Evaluation of Immediately Placed Dental Implants With Local Application of Injectable-Platelet Rich Fibrin in Periodontally Compromised Sites. A Randomized Controlled Split Mouth Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Crestal bone level
研究概览
简要总结
The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to explore the efficacy of injectable PRF around dental implants. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.
All the patients were treated with immediate implants. The injectable -PRF was coated on implants as well as injected in the socket in both the maxillary and mandibular anterior region. The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative patients willing to participate in the study
- •At least two maxillary or mandibular anterior teeth indicated for extraction due to chronic periodontitis (chronic or aggressive)
- •Patients above 18 years of age
- •Patients with esthetic concerns
- •Patients with good oral hygiene maintenance
- •Adequate bone height apical to alveolus of the failing teeth (more than or equal to 5mm) to accommodate an implant
排除标准
- •Persistent & unresolved infection at implant site
- •Teeth with close proximity to anatomical structure and adjacent roots
- •Patients on radiotherapy
- •Patients with systemic disorders
- •Patients with parafunctional habits
- •Patients with history of alcohol, drug dependency and smoking
结局指标
主要结局
Crestal bone level
时间窗: 6 months
Measured using CBCT scan both on mesial and distal sides .The coronal surface of the implant will be taken as reference line from where two perpendicular lines are dropped on both mesial and distal aspect of implants to first bone to implant contact.
Bone density
时间窗: 6 months
measured using CBCT scan using Hounsfield units at mid point of the implant both on mesial and distal side with coronal portion of implant as reference line.
次要结局
- Angular bleeding index(6 months)
- Peri-implant Probing pocket depth(6 months)
- Pink esthetic score(6 months)