NCT00782236终止4 期
Comparison of an Alloplast (Straumann Bone Ceramic) to an Allograft of Freeze Dried Bone (FDBA) for Preservation of the Alveolar Ridge Following Tooth Extraction: a Prospective, Randomized, Controlled Clinical Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
研究概览
简要总结
The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).
详细描述
Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.
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
- None
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
- 否
入选标准
- •Subjects must have voluntarily signed the informed consent form
- •Subjects must be between the ages of 18 and 80
- •Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
- •Subjects must be committed to the study and the required follow-up visits
- •Subjects must be in good general health as assessed by the Investigator
排除标准
- •Presence of conditions requiring chronic routine prophylactic use of antibiotics
- •Pregnancy
- •Medical conditions requiring prolonged use of steroids
- •History of leukocyte dysfunction and deficiencies
- •History of bleeding disorders
- •History of neoplastic disease requiring the use of chemotherapy
- •History of radiation therapy to the head and neck
- •Subjects with a history of renal failure
- •Subjects with severe or uncontrolled metabolic bone disorders
- •Uncontrolled endocrine disorders
- •Subjects who knowingly have HIV or hepatitis
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study
- •Alcoholism or drug abuse
- •Subjects who are heavy smokers (>10 cigarettes per day or cigar equivalents) or chew tobacco
- •Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- •Local inflammation including untreated periodontitis
- •Mucosal diseases such as erosive lichen planus
- •History of local radiation therapy
- •Presence of oral lesions (such as ulcerations or malignancy)
- •Bone defects that exclude implant restoration
- •Subjects who have a full mouth plaque level >30% at the baseline visit
- •Severe bruxing or clenching habits
- •Persistent intra-oral infection
- •Subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible)
- •Subjects with inadequate oral hygiene or unmotivated for adequate home care
- •At the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)
结局指标
主要结局
Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
时间窗: Six weeks following dental implant placement
次要结局
- Mesial and distal implant bone level changes(6 weeks, 12 weeks, 6 months, and 12 months following implant placement)
- Periodontal measurements(6 months following tooth extraction and 6 and 12 months following implant placement)
- Histological evaluation(6 months following tooth extraction)
- Alveolar ridge width and height changes(6 months following tooth extraction)
- Grafting procedure success rate(14 days, 1 month, 3 months, and 6 months following tooth extraction)
- Implant success and survival rate(6 weeks, 12 weeks, 6 months, and 12 months following implant placement)
- Patient satisfaction(6 and 12 months following implant placement)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Initial Stability of Posterior Maxillary Implants With Bicortical FixationTooth LossNCT01237184University of Minnesota45
招募中
不适用
Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement TechniquesImplant StabilityNCT06599112Cairo University36
尚未招募
不适用
to verify and compare Crestal bone levels and implant stability for dental implants when they are placed and immediately loaded in grafted and non-grafted bone- split mouth studyCTRI/2021/02/031135SAKSHI RAWA
尚未招募
3 期
Bone performance of ultraviolet light activated dental implants used for overdentures in patient with moderately controlled diabetesCTRI/2024/07/069739Dr Harshal Jain
已完成
不适用
A Study of Dental Implants Coated With Bone Morphogenetic ProteinAlveolar Ridge AbnormalityNCT00422279Nobel Biocare4