Evaluating the Effect of Bone Morphogenetic Protein on Dental Implant Stability and Marginal Bone Level Following Immediate Implant Placement (Randomized Controlled Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effect of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) on the stability and marginal bone level of dental implants following immediate placement.
patients requiring extraction of unrestorable tooth in upper incisors or premolar region will be randomly assigned into two groups: the experimental group will receive immediate implant placement with rhBMP-2 application, while the control group will receive immediate implant placement without rhBMP-2.
each group includes 16 immediate implants. Implant stability will be assessed using resonance frequency analysis (RFA) at baseline, and 16 weeks after implant placement. Marginal bone level changes will be evaluated radiographically using cone beam computed tomography (CBCT).
The study aims to determine whether the use of rhBMP-2 enhances osseointegration and reduces marginal bone loss compared with conventional immediate implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients ≥18 years of either sex
- •Having a single or multiple unrestorable maxillary anterior and premolar teeth indicated for extraction
- •Jumping gap ≥2 mm
- •Apical bone ≥3 mm from the vertical structure beyond the apex
- •Willing to comply with the study and provide informed consent
- •Good oral hygiene
排除标准
- •Active infection or inflammation in implant area
- •Uncontrolled diabetes or coagulation disorders
- •Immunocompromised patients
- •Patients treated with bisphosphonate drugs
- •Psychiatric problems
- •Pregnant women
- •Medical conditions affecting bone healing
- •Clinical evidence of parafunctional habits
- •Heavy smokers (≥20 cigarettes/day)
研究组 & 干预措施
Experimental: rhBMP-2 Group
Immediate dental implant placement with application of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) with bone graft in jumping gap.
干预措施: rhBMP-2 placement (Biological)
Control: standard immediate implant
Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein.
干预措施: conventional immediate implant (Device)
结局指标
主要结局
Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis
时间窗: Baseline and 16 weeks after implant placement
Evaluation of implant stability using resonance frequency analysis (RFA) device to measure the Implant Stability Quotient (ISQ) at baseline and 16 weeks after implant placement.
次要结局
- Marginal Bone Level (MBL) Changes around Dental Implants(Baseline and 16 weeks after implant placement)
研究者
Aya Adil Saeed
principal investigator
University of Baghdad