Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Implant success rate according to Buser's criteria
研究概览
简要总结
The main aim of the present study is to investigate implant success rate after 5 years of function of immediate (Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement) loading of two-pieces zirconia implant, placed in pristine bone without bone regeneration. Implant success rate will be defined according to Buser's criteria. Secondary endpoints: Marginal bone level (MBL) evaluation by means of standardized radiographs; Clinical evaluation of biological (e.g. Plaque Index, PI; Probing Pocket Depth, PPD, Bleeding on Probing, BOP; suppuration upon probing/palpation) and prosthetic/technical complications; Clinical evaluation of soft tissue width, keratinized tissue, marginal and interproximal soft tissue recession; Patient reported outcome measures (PROMs) by questionnaire administration:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sistemically healthy patients
- •partial edentulism
- •premolar position
- •molar position
- •Bone width and height at least 6 and 10mm, respectively.
- •Keratinized tissue, at least 1 mm at implant site
- •Full understanding of the proposed surgical treatments and the protocol schedule
- •Full comprehension and availability to sign the informed consent form
排除标准
- •Heavy smokers (>10 cigarettes a day)
- •Serious kidney or liver diseases
- •Uncontrolled diabetes
- •Bisphosphonates intake
- •History of radiotherapy of the head and neck
- •Current antiblastic chemotherapy
- •Congenital (primary) or acquired (secondary) immunodeficiency
- •Pregnant women
- •Connective tissue disorders
- •Local exclusion criteria:
- •untreated stage III/IV periodontitis
- •Autoimmune diseases
- •oral parafunctions
研究组 & 干预措施
Immediate loading zirconia implant
Loading of zirconia dental implant within 7 days after implant placement
干预措施: Zirconia implant (Device)
Delayed loading zirconia implant
Loading of zirconia dental implants after at least 2 months of healing
干预措施: Zirconia implant (Device)
结局指标
主要结局
Implant success rate according to Buser's criteria
时间窗: 5 years
presence of subjective complaints related to the area of treatment; recurrent infections in the peri-implant region accompanied by suppuration; mobility of the implant fixture
次要结局
未报告次要终点
研究者
Antonino Palazzolo
Dr. Principal Investigator
University of Milan