The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Buccal soft tissue contour around dental implant
研究概览
简要总结
The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.
详细描述
Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
- •Healthy persons at least 18 years old.
- •Understands and has signed the informed consent.
排除标准
- •Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
- •Previous head and neck radiation.
- •Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.
- •Smokers (or other tobacco habits that might interfere with soft tissue healing).
- •Patients who need prophylactic antibiotics prior to dental procedures.
- •Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
- •Chemotherapy in the previous 12 months.
- •Psychological problems that would interfere with treatment.
- •Pregnant subjects will be excluded due to risk of miscarriage
- •Patients unable or unwilling to sign the informed consent.
结局指标
主要结局
Buccal soft tissue contour around dental implant
时间窗: 3 months
Contour will be categorized as concave,flat or convex(subjective categories).
次要结局
- Buccal soft tissue thickness around dental implants(3 months)
研究者
Henry Greenwell
Professor
University of Louisville