Clinical, Radiographic, and Histomorphometric Outcomes Following Ridge Preservation Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-Dried Bone Allograft (FDBA) Layered Technique: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Measurements of the Radiographic Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique
研究概览
简要总结
This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement.
Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone.
Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.
详细描述
This study is a prospective, three-arm randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets using either L-PRF/FDBA layered technique or L-PRF/FDBA or L-PRF alone in a total of 30 patients (10 in each arm).
Qualifying participants and defects will be randomized following a computerized permutation block to receive either technique on day of surgery. Tooth extraction will be performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft.
The mineralized cortico-cancellous bone allograft that will be used in this study will be obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.
Bone core biopsies will be harvested at time of implant placement 3 months following socket grafting. Bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between three treatment groups.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking and able to read and understand English informed consent document
- •At least 18 years old.
- •Must be a patient at the UAB School of Dentistry
- •Patient is willing and able to comply with all steps of the study
- •Hopeless single-rooted tooth planned to be replaced with a dental implant and with healthy adjacent teeth not planned for extraction.
排除标准
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Pregnant women
- •Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
结局指标
主要结局
Measurements of the Radiographic Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique
时间窗: From baseline to 3 months
Compare quantitative radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan. The bone width at the extraction site will be measured on the CBCT taken directly after the extraction. The same measurement will be taken at the 3 month follow up CBCT. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement.
Assessments of the Histology of the Bone Harvested at the 3 Month Visit.
时间窗: 3 months
Measure quantitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone at the healed socket site. The quality of the bone created will analyzed using a descriptive analysis.
Measurements of Clinical Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique
时间窗: From baseline to 3 months
Compare quantitative clinical alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups. Clinically we will measure the bone width of the ridge at time of extraction and after three months during the implant placement procedure. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement.
次要结局
未报告次要终点
研究者
Nicolaas C. Geurs, DDS, MS
Principal Investigator
University of Alabama at Birmingham