NCT05824949已完成不适用
The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial
Arab American University (Palestine)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mechanical or primary stability
研究概览
简要总结
A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months,
- •(b) sufficient bone height (distance between the bone crest and maxillary sinus >8 mm) and width at the alveolar crest (≥6 mm) that would not necessitate bone augmentation,
- •(c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness,
- •(d) full-mouth plaque and bleeding scores <20%.
排除标准
- •patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded.
- •patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs
- •bone height <8mm
- •ridge and soft tissue deficiencies requiring augmentation procedures and
- •endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.
结局指标
主要结局
Mechanical or primary stability
时间窗: directly after implant placement
ISQ values at implant installation
Biological or secondary stability
时间窗: 4 months after implant installation
ISQ values at abutment connection
次要结局
- Torque value (N/cm)(directly after implant insertion)
研究者
Mahmoud Abu-Ta'a
Associate Professor
Arab American University (Palestine)
研究点 (1)
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