEK superstructure compared to implants restored with zirconia abutments with PEEK superstructure.the NULL HYPOTHESIS;There is no difference between the two groups
详细描述
Trial design:
Randomized Controlled Trial., Parallel Design., Allocation ratio 1:1
This study will be carried out on patients enrolled from the Outpatient clinic in the Fixed Prosthodontics clinic, Faculty of Dentistry, Cairo University.
First Visit: ( Diagnosis and records Making)
Patients will be recalled to the outpatient clinic, treatment will be discussed with the patient in details with the expected timeline and full duration of the treatment and a signed consent will be obtained from the patient.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients above 18 years old
- •Patients able to read and sign the informed consent.
- •Medically free patients or with controlled systemic condition.
- •Missing tooth/teeth in the esthetic zone
- •Minimum bucco-lingual bone width of 6mm, evaluated using CBCT.
- •Good oral hygiene and favourable occlusion
- •Cooperative and motivated Patients.
排除标准
- •Under 18 years old
- •Illiterate, unable of comprehending or signing the informed consent form
- •Uncontrolled systemic disease (e.g. Diabetes or hypertension) or debilitated health condition
- •Poor oral hygiene or unfavorable occlusion
- •Uncooperative, not willing to return for follow up visits
- •Insufficient bone quantity or quality for implant placement
研究组 & 干预措施
PEEK abutment
PEEK abutment restored with PEEK superstructure
干预措施: PEEK implant abutment (Device)
Zirconia abutment
zirconia abutment restored with PEEK superstructure
干预措施: Zirconia abutment (Device)
结局指标
主要结局
change in Patients satisfaction: VAS
时间窗: baseline, 3, 6 and 12 months (1 year)
Visual analogue scale (VAS) a numerical scale from 0 - 10 , 0 = not satisfied and 10 = highly satisfied
次要结局
- Change in bleeding in probing(baseline, 3 , 6 and 12 months (1 year))
- Change in periodontal probing depth(baseline, 3 , 6 and 12 months (1 year))
- Change in Plaque accumilation(baseline, 3 , 6 and 12 months (1 year))
研究者
Amr Ali youssef
Assistant lecturer
Cairo University