Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts in Implant Bone Reconstructive Procedures; A Histological and Radiographical Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bone density measurement
研究概览
简要总结
Thirty healthy patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included in this study with non-restorable posterior teeth.Patients will be selected according to the following criteria: 1) having a non-restorable posterior tooth. 2) being healthy, with no systemic diseases that might contraindicate receiving a dental implant. 3) having good oral hygiene. 4) aged between 18 to 45 years old. 5) having sufficient alveolar bone volume and height at the future implant site.Patients were classified into three groups:
- Group I: ten extraction sockets left for normal healing (blood clot).
- Group II: ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).
- Group III: ten extraction sockets filled with Allograft bone grafting material.Evaluation and Follow-up
All patients will be evaluated clinically and radiographically during a follow up period of 4 months, where the following criteria will be evaluated:
A- Clinical evaluation:
- Patients will be evaluated at 1 week, 4 weeks and 8 weeks.
- Clinical evaluations of soft tissue healing, and keratinized tissue replacement will be assessed on the basis of the healing index proposed by Landry et al12.
- The scores will assess healing on the basis of redness, presence of granulation tissue, bleeding, suppuration, and epithelization.
- The surgical region will be examined clinically, if there is pain, redness, tissue resorption and bone graft stability.
B- Radiographic evaluation:
- Cone Beam Computed Tomography scan will be taken immediately after implant placement, and after 12 months.
- All patient scans will be taken by a Planmeca ProMax 3D unit (Planmeca OY, Helsinki, Finland) using fixed imaging parameter at every scan. All DICOM data will then be analyzed using On Demand 3D software (Version 1, Cyber Med, Seoul, South Korea).
- The vertical and horizontal measurements will be measured.
- The apico-coronal dimension will be calculated, the bottom of the socket will be considered the most apical point, whereas the alveolar bone margin will be considered the most coronal point of the socket bone wall.
C- Histological evaluation:
- Bone samples will be collected with trephine bur before implant placement, then fixed in 10% neutral buffered formalin for 24 hours, then transferred to 14% neutral buffered Ethylenediaminetetraacetic acid (EDTA) for decalcification 13. After confirming adequate decalcification, the specimens will be processed and embedded in paraffin blocks in the Pathology department, faculty of Medicine, Mansoura university for histological assessment, then stained with haematoxylin and eosin (H&E) as a routine stain to evaluate the quality of newly formed bone.
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
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having a non-restorable posterior tooth.
- •being healthy, with no systemic diseases that might contraindicate receiving a dental implant.
- •having good oral hygiene.
- •aged between 18 to 45 years old.
- •having sufficient alveolar bone volume and height at the future implant site
排除标准
- •having received radiation therapy at the head and neck area or chemotherapy in the past 12 months.
- •having uncontrolled diabetes.
- •having poor oral hygiene or motivation.
- •having bruxism or other parafunctional habit.
- •having infection or inflammation at the proposed implant site.
结局指标
主要结局
Bone density measurement
时间窗: 4 months
CBCT will be used to assess bone density categories and HU
次要结局
未报告次要终点
研究者
Heba Elsheikh
assistant professor of oral and maxillofacial surgery
Mansoura University
