Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting " Randomization Clinical Trial"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change bone gain
研究概览
简要总结
This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone.
详细描述
The main prerequisite of achieving proper implant placement with ideal functional and proper restoration particularly in the posterior maxilla may compromise with violation to Schneiderian membrane especially in pneumatized maxillary Antrum when RBH < 4 mm, Conventional lateral sinus floor elevation (CLSFE) is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics in severe atrophic maxilla.
The objective of this study was to evaluate sinus elevation with simultaneous implant placement using open technique and bone ring versus sticky bone clinically and radiographically in terms of secondary stability and bone gain around the implant
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 (Care Provider)
盲法说明
This trial is considered a randomized double blind clinical trial due to the following:
- The participant will be blinded to the technique that will be used during the surgical operation.
- The outcome assessor will be blinded
- The operator (DR.O.S.) will not be blinded for both techniques during the surgical operation, as the two techniques are different. (Dr. M.O.).
The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes.
入排标准
- 年龄范围
- 26 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with edentulous vertically deficient posterior maxillary ridge a 4-5 mm. height of alveolar bone.
- •Both males as well as females without any active periodontal disease.
- •All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
- •All selected patients are non-smokers and non-alcoholics.
- •Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
- •The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- •Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
排除标准
- •On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- •General contraindications to implant surgery.
- •Subjected to irradiation in the head and neck area less than 1 year before implantation.
- •Untreated periodontitis.
- •Poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnant or nursing.
- •Substance abuse.
- •Psychiatric problems or unrealistic expectations.
- •Severe bruxism or clenching.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- •Active infection or severe inflammation in the area intended for implant placement.
- •Need of bone augmentation procedures at implant placement.
- •Unable to open mouth sufficiently to accommodate the surgical tooling.
- •Patients participating in other studies, if the present protocol could not be properly followed.
- •Referred only for implant placement or unable to attend a 5-year follow-up.
结局指标
主要结局
Change bone gain
时间窗: Immediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measured
bone gain (increase bone volume) Measuring the crestal bone height by CT.
次要结局
未报告次要终点
研究者
Omar Saleh Ahmed Bassed
Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting
Cairo University