Evaluation of the Marginal Bone Level of Titanium Implants Produced by Additive Manufacture, in 30 and 90 Days: Randomized Within-subject Clinical Trial of 1-year Non-inferiority
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Marginal Bone Loss (MBL)
研究概览
简要总结
The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up
详细描述
This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year
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 (Care Provider, Outcomes Assessor)
盲法说明
either the operator or the patient will be blinded for the primary outcome
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
- •Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo;
- •Individuals over 18 years and under 70 years of age;
- •Good general health;
- •signed Informed Consent Form;
- •Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars);
- •bacterial plaque index ≤ 20% (Silness & Loe, 1964);
- •bleeding rate of ≤ 20% (Loe & Silness, 1963);
- •Sufficient alveolar bone volume for an implant of:
- •Length: 8 or 10mm
- •Diameter: 3.5mm,
- •Bone quality type I-III;
- •No associated bone regeneration.
排除标准
- •Pregnant and lactating women;
- •Uncontrolled diabetes;
- •History of chemotherapy or radiotherapy in the last 5 years;
- •Radiotherapy in areas of the head and neck;
- •Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids;
- •Alcohol or drug abuse;
- •Untreated periodontitis;
- •History of previous bone increase in the implant installation region;
- •Presence of residual roots at the site receiving the implant;
- •Bone density type IV
- •Individuals with connective tissue disorders or metabolic diseases;
- •Postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism;
- •Need for guided bone regeneration at the time of implant installation.
研究组 & 干预措施
Loading in 30 days
Implant allocated to the study arm will be restored with a temporary restoration after 30 days of implant placement, that will be replaced with definitive restoration after 90 days of implant placement.
干预措施: Dental implant produced by additive manufacture (Device)
Loading in 90 days
Implant allocated to the study arm will be restored directly with the definitive restoration after 90 days of implant placement.
干预措施: Dental implant produced by additive manufacture (Device)
结局指标
主要结局
Marginal Bone Loss (MBL)
时间窗: 1 year
Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.
次要结局
- Implant success rate(1 year)
- Modified Bleeding Index (mBI)(1 year)
- Modified Plaque Index (mPI)(1 year)
- Pocket probing depth (PPD)(1 year)
- clinical attachment level (CAL)(1 year)
研究者
Giuseppe Alexandre Romito
Professor
University of Sao Paulo