Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
研究概览
简要总结
This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).
详细描述
This is a prospective, randomized, and examiner-only-masked study. It is designed to clinically compare the use of bone particulate allograft hydrated with rhPDGF vs bone particulate allograft hydrated with saline, for patients who were planned to receive dental implants but presented with deficient bone ridges. This investigation of two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).
In two arms, bone core biopsies will be harvested at time of implant placement 4 months following ridge augmentation grafting. These 2x8mm bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between in both study arms.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
Cone beam computed tomography (CBCT) initial scans are conducted immediately following prior to ridge augmentation and second scans obtained prior to implant placement both arms. These types of Cone Beam CT scans as well as conventional dental x-rays are valuable treatment planning tools that are commonly used in modern-day implant dentistry. The scans and the x-ray images are also used to monitor the health of tissues surrounding implants and to make sure that the implant remains securely implanted into the jawbone over time.
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)
盲法说明
The calibrated, trained, masked-examiner (who is unaware of which Group the patient is randomized), will be masked and available during the entire duration of the study.
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
- •At least 18 years old
- •Must be a patient of the UAB Dental School
- •Able to read and understand informed consent document
- •Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
- •Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
排除标准
- •Non-English speaking
- •Less than 18 years old
- •Smokers/tobacco users (>10 cigarettes/day)
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
- •Vertical loss of bone at edentulous ridge.
研究组 & 干预措施
Allograft particles hydrated with rhPDGF
Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
干预措施: Allograft particles hydrated with rhPDGF (Biological)
Allograft particles hydrated in a conventional way with saline.
Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
干预措施: Allograft particles hydrated in a conventional way with saline. (Biological)
结局指标
主要结局
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
时间窗: From baseline to 4 months
To quantify the distribution of the different tissues (new bone, soft tissue, residual graft and artifact) after 4 months of healing. Hence, the primary outcome will be the new bone formation, defined as the percentage of new bone area in the histomorphometric sections.
次要结局
- Quantitative two- and three-dimensional radiographic comparison of dimensional changes 4 months using cone beam computed tomography (CBCT) and a virtual implant planning software, coDiagnostiX™(From baseline to 4 months)
研究者
Hussein Basma
Principal Investigator
University of Alabama at Birmingham