NCT00901017已完成不适用
A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change of Vertical Height of Buccal Defects
研究概览
简要总结
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
详细描述
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months.
In total 8 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 Beligum 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
- 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
- •Males and females, 18 years to 80 years of age
- •At least two missing teeth up to full edentulous arches.
- •Desiring implant supported restorations.
- •Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
- •At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
- •Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved;
- •Patients must be committed to the study and must sign informed consent.
- •Patient in good general health as documented by self assessment;
- •Full mouth plaque score of <20%;
排除标准
- •Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
- •Current pregnancy or breast feeding/ lactating at the time of recruitment;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- •Alcoholism or chronically drug abuse causing systemic compromise.
- •Patients who smoke more than 20 cigarettes per day.
- •Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
- •Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly.
- •Mucosal diseases such as erosive lichen planus
- •History of local radiation therapy.
- •Presence of osseous pathologies.
- •Presence of oral lesions (such as ulceration, malignancy)
- •Severe bruxing or clenching habits.
- •Local inflammation, including untreated periodontitis.
- •Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement.
- •Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease.
- •Existing teeth in the residual dentition with untreated endodontic pathologies.
- •Patients with inadequate oral hygiene or unmotivated for adequate home care
结局指标
主要结局
Change of Vertical Height of Buccal Defects
时间窗: Baseline to 26 weeks
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
次要结局
- Implant Success Rate(12 months)
- Implant Survival Rate(12 months)
研究者
研究点 (2)
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