Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Crestal bone level
研究概览
简要总结
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
详细描述
Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
A statistician not involved in the study performed the randomization in blocks of four and the assignments have been sealed in coded and opaque envelopes that will be opened at the time of the enrollment of each patient in the study. The surgeon will be blinded about the assignment until the time of the surgery. The outcome assessor will be blinded about the protocol
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Edentulous maxilla
- •Willing to receive a full arch fixed restoration in the maxilla.
- •Latest extraction at least 8 weeks before implant insertion
- •Sinus floor height included between 4 to 6 mm
- •Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
- •In the anterior maxilla (from first premolar to first premolar) bone width sufficient to allow the insertion of 10 mm long implants of standard diameter. Minor horizontal augmentations with guided bone regeneration procedures was allowed in the anterior maxilla.
- •the opposing arch have to present one of the following conditions:
- •natural dentition (at least 10 elements from 3.5 to 4.5)
- •Fixed dental prosthesis of at least 10 elements (from 3.5 to 4.5) supported by teeth or implants
- •Implant supported or teeth supported overdentures
- •Adequate partial removable prostheses.
排除标准
- •Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
- •Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
- •Current pregnancy or breastfeeding women
- •Smokers > 10 cigarettes per day
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Immunocompromised patients including patients infected with HIV
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
- •Patients with an ongoing or previous treatment with bisphosphonates (for at least 2 months for oral therapy or 6 months for IV injection)
- •Local exclusion criteria
- •Local inflammation, including untreated periodontitis
- •Pre-cancerous oral lesions
- •History of local irradiation therapy
- •Severe bruxism or clenching habits
- •Patients with inadequate oral hygiene or unmotivated for adequate oral home care
- •Previous Guided bone regeneration or Guided tissue regeneration treatment at the implant site
- •Total removable prosthesis in the lower arch
研究组 & 干预措施
Short Group
In each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed
干预措施: Placement of extra short implants (Procedure)
Standard group
sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus.
干预措施: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation (Procedure)
Standard group
sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus.
干预措施: placement of standard implant (Procedure)
结局指标
主要结局
Crestal bone level
时间窗: 24 months
Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.
survival rate of 4 mm implants used as distal support
时间窗: 24 months
To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.
次要结局
- Technical complications(24 months)