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
- 1
- 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
研究组 & 干预措施
Full preparation
Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.
干预措施: Implant bed preparation protocol (Procedure)
Partial preparation
Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.
干预措施: Implant bed preparation protocol (Procedure)
Deferred loading
Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load.
干预措施: Implant loading (Procedure)
Immediate load
The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load.
干预措施: Implant loading (Procedure)
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