Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Implant stability quotient (ISQ)
研究概览
简要总结
For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat.
Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion.
The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability.
详细描述
Preoperative preparation:
A thorough preoperative assessment of all patients will be carried out including history taking, clinical examination and radiographic examination.
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● History: Each patient will be interviewed in order to obtain a comprehensive history.
● Clinical examination:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org). The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. patients will be randomly allocated to test and control groups using randomization schedule.
Masking/blinding:
- Participants will be blinded
- Blinding of the operator will be blinded
- The outcome assessor will be blinded
- The biostatistician will be blinded
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of extraction of a single, unrestorable tooth in the esthetic zone including maxillary anteriors and premolars
- •Age range between 20-60 years old
- •An intact buccal plate of bone after extraction
- •Medically free patients (Brightman. 1994)
- •Cooperative patients willing to follow up for the duration of the study.
排除标准
- •Acute infection in the implant site
- •Patients incapable of maintaining oral hygiene
- •Pregnant and nursing female patients
- •Smokers (more than 5 cigarettes per day)
- •A habit of bruxism
- •Periodontal disease
- •Subjects who have a systemic disease which affects bone healing as diabetes
- •Use of bone metabolism medicines; (Bisphosphonates) .
研究组 & 干预措施
Intervention: Osseodensification
Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow.
干预措施: Osseodensification drilling (Procedure)
Control: conventional drilling
Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow.
干预措施: Conventional drilling (Procedure)
结局指标
主要结局
Implant stability quotient (ISQ)
时间窗: 1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
resonance frequency analysis
次要结局
- Crestal bone level(day of the surgery (baseline), at 3 and 6 months postoperatively))
研究者
Omar Mostafa Ibrahim Omar
Principal Investigator
Cairo University