Optimizing Alveolar Ridge Expansion: A Clinical Comparison of Magneto-Dynamic Ridge Splitting and Versah Osseodensification Techniques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Alveolar Ridge Width (Buccolingual Dimension)
研究概览
简要总结
The goal of this clinical trial is to compare two surgical techniques-Magneto-Dynamic Ridge Splitting and Versah Osseodensification-for expanding narrow alveolar ridges in adults requiring dental implant placement. The main questions it aims to answer are:
Which technique better preserves alveolar bone width after surgery?
Which method results in higher primary implant stability?
Researchers will compare ridge splitting using the Magnetic Mallet to ridge expansion using Versah drills to see if one technique leads to better clinical outcomes, such as improved bone preservation, greater implant stability, and favorable soft tissue response.
Participants will:
Undergo ridge expansion surgery using either the Magnetic Mallet or Versah drills, followed by immediate dental implant placement.
Receive CBCT scans before and 4 months after surgery to measure bone changes.
Undergo implant stability testing using the ISQ (Implant Stability Quotient) method.
Have intraoral scans to evaluate changes in soft tissue volume and thickness.
详细描述
This clinical trial aims to evaluate and compare two innovative techniques used to widen narrow jawbone areas (alveolar ridges) in preparation for dental implants. In many patients, the bone in the jaw may be too thin to support dental implants without additional procedures. Traditionally, this problem has been addressed using more invasive surgical methods that can involve bone grafting and extended healing times.
The two techniques being studied are:
Magneto-Dynamic Ridge Splitting (Magnetic Mallet) - This method uses gentle electromagnetic impulses to gradually split and expand the bone. The technique is minimally traumatic, preserves the outer bone layer (cortical bone), and may promote better healing and stability for implants.
Osseodensification (Versah Drills) - This technique uses specially designed rotating drills (Densah burs) that do not remove bone but instead compact it outward, increasing its density. This approach is designed to strengthen the implant site and improve how well the implant integrates with the bone.
The study is a randomized controlled clinical trial conducted at Hawler Medical University. Participants will be randomly assigned to one of the two groups. Both groups will receive immediate implant placement following the ridge expansion procedure, using the same implant system (ROOTT Implants).
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years.
- •Partially edentulous patients requiring ridge expansion prior to dental implant placement.
- •Alveolar ridge width between 4 mm and 6 mm as measured on CBCT.
- •Sufficient vertical bone height for implant placement without the need for vertical augmentation.
- •Adequate oral hygiene and commitment to postoperative care and follow-up visits.
- •Signed informed consent form.
排除标准
- •Presence of systemic conditions contraindicating oral surgery (e.g., uncontrolled diabetes, immune-compromised status).
- •History of bisphosphonate therapy or radiation therapy to the head and neck region.
- •Active periodontal disease or untreated oral infections.
- •Heavy smokers (more than 10 cigarettes per day).
- •Pregnant or breastfeeding women.
- •History of substance abuse or psychiatric disorders that could impair compliance with study protocol.
研究组 & 干预措施
Magneto-Dynamic Ridge Splitting
Participants in this arm will undergo ridge expansion using the Magnetic Mallet system. The procedure involves magneto-dynamic impulses to laterally expand the alveolar ridge prior to dental implant placement.
干预措施: Magneto-Dynamic Ridge Expansion (Procedure)
Versah Osseodensification
Participants in this arm will undergo ridge expansion using Versah drills (Densah burs) in osseodensification mode prior to dental implant placement.
干预措施: Osseodensification with Versah Drills (Procedure)
结局指标
主要结局
Change in Alveolar Ridge Width (Buccolingual Dimension)
时间窗: Baseline (pre-operative) and 4 months post-surgery
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
Change in Alveolar Ridge Width (Buccolingual Dimension)
时间窗: 4 Months
Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.
次要结局
未报告次要终点
研究者
Abduljaleel Azad Koyi
Optimizing Alveolar Ridge Expansion: A Clinical Comparison of Magneto-Dynamic Ridge Splitting and Versah Osseodensification Techniques
Hawler Medical University