Clinical Comparative Analysis of Magnetic Mallet and Conventional Drilling Techniques for Implant Placement in D4 Bone: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- implant stability
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the magnetic mallet technique improves primary implant stability and clinical outcomes compared with conventional drilling during dental implant placement in the posterior maxilla with soft bone quality.
The main questions it aims to answer are:
Does the magnetic mallet technique result in higher primary implant stability compared with conventional drilling?
Does the magnetic mallet technique reduce surgical trauma and related complications compared with conventional drilling?
Researchers will compare the magnetic mallet technique with conventional drilling to determine differences in implant stability, bone response, and clinical outcomes.
Participants will:
Undergo dental implant placement using either the magnetic mallet technique or conventional drilling.
Be clinically and radiographically evaluated for implant stability and postoperative outcomes during follow-up
详细描述
This study is a prospective clinical trial designed to compare the magnetic mallet technique with conventional drilling for dental implant placement in the posterior maxilla characterized by soft bone quality (D4 bone). Achieving adequate primary implant stability in this region remains a clinical challenge, and techniques that preserve and condense bone may improve treatment outcomes.
The magnetic mallet technique uses controlled electromagnetic impulses to prepare the implant site through bone condensation rather than bone removal, potentially enhancing primary stability and reducing surgical trauma. In contrast, conventional drilling relies on rotational cutting instruments that remove bone and may generate heat, which can negatively affect bone vitality.
Eligible participants requiring dental implants in the posterior maxillary region will be randomly allocated to one of two groups: implant site preparation using the magnetic mallet technique or conventional drilling. All implants will be placed following standardized surgical protocols.
Primary outcomes will include the assessment of primary implant stability using objective measurement methods. Secondary outcomes will evaluate peri-implant bone response, intraoperative and postoperative complications, and overall clinical performance during follow-up.
The results of this study aim to provide clinical evidence regarding the effectiveness and safety of the magnetic mallet technique compared with conventional drilling, particularly in soft posterior maxillary bone, to support evidence-based decision-making in implant dentistry
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 (Outcomes Assessor)
盲法说明
The outcome assessor is blinded to the implant site preparation technique used in each participant to minimize assessment bias. Due to the nature of the surgical interventions, masking of the surgeon and participants is not feasible.
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
- •where: patients with
- •healed edentulous posterior maxilla
- •residual vertical bone height ≥ 11 mm, allowing implant placement without sinus augmentation
- •bone quality classified as Type IV (D4) according to the Lekholm and Zarb classification
排除标准
- •where: patients with Systemic diseases affecting bone healing, active oral infection, smoking habits, or a need for bone augmentation procedures were excluded.
研究组 & 干预措施
Conventional Drilling Group
participants in this arm will undergo implant site preparation using the conventional drilling osteotomy technique according to standard clinical protocols before dental implant placement.
干预措施: This study includes two device-based interventions: conventional drilling osteotomy and magnetic mallet osteotomy for implant site preparation prior to dental implant placement. (Device)
Magnetic Mallet Group
participants in this arm will undergo implant site preparation using the magnetic mallet osteotomy technique, which prepares the implant site through controlled bone condensation prior to dental implant placement.
干预措施: This study includes two device-based interventions: conventional drilling osteotomy and magnetic mallet osteotomy for implant site preparation prior to dental implant placement. (Device)
结局指标
主要结局
implant stability
时间窗: immediately after implant placement and at 3 months postoperatively
Implant stability was assessed using Implant Stability Quotient (ISQ) values
次要结局
- postoperative pain(7 days after surgery)
研究者
Alyaa Ismael Naser
Assistant Professor Dr Alyaa Ismael Naser
University of Mosul