Autologous Leukocyte-platelet Rich Fibrin (L-PRF) Versus a Xenogeneic Bone Substitute Combined With a Collagen Matrix for Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography)
研究概览
简要总结
After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Different bone filling materials have been used with good clinical results. The second-generation platelet concentrates (L-PRF) have recently been shown to induce bone regeneration when filling the socket after extraction, with significant biological and economic advantages. The hypothesis of this study is to test whether or not the use of L-PRF in alveolar ridge preservation results in a non-inferior horizontal radiographic change compared with the combination of a xenogeneic bone substitute with a collagen matrix.
详细描述
This study is a non inferiority clinical controlled trial of parallel groups. Study Intervention and Indication
After single premolar extractions in the maxilla or mandible area, patients will be randomly allocated to either one of the two treatment modalities:
- Alveolar ridge preservation using L-PRF (test)
- Alveolar ridge preservation using xenogeneic bone covered with a collagen matrix (control)
Study objectives Primary Objective The present study aims to test whether or not the use of L-PRF in alveolar ridge preservation results in non-inferior horizontal ridge width changes measured at - 1 mm below the most coronal aspect of the alveolar crest compared to the combination of a xenogeneic bone substitute material with a collagen matrix, 4 months after tooth extraction.
Clinical procedures
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants: During the socket preservation surgery, the type of intervention will be disclosure to the surgeon. The patient will not have access to this information. Also, during the controls and following interventions (implant placement and rehabilitation), the intervention group will be masked (test or control).
Investigator: The investigators will be always masked to the intervention group. (Only the surgeon will be able to know the treatment sequence, during the surgery) Outcomes assessor: The outcome reviewers will be blinded to the intervention. The measures of initial cbct, 4 months cbct control, and the following measurements will be always blind with respect to the intervention group.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontally healthy individuals with at least 18 years of age
- •Good oral hygiene (BOP & Pl ≤ 20%)
- •Patients with a single failing premolar in the maxilla and mandible.
- •With or without buccal plate after tooth extraction (similar cases in both groups)
- •Surrounded by a mesial and distal natural tooth
- •Capability to comply with the study procedures
- •Informed Consent as documented by signature
排除标准
- •Pregnant or lactating women
- •Known or suspected non-compliance, drug or alcohol abuse
- •Smokers (>10 cigarettes/day)
- •Systemic or local conditions presenting a contraindication to implant treatment
- •Currently taking drugs that influence bone metabolism
- •Use of bisphosphonates in the last 4 years
- •History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
结局指标
主要结局
Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography)
时间窗: first cbct immediately after socket preservation surgery, second cbct 4 months after surgery, 12 months after the final restoration of the implant.
Cone-beam computed tomographic (CBCT) imaging will be used to assess the primary outcome (horizontal radiographic changes at -1 mm below the alveolar crest) in both groups between baseline 1 (immediately post socket preservation), visit 4 (4 months after socket preservation), and 12 months after implant rehabilitation. Linear measurements will be performed. The most apical point of the extraction socket will be defined, and two reference lines will be subsequently drawn. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. A horizontal reference line will be drawn perpendicular to the vertical line crossing the apical reference point. Based on these reference lines, the horizontal ridge width will then be measured at -1 mm below the alveolar crest (HW-1). The same procedure will be applied for assessing the horizontal ridge width changes will then be measured at -3 mm (HW-3) and 5- mm (HW-5) below the alveolar crest.
次要结局
- White esthetic score (WES)(10 days, 6, and 12 months after final restoration)
- Peri-implant Keratinized Mucosa(10 days, 6, and 12 months after final restoration)
- Phenotype(10 days, 6 and 12 months after final restoration)
- Radiographic evaluation(10 days, 6, and 12 months after final restoration)
- Probing depth(10 days, 6, and 12 months after final restoration)
- Oral Health Impact Profile (OHIP-14)(at baseline, 6 and 12 months after final restoration)
- Mucosal height(4 months after implant insertion, at the final restoration delivery)
- Bleeding on probing(10 days, 6, and 12 months after final restoration)
- Profilometric Changes(at baseline (socket preservation), 4 months (implant insertion), 10 days and 12 months after final restoration delivery)
- Pink esthetic score (PES)(10 days, 6, and 12 months after final restoration)
- Visual analog scale for pain assessment (VAS)(Pain perceived, 24 hrs after socket preservation and implant insertion (4 months).)
研究者
Antonio Sanz
Prof.
Universidad de los Andes, Chile