Evaluating the efficacy of application of i-prf on implant stability and marginal bone levels: A randomized clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implant stability measurement,
研究概览
简要总结
A randomized single blinded clinical study will be conducted. A total number of 30 implants will be placed in edentulous spaces in both maxilla and mandible in systemically healthy patients. Patients will be selected based on inclusion criteria. Informed consent will be taken from the patients.Patients were examined clinically, and the residual bone will be evaluated using a CBCT. Blood examinations will be obtained to make sure the individuals were ideal candidates. Each 15 implants**(NORIS,Int.HexTi.Tufted implant)** will be randomly allocated to Test (with I-PRF) and Control (without I-PRF) groups.Implant stability will be measured in 2 groups immediately after implant placement (baseline),10 days,1 month, 3 months and 6 months and marginal bone levels will be measured at 3 and 6 months.All the parameters will be recorded by other operator to avoid Bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •i)Systemically healthy patients(ASA I,II).
- •ii)Patients with Stable occlusion.
- •iii)Adequate bone height and width at the surgical site.
- •iv)Adequate mesiodistal and interocclusal spaces in the edentulous area.
排除标准
- •â—¦Presence of active periodontal disease.
- •â—¦Pregnancy or Lactation women.
- •i)Patients with any systemic disease and medications that will interfere with treatment outcome.
- •ii)History of radiotherapy or chemotherapy.
- •iii)Primary stability less than 25 Ncm during fixture placement.
结局指标
主要结局
Implant stability measurement,
时间窗: Baseline,10 days,1 month, 3 months and 6 months
Radiographic evaluation
时间窗: Baseline,10 days,1 month, 3 months and 6 months
次要结局
- Radiographic evaluation(3 months and 6 months)
研究者
Jyothi Prasanna Paritala
GSL Dental College and Hospital