Comparative Evaluation of Three-Dimensional Volumetric Bone Formation and Bone Density Following an Indirect Sinus Floor Augmentation with Injectable Platelet Rich Fibrin (I-PRF) and Alloplastic Graft Material
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 evaluate volumetric bone formation and bone density following indirect sinus floor augmentation using Injectable Platelet Rich Fibrin (I-PRF), alloplastic graft and with no graft material.
研究概览
简要总结
The aim of this study is to analyse the volume and density of the endo-sinus bone after maxillary sinus augmentation with I-PRF and alloplastic graft material using cone beam computed tomography (CBCT) scan after 6 months. The study will include 30 participants within the age range of 19-60 years, who are willing to undergo implant placement for the rehabilitation of missing teeth in the deficient posterior maxilla and have a residual bone height and width of 4-6 mm and 6-8 mm, respectively.
Participants will be informed about the details of the study, and a participant information sheet and informed consent form will be signed by them prior to the study. All the surgical procedure will be carried out by a single trained clinician. Appropriate implant will be selected and placed depending on the participant’s native bone, including width and height. Once the data is obtained, it will be used to compare the endo-sinus bone volume and density following indirect sinus augmentation using I-PRF, alloplastic graft and with no graft material.
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 with a healed alveolar ridge with missing premolar or molar in the maxilla
- •Residual bone height of 4 to 6 mm
- •Crestal bone width of 6 to 8 mm
- •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 evaluate volumetric bone formation and bone density following indirect sinus floor augmentation using Injectable Platelet Rich Fibrin (I-PRF), alloplastic graft and with no graft material.
时间窗: Before treatment and after six months
次要结局
- To compare the endo-sinus bone volume and density following indirect sinus augmentation using Injectable Platelet Rich Fibrin (I-PRF), alloplastic graft and with no graft material(Before treatment and after six months)
研究者
Dr Nafiya Abdul Aziz
Yenepoya Dental College