Prospective Comparative Evaluation of Alveolar Ridge Preservation: Mixing Allograft With Xenograft VS. Allograft Alone in Atraumatic Extraction Sockets
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Three-dimensional hard and soft tissue change using CBCT/ intraoral scan
研究概览
简要总结
This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the jawbone surrounding the removed tooth can shrink, affecting future implant placement. By placing a bone graft material in the extraction socket, we aim to maintain adequate jawbone space for future implants. This study compares how well the mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) [test], and vallos® only [control] grafting materials work.
Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study. Participants will be randomly assigned to either the mixture of vallos®f and Bio-Oss (test) group or the vallos® only (control) group.
Throughout the approximately 2-year study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material placement, and dental implant placement. After the crown is placed on the implant, participants will attend follow-up visits.
Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •At least 18 years old
- •In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
- •Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
- •At least one retained natural tooth adjacent to the study site
排除标准
- •Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
- •Previous interventions performed involving soft and/or bone grafting in the study site
- •Active treated caries
- •Uncontrolled periodontal disease present
- •Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
- •History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
- •Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
- •Self-reported use of smokeless tobacco or e-cigarette
- •Self-reported history of current alcohol or drug abuse
- •Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c > 8.0 within last six-month
- •Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
研究组 & 干预措施
Alveolar ridge preservation with Allograft/Xenograft group
The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with the mixture of demineralized cortical allograft vallos®f and xenograft bone substitute called Bio-Oss®.
干预措施: Allograft/Xenograft (Device)
Alveolar ridge preservation with Allograft group
The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with mineralized cortico-cancellous bone substitute called vallos®.
干预措施: Allograft (Device)
结局指标
主要结局
Three-dimensional hard and soft tissue change using CBCT/ intraoral scan
时间窗: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 1-year post implant-supported crown delivery [Visit 11]).
Evaluate the efficacies of Alveolar Ridge Preservation in three-dimensional ridge hard and soft tissue change in volumetric and linear measurement using CBCT and intraoral scan over time
次要结局
- Comparison of implant positions of digital planning based on the CBCT scan before and after Alveolar Ridge Preservation will be compared.(4-5 months (Before Alveolar Ridge Preservation/ Enrollment [Visit 2] to 4-month follow-up [Visit 7]))
- Histomorphometric analysis of the bone harvested from the grafted site(5 months (At the time of implant placement [Visit 8]))