Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 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, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.
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 that are grounds for absolute contraindication
- •Older adults who agree to be part of the study and sign the informed consent
- •Consumption of tobacco less than 5 cigarettes / day
- •Do not be completely toothless
- •Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
- •Area of mature bone healed at least 6 months post-extraction.
- •Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long
排除标准
- •Immunosuppressed
- •Aesthetic edentulous areas of 13-23 and 33-43
- •Smokers of more than 5 cigarettes
- •Index of bleeding greater than 30%
- •Patients with less than 2 mm of keratinized gingiva
- •Implants with primary stability with ISQ <55
- •Implants with ISQ index <55 at 8 weeks
- •When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm
结局指标
主要结局
Primary stability of implants and peri-implant tissues
时间窗: 10 months
Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators 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(8 weeks)
- Peri-implant tissue stability: probing depth(8 weeks)
- Peri-implant tissue stability: ISQ(8 weeks)
研究者
Mario Pérez Sayáns
Professor Mario Perez Sayans MD, PhD (Principal investigator)
University of Santiago de Compostela