Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Implant Stability as Measured with ISQ values of implant
研究概览
简要总结
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site.
Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA
Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
详细描述
This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.
Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.
Protocol of the experiment is as follows:
- Surgical intervention for implant placement (for all the groups).
- 2-week follow-up after implant placement.
- 6-week follow-up after implant placement.
- 4-6 month follow-up after implant placement.
- Restoration of the implant by the restorative dentist.
- Data analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Investigator completed randomization program and delivered grafting material to patient/dentist at time of grafting. Patients and providers still blinded as to which group they were assigned.
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
- •Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019)
- •Well-controlled systemic disease.
- •Able to understand and sign a written informed consent form and willing to fulfill all study requirements.
排除标准
- •Uncontrolled systemic disease.
- •Currently smoking >10 cigarettes per day.
- •History of head and/or neck radiotherapy in the past five years.
- •Current use of bisphosphonates or history of IV bisphosphonate therapy.
- •Pregnant, expecting to become pregnant, or lactating women.
- •Presence of active periodontal disease.
结局指标
主要结局
Implant Stability as Measured with ISQ values of implant
时间窗: 6 months
Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments
Implant Failure Rate
时间窗: 6 months
Necessity of implant of implant removal from oral cavity
Probing pocket depth
时间窗: 6 months
measuring the depth of the periodontal pocket alongside the dental implant
Interproximal crestal bone level
时间窗: 6 months
radiographically assess bone level changes adjacent to dental implant
次要结局
未报告次要终点