Assessment of Bone Quality After Defective Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone : A Histomorphometric Randomized Clinical Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Histomorphometric analysis
研究概览
简要总结
The aim of study to evaluate the quality and quantity of the formed bone after socket preservation using sticky bone versus alendronate gel
详细描述
this study is alternative hypothesis research based on that one technique will be more efficient and effective than the other. In our case, the bone produced after introducing the sodium alendronate drug in defective sockets will be beneficial and will have better density and histomorphological features than treating the socket with sticky bone technique .
Several socket preservation techniques with different regenerative biomaterials and procedures as bone grafts, membranes, biological modifiers and platelet concentrates were introduced in the literature to overcome these problems.
Some researchers tried to introduce alternative techniques to preserve the socket depending on the enhancement of the native physiological mechanism of bone formation without the need for grafting through utilization of chemical agents that interfere with bone resorption, among these agents are the Bisphosphonates. Bisphosphonates are originally used in diseases with increased bone resorption as osteoporosis, paget's and fibrous dysplasia, hypercalcemia of malignancies.
The Effect of local delivery of alendronate on bone resorption following mucoperiosteal flap in mandible of rats was examined in Oxford Dental College Hospital, Bomannahalli on patients between 30 to 65 years old .and they found that alendronate reduces the resorptive activity of alveolar ridge significantly. It was found that local alendronate reduces active bone resorption without interfering with bone mineralization and quality. On remodeling surfaces local bisphosphonates binds to apatite crystals inhibiting their growth, aggregation and dissolution. As a result it decreases the turnover rate and increasing the mass and strength of bone.
Many authors as Jakobsen in 2009, supports the results from a study That found that the local Bisphosphonate (alendronate) treatment gives good bone quality and quantity.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •defective class III sockets
- •Patients with non-restorable teeth extracted sites
- •Patients who have given their consent for this trial.
- •Both genders males and females will be included.
排除标准
- •Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
- •Subjected to irradiation in the head and neck area less than 1 year before implantation.
- •Patients having history of allergy to any drugs.
- •Patients who have a history of any concomitant major known medical problem and/or ongoing pharmacologic treatments
- •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.
- •Active infection or severe inflammation in the area intended for 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.
研究组 & 干预措施
sodium alendronate group
prepared sodium alendronate gel will be placed in defective extraction sockets.
干预措施: socket preservation using sodium alendronate gel (Procedure)
stickybone group
20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket.
干预措施: socket preservation using sticky bone (Procedure)
结局指标
主要结局
Histomorphometric analysis
时间窗: 3 month from the socket preservation procedure
bone sample will be taken and bone quality will be assesed
次要结局
- Bone density(3 month)
- alveolar crest bone height(3 month)
研究者
Aya Reda Hamed Elgohary
principal investigator
Cairo University