Trans-crestal Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail With Parallel Group Design: L-PRF Compared With DBBM
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Volumetric bone regeneration en volumetric change
研究概览
简要总结
This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with "the golden standard" DBBM, after trans-crestal sinus floor elevation.
详细描述
This is a randomized controlled clinical trial with parallel group design. A total of 40 patients, needing transcrestal sinus lift (T), will be enrolled.
Under local anesthesia, the required T and implant placement will be performed and ISQ values will be recorded. Afterwards a CBCT will be taken for control. Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factors RBH. Allocation will be concealed to the surgeons at completion of the common part of treatment, by opening an opaque envelope. At the same time an oral implant(s) will be inserted in the augmented area.
After 6 months a CBCT will be taken for control of the bone healing and the measurements of the newly formed bone. The abutment will be placed on top of the osseo-integrated implant(s) under local anesthesia. ISQ values will be recorded. Follow-up will be till 1 year.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Need for T and oral implant placement.
- •RBH >3mm
排除标准
- •Unlikely to be able to comply with the study procedures, as judged by the investigator
- •Untreated periodontal disease
- •Unfavorable plaque control
- •Known or suspected current malignancy
- •History of chemotherapy within 5y prior to study
- •History of radiation on the head and neck region
- •History of other metabolic bone diseases
- •Need for systemic corticosteroids
- •Current or previous use of intravenous/oral bisphosphonates
- •Present alcohol and/or drug abuse
- •Involvement in the planning and conduct of the study
- •Psychiatric disorders which do not allow a normal treatment outcome
结局指标
主要结局
Volumetric bone regeneration en volumetric change
时间窗: 6 and 12 months
Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images. Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software.
Linear bone regeneration en lineair change
时间窗: 6 and 12 months
Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images. Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurement will be performed.
次要结局
- Implant stability based on resonance frequency(6 months)
研究者
Drs. Simone Cortellini
Clinical and Research Associate
Universitaire Ziekenhuizen KU Leuven