Comparative evaluation of the effects of injectable-platelet rich fibrin (I-PRF) and synthetic graft on the implant stability following indirect sinus augmentation
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
- To assess the implant stability following indirect sinus augmentation using Injectable-Platelet Rich Fibrin (I-PRF), synthetic graft and without graft
研究概览
简要总结
This study aims to assess and compare the effects of Injectable-Platelet-Rich Fibrin(I-PRF) and synthetic graft on the implant stability following indirect sinus augmentation. The study will include 30 participants with missing maxillary posterior teeth and a minimum of 4mm residual bone height and 6mm crestal bone width. Participants will be divided into 3 groups of 10 each. In Group 1, participants will undergo sinus membrane elevation without graft. For Group 2, participants will undergo sinus membrane elevation and Injectable-Platelet Rich Fibrin (I-PRF) will be used for augmentation. In Group 3, participants will undergo sinus membrane elevation and synthetic graft material will be used for augmentation. Appropriate implant will be selected and placed depending on the parameters of the participant’s native bone. Implant stability will be measured using resonance frequency analysis (RFA) device at the time of implant placement and at 6 months. The values will be noted in the data collection sheet. Statistical analysis will be done accordingly and obtained data will be used to find the association between 3 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be selected using the following criteria:
- •Healed edentulous ridge in the maxillary pre-molar or molar region.
- •Residual bone height ranging from 4 to 6 mm.
- •Crestal bone width ranging from 6 to 8 mm.
- •Maintaining Good oral hygiene.
排除标准
- •Systemic conditions such as uncontrolled diabetes mellitus, hypertension and bleeding disorder
- •Presence of active sinusitis
- •Sinus membrane thickening of more than 2mm
- •Patients on long term steroid therapy or bisphosphonate medication
- •Any previous history of sinus surgery
- •Untreated active periodontitis in neighbouring teeth
- •Participants who are current smokers
- •Pregnant women and nursing mothers.
结局指标
主要结局
To assess the implant stability following indirect sinus augmentation using Injectable-Platelet Rich Fibrin (I-PRF), synthetic graft and without graft
时间窗: at baseleine, at 6 months after implant placement
次要结局
- To compare the stability of the implant following indirect sinus augmentation using Injectable-Platelet Rich Fibrin (I-PRF), synthetic graft & without bone graft.(At baseline & after 6 months after implant placement)
研究者
Dr Sunaina M
Yenepoya Dental College