A randomized controlled clinical trial to evaluate the efficacy of A-PRF on crestal bone level around Immediate Dental Implant
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- peri-implant probing depth and IOPAR radiograph
研究概览
简要总结
· Background: Dental implant is a newer treatment modality to replace the missing tooth. The conventional protocol for dental implant placement suggested 3 to 6 month waiting period for healing following tooth extraction. In immediate dental implant placement, implant is directly placed at time of extraction which eliminate the waiting period for socket healing. Immediate dental implants have revolutionized implant dentistry by drastically shortening the treatment time. After tooth extraction, the crestal bone loss occurs which continue even after placing the immediate implant. To prevent or reduce crestal bone loss various bone grafts and membrane are used. In the present study, A- PRF will be mixed with bone graft as an autologous biomaterial to promote bone healing.
· Novelty: A-PRF mixed with bone graft will be placed between immediate implant and socket wall which facilitate bone formation. More number of leucocytes and platelets are present in A-PRF which is prepared by decreasing RPM (rotation per minutes) and increasing the centrifugation time. A-PRF releases growth factors in a slow and continuous manner for longer duration.
· Objectives: To find out the effect of A-PRF on crestal bone level around immediate implant clinically and radiographically.
· **Methods:**The present study is a randomized controlled clinical trial. Patients will be selected as per inclusion criteria and randomly divided into two groups on the basis of placement of A-PRF. In Group I, immediate implant placement with bone graft around the implant whereas in Group II, immediate implant placement with A-PRF and bone graft around the implant will be done. The clinical parameters which include PI and GI will be assessed before implant placement and at after 3 months of implant loading. PPD will be assessed at the time of implant loading and at after 3 months of implant loading and radiological parameter include crestal bone level will be assessed by using IOPAR / CBCT will be recorded at baseline, 3 months, at time of implant loading and 3 months after implant loading.
Expected outcomes: This study expects to find out the additional effect of A- PRF with bone graft around the immediate implant results in less crestal bone loss as compared to sites where A-PRF is not placed along with immediate implants.·
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Teeth that require extraction due to fracture of root, residual roots, internal and external resorption, endodontic failures, non-restorable carious lesions, over-retained deciduous teeth, Sufficient alveolar bone at the site, systematically healthy patient, No acute infection.
排除标准
- •Medically compromised patients, Poor bone quality or volume, Para functional habits, Habit of smoking, alcohol intake or drug abuse, Pregnant woman and lactating mother, non-compliance patient.
结局指标
主要结局
peri-implant probing depth and IOPAR radiograph
时间窗: Peri-implant probing depth will be assessed at the time of implant loading and after 3 months of implant loading. | IOPAR will be taken to assess the crestal bone level (from platform of implant till bone level) at baseline, at 3 months, at time of implant loading (After 4-6 months of implant placement), and at 3 months after implant loading.
次要结局
- plaque index (PI) and gingival index (GI)(PI and GI will be assessed before implant placement and after 3 months of implant loading.)
研究者
Dr Mohit Bansal
Uttar Pradesh University of Medical Sciences