Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft: A Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Horizontal bone width
研究概览
简要总结
This study will be held to overcome the previous limitations related to bone loss after teeth extraction by taking advantages from both Autogenous tooth graft and Simvastatin which will offer a promising synergistic approach for reducing alveolar ridge resorption, enhance bone regeneration and ensuring implant site development for future implant placement. This combination will address the gap in knowledge and offering a novel approach in alveolar ridge preservation. The Autogenous tooth graft will provide a scaffold and growth factor source for bone regeneration while Simvastatin will promotes osteogensis and angiogensis at graft site. So The goal of the present trial aims to evaluate the first-time application of Autogenous tooth graft from extracted tooth combined with Simvastatin with a ratio 1:1(test group) versus Autogenous tooth graft alone (control group) at an extraction socket of non molar single rooted teeth for alveolar ridge preservation and implant site development prior to implant placement.
The participants will be divided into two groups:
Intervention Group will receive Autogenous tooth graft combine with Simvastatin with a ratio 1:1 Control Group will receive Autogenous tooth graft. with follow up period 4 months.
详细描述
Alveolar ridge resorption following tooth extraction is one of the greatest challenges in dentistry, especially for patients seeking dental implants. The alveolar ridge undergoes significant decrease in bone dimensions which will complicate the implant placement and thus necessitate additional grafting procedures to compensate the bone loss. Bone height decreases progressively by 25% during the first year after tooth loss, with a total of 4 mm of height lost during this first year post-extraction.
So various grafting materials such as Autogenous bone grafts, bone substitutes and allografts, are adopted to overcome this challenge and preserve the alveolar ridge. Autogenous grafts are always the gold standard and the benchmark of all graft types because of Its osteoinductive, osteoconductive, and osteogenic. However, secondary surgical sites, pain, high rates of donor site morbidity, and limited supply of graft material are the main disadvantages of autogenous graft.
Among these also, Autogenous tooth graft the promising solution due to its biocompatibility, osteogenic properties and nature compositions that mimics the structure and function of lost bone.
Autogenous tooth graft a type of autogenous grafting technique that utilizes the extracted tooth/teeth of the same individual for the preparation of the graft material. A relatively new and innovative bone graft material with all the advantages of autogenous bone owing to its very similar components to bone and can be very useful in a multitude of clinical situations.
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 (Outcomes Assessor)
盲法说明
Study participants will be blinded and each patient will be given a code by the researcher (N.M). Blinding of the investigator (N.M) isn't applicable. Biostatistician will be blinded. Participants' identity and their corresponding study group will be concealed by assigning an identification number to all laboratory specimens, data files and reports for the transfer data to and from assessors.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with badly broken, non-restorable, or periodontally hopeless non molar single rooted teeth.
- •Age from 20-45 years old(6,13). No sex predilection.
- •Medically free from any medical condition that would interfere with bone healing.
- •Patients with status classification (ASA I & II) with adequate oral hygiene condition.
- •Alveolar sockets free from any preexisting periapical pathology based on intraoral periapical or panoramic radiograph.
排除标准
- •Patients with any medical condition that contraindicated the procedure and general contraindications for Implant Surgery(6,13)
- •Patients who are allergic to Simvastatin drug.(6)
- •Presence of active infection around the tooth or remaining root.
- •Psychological reasons that might affect the procedure or the subsequent follow up visits.
- •Heavy smokers
- •Immunosuppressed or Immunocompromised.(13)
结局指标
主要结局
Horizontal bone width
时间窗: 4 months after grafting
Pre- and Post-ARP CBCT Scans immediately and 4 months after grafting The scans will be compared using predetermined reference points to assess the bone width changes.
次要结局
- vertical bone height(4 months after grafting)
- percentage of newly formed bone(4 months)
研究者
Nourhan Mohamed Abd Elwhab
dentist
Cairo University