Osseo-densification Versus Conventional Drilling for Dental Implant Placement: A Double-Blinded Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Bone density
研究概览
简要总结
Primary implant stability and bone preservation are critical determinants of successful osseointegration, particularly in sites with low bone density. Conventional drilling removes bone and may reduce stability, whereas osseo-densification is a non-subtractive technique that compacts bone to enhance its density and strength.
Objective:
To compare osseo-densification and conventional drilling techniques in terms of implant primary stability, peri-implant bone density, and marginal bone loss during early healing.
Methods:
A double-blinded, randomized split-mouth clinical trial was conducted on eight participants requiring bilateral maxillary implants (n = 16 sites). Each patient received one implant using the osseo-densification technique (Densah burs, counterclockwise mode) and one using conventional sequential drilling. Cone-beam computed tomography (CBCT) was used to evaluate bone density and marginal bone levels at baseline, three, and six-months post-placement. Implant stability was measured immediately after insertion using resonance frequency analysis (Osstell ISQ). Data were analysed using t-tests and repeated-measures ANOVA (p < 0.05).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Systemically and medically healthy adults (>18 years old) of either sex.
- •Presence of a single missing tooth in the anterior or posterior maxilla with a minimum alveolar bone width of 6 mm, indicated for delayed implant placement.
- •Bone quality corresponding to D3-D4 density as determined by cone-beam computed tomography (CBCT).
- •Adequate keratinized mucosa of at least 3 mm in width (measured from the gingival margin to the mucogingival junction).
- •Intact buccal periodontal tissues, including bone, soft tissue, and ligament integrity.
- •Good oral hygiene and compliance with follow-up visits.
排除标准
- •• Systemic medical conditions that could compromise surgical healing or osseointegration (e.g., uncontrolled diabetes mellitus).
- •Regular use of medications known to interfere with bone metabolism or healing, such as anticoagulants, antiplatelet agents, or systemic glucocorticoids.
- •Pregnancy or lactation in female participants.
- •Heavy smoking habits (>10 cigarettes per day), alcohol abuse, or recreational drug use.
- •Current or previous history of periodontal disease affecting adjacent teeth.
- •Active periodontal or periapical infection at the intended implant site.
研究组 & 干预措施
Osseodensification
干预措施: Osseodensification (Procedure)
Conventional drilling
干预措施: Conventional drilling (Procedure)
结局指标
主要结局
Bone density
时间窗: Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.
Assessed by 3D Cone Beam Computed Tomography
次要结局
- Marginal bone height(Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.)