NCT00900718已完成不适用
Comparison of Straumann Bone Ceramic (SBC) and Bio-Oss in Combination With Guided Tissue Regeneration (GTR) for Volume Preservation of Alveolar Ridge After Tooth Extraction: a Randomised, Single Blind, Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The changes of bone level between baseline and 32 week post-extraction
研究概览
简要总结
The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of dental implants placed in the augmented socket area and to assess radiographically and clinically changes of peri-implant soft and hard tissues.
详细描述
This is prospective, randomized, single-blind, controlled, single center study. The total study duration for each patient should be 12 +/- 1 month.
In total 13 visits per patient are scheduled in this study.
The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.
One center in the Inited Kingdom will participate.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have voluntarily signed the informed consent
- •Males and females, 18 years to 75 years of age
- •Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
- •Patients must be committed to the study and must sign informed consent
- •Patient in good general health as documented by self assessment
排除标准
- •Systemic exclusion criteria
- •Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
- •Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
- •Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
- •Patient who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily asprin of more than 81 mg.
- •Patient who knowingly has HIV or Hepatitis
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Patient who has undergone administration of any investigational drug within 30 days of study initiation.
- •Alcoholism or chronically drug abuse causing systemic compromisation
- •Patient who is a heavy smoker (>10/cigarettes per day).
- •Patient is suffering from a known psychological disorder
- •Patient has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed
- •Local exclusion criteria
- •Uncontrolled or untreated periodontal disease
- •Bone defects that excludes implant restoration
- •Patient who has a full mouth plaque level >30 % at the enrolment visit
- •Mucosal diseases such as erosive lichen planus
- •History of local radiation therapy
- •Presence of oral lesions (such as ulceration, malignancy)
- •Severe bruxing or clenching habits
- •Persistent intraoral infection
- •Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
- •Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)
结局指标
主要结局
The changes of bone level between baseline and 32 week post-extraction
时间窗: baseline and 32 week post-extraction
次要结局
- implant success and survival rate(1 year post implant loading)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Straumann Bone Ceramic Versus BioOss in Sinus ElevationJaw, Edentulous, PartiallyAlveolar Bone LossNCT00900822Institut Straumann AG11
已完成
不适用
Maxillary Sinus Elevation With Bio-Oss or Straumann BoneCeramicTeeth LossBone LossNCT00901121Institut Straumann AG48
招募中
不适用
Efficacy of Bioceramic Materials for Bone Defects RepairBone LesionCartilage DegenerationOsteo Arthritis KneeBone FractureBone InjuryBone LossNCT06249906Nanjing First Hospital, Nanjing Medical University10
尚未招募
3 期
Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent MolarsPulpotomyDeep CariesNCT06219824Cairo University40
进行中（未招募）
2 期
The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.Revascularization of Immature Young Permenant TeethNCT06630156Al-Azhar University28