Effect of Simvastatin-Platelet Rich Fibrin (PRF) Combination Vs PRF and Allograft Combination Vs PRF Alone as Peri-Implant Gap Filling Graft Materials around Immediate Implants on Vertical Bone Implant Contact and Implant Stability: A Pilot Randomized Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA
研究概览
简要总结
Dental implants are placed in oral cavity to replacemissing teeth. If they are placed in fresh extraction sockets, they are calledas “Immediate implantsâ€. To promote the bone formation around implants and tohasten healing, we need to put some graft material in the gap present betweenthe socket walls and the implant. These graft materials can be artificial bonederived from different sources or platelet rich fibrin derived from patient’sown blood. Recently Simvastatin (medicine used for patients with heart relatedproblems) has been used in animals and humans to promote bone formation. Inthis study, it will be prepared in form of gel in department of Pharmacologyand its effect will be assessed on bone formation around implants and if thereis any improvement in stability of implants in one year time period. For that,36 patients with poor prognosis of upper front teeth will be enrolled. Toothwill be extracted followed by implant placement and grafting with one of thegraft materials. Artificial crown will be fabricated over implant after 3months and patients will be kept on follow up till one year after implantplacement. Bone formation will be measured on radiographs two times (just afterimplant placement and at one year) and stability of implants will be measuredthree times ((just after implant placement, at 3 months and at one year). If wefind good results, Simvastatin can be used in multiple clinical scenarios topromote bone formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with good systemic general and periodontal health, irrespective of sex and having age between 18-45 years 2.Patients in need of anterior single tooth extraction (maxillary incisors, canines, or premolars) because of any indication like failed endodontics, poor prognosis of repeat RCT, trauma, mobility, root fracture etc 3.Perimplant gap ≥ 2mm 4.Willing for participation in study, giving written informed consent and follow up.
排除标准
- •1.Patients with parafunctional habits, history of smoking, diabetes, any other systemic health problem, immuno compromised state, or pregnant females.
- •2.Symptomatic periapical lesions, acute abscesses, or sinus tracts in relation to tooth in question or adjacent teeth 3.Secondary exclusion criterion kept will be peri implant gap of more than 5mm 4.Primary stability of less than 35 N/cm.
结局指标
主要结局
Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA
时间窗: Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA immediately after surgery, 6 months after surgery and one year. CBCT immediately and one year after surgery.
次要结局
- Secondary outcome variable (SOV): Implant stability (Implant stability quotient values measured on Radio frequency analyser)(SOV will be measured at baseline, at 3 months and at one year.)