Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Technical & Biological Outcomes
研究概览
简要总结
To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant.
To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions.
First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns.
Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns.
详细描述
Study design:
A short-randomized controlled trial study, the (PICO) study design: population will be patients from Jordan University Hospital with implants planned for single screw-retained zirconia crowns in the posterior site (premolar or molar), intervention will be the multilayer monolithic screw-retained zirconia crowns over implants, the comparator is the conventional monolithic zirconia crowns over implants, and the main outcomes will be the prosthetic/technical outcomes, survival and success rates in addition to radiographic, patient-reported outcomes, and biological parameters.
Methodology The patients who fulfilled the inclusion/exclusion criteria and entered the study will have a fully digital workflow starting from data acquisition using an intraoral scanner (3Shape TRIOS® 5) , Ti-base abutment design and CAD/CAM milling of the two types of monolithic zirconia blanks (IPS e.max® ZirCAD Prime and IPS e.max® ZirCAD LT).
The fabricated zirconia crowns in both groups will have the same treatment and will be cemented to the Ti-base abutment according to the (APC) concept; alumina airborne-particle abrasion 50-μm at 1 bar for 15-20 seconds, intaglio surface primed using MDP for 60 seconds and air blown for 5 seconds, and finally cemented to the abutment by phosphate monomer resin cement PANAVIA™ V5(Blatz-Alvarez-Compendium-APC-2016, n.d.).
On the other hand, the Ti-base abutment: height will be standardized at 4mm, and the base abutment surface will have blasting with alumina particles of 50 μm at 2-bar pressure for 15-20 seconds at a 10-mm step-over distance at an angle of 45 degrees.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially edentulous area with suitable restorative space more than 5.5 mm
- •At least 18 years of age
- •Opposing natural teeth or fixed restorations supported by teeth or implants.
- •Generally good health (ASA I, ASA II)
- •Participant complies with good oral hygiene practices (BOP and PI less than 20%)
- •Healthy integrated implant/s without signs of periimplantitis in the posterior site planned for single tooth replacement (in premolar or molar areas)
- •Patients received bone-level implants, RC Straumann Implants.
排除标准
- •Inability to provide consent.
- •Temporomandibular disorders
- •Smoking of more than 10 cigarettes per day
- •Untreated caries or periodontal disease of remaining dentition
结局指标
主要结局
Technical & Biological Outcomes
时间窗: Baseline, 6 months, 12 months
The abutments and restoration will be evaluated clinically by two blinded investigators, according to the modified United States Public Health Service (USPHS) criteria USPHS criteria involve four Scales: Alpha, Bravo, Charlie, Delta The criteria of evaluation include: Restoration fracture, Abutment Fracture, Loosening of the restoration, Screw-access hole restoration, Occlusal Wear, Anatomical Form, Color match, Proximal contact, Occlusal Contact, Marginal Fit, Periodontal parameters.
Patient reported outcomes
时间窗: 6 months, 12 months
Patient satisfaction in terms of the shape and shade of the crown, their ability to chew (function) and floss (proximal contact) and their overall satisfaction with the restoration provided will be assessed by a questionnaire based on a five-grade ordinal category scale (extremely satisfied, satisfied, neutral, dissatisfied and extremely dissatisfied). Each patient was asked to fill out the questionnaire themselves to ensure as little bias as possible.
Survival and Success rate
时间窗: 6 months, 12 months
All patients will be evaluated for success and survival of restorations at 6 months and 1 year after placement of the restorations (Follow-ups). The success rate is defined as the number of restorations that did not change over time. The survival rate is defined as the number of restorations that did not require replacement.
次要结局
未报告次要终点
研究者
Susan Hattar
Professor
University of Jordan