3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- bone loss
研究概览
简要总结
Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.
The comparison between these two solutions will be evaluated in the trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper central incisor edentulism
- •bone width between 3.5-4.5 mm
- •requirement of only one implant supported crown
- •patient is willing to sign an informed consent
排除标准
- •General contraindications to implant surgery.
- •Immunosuppressed or immunocompromised patients
- •Patients irradiated in the head and neck area.
- •Patients with poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnancy or lactation.
- •Addiction to alcohol or drugs.
- •Untreated periodontal disease.
- •Treated or under treatment with intravenous amino-biphosphonates.
- •Poor oral hygiene and motivation.
- •Psychiatric problems and/or unrealistic expectations.
- •Acute infection (abscess) or suppuration in the area intended for implant placement.
- •Patients referred only for implant placement if cannot be followed at the treatment centre.
- •Patient unable to attend the follow-up controls for 3 years after implant loading.
- •Patient included in other studies, if this protocol cannot be properly followed.
- •Immediate post-extractive sites (to be eligible at least 3 months must have passed since extraction).
研究组 & 干预措施
Dental implant with bone augmentation
patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
干预措施: ICE dental implant 4.2 mm (Device)
Dental implant with bone augmentation
patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
干预措施: Alpha Bio's Graft Bovine bone (Device)
Dental implant with bone augmentation
patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation
干预措施: Alpha Bio's Graft resorbable membrane (Device)
narrow implant
patients will be installed with NICE Dental implant 3.2 mm diameter
干预措施: NICE dental implant 3.2 mm (Device)
结局指标
主要结局
bone loss
时间窗: 2 years
bone loss level as will be measured from the radio-graphic images
次要结局
- Cumulative implant survival(2 years)