Horizontal Guide Bone Regeneration With or Without Shock Waves: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.
研究概览
简要总结
Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge deficiencies, allowing to restore such defects in order to place bone-integrated dental implants. A few reports exist in the literature about the augmentation of mandibular horizontal ridge defects before implant placement. Published studies show a large variability of reported results regarding horizontal bone augmentation. This can be due to the use of different types of membranes and bone graft materials or a combination thereof. Likewise, an important percentage of graft reabsorption is reported. Although this technique is very much used, an important number of cases must be re-treated or require placing bone graft during implant installation surgery. Techniques are required in order to improve vascularization of the grafts during GBR technique with the aim to improve their clinical success. Recent studies show great interest on the application of shock waves in oral diseases associated to infection and bone loss. The shock waves are acoustic waves that have effects on human biological tissues, stimulating the neo-angiogenesis and the development of a hyper cellularity, showing repairing characteristics on tissues, and starting regenerative processes as a result of metabolism improvement and the increase of local circulation. The extra corporeal shock waves can activate the osteoblasts and their precursors and they have been widely used in orthopaedics for repairing bone fractures. Several clinical studies have shown the effectiveness and safety of shock wave therapy in myocardial revascularization, lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated injuries of soft tissues. No clinical studies exist that assess its effect on guided bone regeneration. The evidence related to the positive effects of the use of shock waves on bone regeneration suggests this treatment as a novelty and a promising therapy that combined with the GBR technique for the treatment of horizontal defects could have an important impact on the potentialization of its clinical effectiveness.
详细描述
General Objective:
Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone graft material in the technique of guided bone regeneration (GBR), combined with the shock wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.
Type of study:
Triple blind randomized clinical trial
Population and sample:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who agree to participate in the study and sign informed consent
- •Partial mandibular edentulism requiring at least two teeth to be replaced with osseointegrated implants
- •Patient with alveolar ridge thickness of ≤4mm, evaluated by CBCT
- •Vertical bone availability of 9mm to anatomical structure such as a chin or dental canal that allows a short implant placement of 8mm at the end of the study.
- •Extractions performed ≥ 6 months
- •Elderly patients between 35 and 65 years old
- •Patients without current disease or with chronic pathologies in medical control that does not affect the healing processes such as: controlled hypertension, controlled hypothyroidism, controlled hypercholesterolemia
- •Evaluated by anamnesis and laboratory tests that rule out processes of immunosuppression, glycemia and coagulation disorders hypercholesterolemia
- •No smoking
排除标准
- •Immunosuppressive drugs
- •Anti-coagulated or with dual anti-platelet aggregation
- •Therapy with bisphosphonates
- •Hormone replacement therapy
- •Patient with a history of radiotherapy of the head and neck
- •Pregnant women or nursing
- •Permanent consumption of NSAIDs and corticosteroids
- •Prolonged antibiotic therapy in the last 6 months
结局指标
主要结局
Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.
时间窗: Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.
Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.
次要结局
未报告次要终点
研究者
Yamil Lesmes
DDS, MSc candidate
Universidad El Bosque, Bogotá