Evaluation of the effect of Recombinant Human Bone Morphogenic Protein-2 on crestal bone height and osseointegration around endosseous implants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the implant stability around implants coated with rhBMP-2 gel.
研究概览
简要总结
BMPs are growth factors, belonging to the transforming growth factor-β family, which induces new bone formation by stimulating the differentiation of multipotent cells. They are osteoinductive in nature. Though 20 types of BMP were identified, BMP-2, 7, 8 and 9 were proved effective in enhancing osteogenic activity; and BMP 2 and 7 are approved for human use promoting bone cell migration, differentiation, and proliferation to enable bone remodeling around the implant.
Patient selection will be done after the assessment of eligibility criteria. In Phase I therapy oral prophylaxis and surgical stunt fabrication will be done. And patient will be recalled after 1 week for surgical procedure.The procedure will be performed under local anesthesia using 2% lignocaine containing adrenaline 1:80,000.A midcrestal incision will be given in both cases. A mucoperiosteal flap will be elevated and osteotomy site will be prepared. In Group 1 patients, implants will be placed without rhBMP-2 gel coating and in Group 2 implants will be coated with rhBMP-2 gel. After placement, stability will be checked with RFA at baseline.Cover screw will be given following the implant placement and flaps will be approximated and sutured. Patient will be recalled after 3 months and 6 months for evaluation of parameters like RFA and IOPA.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals with an age group of 25-50 years of either gender.
- •2.Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
- •3.Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
- •4.Apparently healthy individuals.
- •5.Individuals with bone density classified as D2 and D3 type of bone.
排除标准
- •1.Any forms of tobacco users.
- •2.Pregnant and lactating women.
- •3.Subjects taking any medication which effect healing and bone metabolism.
- •4.Individuals with parafunctional habits.
- •5.History of radiotherapy to head and neck.
结局指标
主要结局
To evaluate the implant stability around implants coated with rhBMP-2 gel.
时间窗: Baseline and 3 months
次要结局
- To evaluate the crestal bone level around implants coated with rhBMP-2 gel.(Baseline ,3 months and 6 months)
研究者
Moturi Padmini Raj
Sibar Institute of Dental Sciences