Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Primary stability of implants and peri-implant tissues
研究概览
简要总结
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients without systemic pathology
- •Adult of age who agree to be part of the study and sign the informed consent.
- •Patients smoking less than 5 cigarettes / day,
- •Patients not being completely edentulous
- •Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
- •Area of mature bone healed at least 6 months post-extraction.
- •The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer.
- •The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N.
- •The placement of the implant must always be 4 mm below the future gingival margi
排除标准
- •Immunosuppressed patients
- •Aesthetic edentulous areas of 13-23 and 33-43
- •Smokers of more than 5 cigarettes
- •Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
- •Index of bleeding greater than 30%
- •Patients with less than 2 mm of keratinized gingiva
- •Implants with ISQ index <55
- •When a margin of 1 mm safety cannot be assumed to the inferior dental nerve
结局指标
主要结局
Primary stability of implants and peri-implant tissues
时间窗: 12 months
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol (n = 20) and with the preparation protocol with under-fresh (n = 20). We will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
次要结局
- Basal Peri-implant tissue level: implant stability(1 day)
- Basal Radiological Bone Implant level(1 day)
- Basal Peri-implant tissue level: probing depth(1 day)
- Radiological bone implant stability(6 weeks)
- Peri-implant tissue stability: probing depth(6 weeks)
- Peri-implant tissue stability: ISQ(6 weeks)
- Clinical tissue levels of definitive prostheses: probing depth(6 months)
- Clinical tissue levels of definitive prostheses: ISQ(6 months)
- Radiological tissue levels of definitive prostheses: bone implant level(6 months)
研究者
Mario Pérez Sayáns
Professor
University of Santiago de Compostela