Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Marginal bone loss
研究概览
简要总结
2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values<0.05 were considered statistically significant
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 (Investigator, 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
- •Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.
排除标准
- •1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity
研究组 & 干预措施
Experimental Group
Two piece zirconia dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.
干预措施: Dental Implant (Device)
Control Group
Two piece titanium dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.
干预措施: Dental Implant (Device)
结局指标
主要结局
Marginal bone loss
时间窗: 4 month after T0
measure bone level from T0 baseline to T3
IL1b concentration
时间窗: 4 month
Measure IL fluid at T0 and T2 for IL1b characterization
IL6 concentration
时间窗: 4 month
Measure IL fluid at T0 and T2 for IL1b characterization
Osseointegration
时间窗: from T0 to T2 - 2 month
measure if the healing process of bone was successful
Microbiologic samples
时间窗: 4 month
Measure crevicular fluid at T0 and T2 for bacteria characterization
次要结局
未报告次要终点
研究者
Andre Chen
DMD
Implantology Institute