Evaluating the effect of osseodensification technique versus conventional technique of implant placement on bone marker (BMP-9) and clinical implant parameters: A Randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To analyse and compare levels of BMP-9 in peri-implant crevicular fluid (PICF) around implants placed using osseodensification (OD) drilling protocol and conventional drilling protocol.
研究概览
简要总结
Dental implants have revolutionised the field of oral rehabilitation with a success rate of 95% after 10 years of observational follow-ups1. However, in case of low bone density, such as upper human jaw, the insufficient bone around the implants could negatively influence the histomorphometric parameters (such as % BIC and % BV) and consequently their success rates.The relatively novel osteotomy preparation technique of osseodensification (OD) developed by Huwais in 2013, has prompted a paradigm shift in the implant site preparation techniques.2,3The conventional implant site preparation techniques are subtractive in nature, however osseodensification is non subtractive drilling technique using uniquely designed drills that rotate in a counterclockwise direction compacting bone at the osteotomy walls allowing more intimate engagement of the implant with the osteotomy site. OD technique has been based on the bone elastic and plastic properties which facilitate bone bulk preservation, resulting in the autografting of osseous material into the trabecular space and enhancing its density and also accelerating de novo bone formation at the implant site.
Despite the fact that many studies conducted on animal models have demonstrated a favourable outcome of osseodensification over conventional drilling technique, it’s clinical effect in human studies during the osseous healing is not clear. Also, little is known about the molecular events and crestal bone loss when using this technique.
Null hypothesis
It will be hypothesized no difference on bone markerBMP-9, implant stability and crestal bone loss will be found whether osseodensification drilling protocol or conventional drilling protocol is used for implant placement.
Objectives:
Primary objective- To analyse and compare levels of BMP-9 in peri-implant crevicular fluid (PICF) around implants placed using osseodensification (OD) drilling protocol and conventional drilling protocol
Secondary Objectives-
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To compare primary and secondary stability of implants placed using osseodensification drilling protocol and conventional drilling protocol.
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To compare the crestal bone loss around implants placed using osseodensification drilling protocol and conventional drilling protocol.
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To determine if any association exists between the levels of BMP-9 with implant stability and crestal bone loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group 18 and above and patient willing to participate in the study.
- •2.Patients with edentulous space in the maxillary jaw having healed bone site indicated for rehabilitation with implants.
- •3.Patient having sufficient residual bone volume for implant placement.
- •4.Patient having good general health with no systemic disease.
- •5.Patient having adequate oral hygiene.
排除标准
- •1.Patients with para functional habits such as bruxism and clenching.
- •2.Patients with local limitations such as inadequate inter-ridge distance.
- •3.Patients who consume alcohol, smoke or use illicit drugs.
- •4.Patient with any systemic disease, irradiated patients, patients with previous or active treatments with steroids or bisphosphonates.
结局指标
主要结局
To analyse and compare levels of BMP-9 in peri-implant crevicular fluid (PICF) around implants placed using osseodensification (OD) drilling protocol and conventional drilling protocol.
时间窗: 2 weeks, 8 weeks, 16 weeks
次要结局
- To compare primary and secondary stability of implants placed using Osseodensification drilling protocol and Conventional drilling protocol.(At the time of implant placement, 2 weeks, 8 weeks)
- To compare the crestal bone loss around implants placed using Osseodensification drilling protocol and Conventional drilling protocol.(Baseline, 2 weeks, 8 weeks, 16 weeks, 6 months)