NCT06780956已完成3 期
Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.
Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Marginal bone loss (MBL)
研究概览
简要总结
Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.
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, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without any systemic pathologies that could be considered grounds for absolute contraindication.
- •Adult patients who agreed to participate in the study and signed the informed consent form.
- •Patients who smoked fewer than ten cigarettes per day.
- •Patients who were not completely edentulous.
- •Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.
- •Patients with an area of healed, mature bone at least three months post-extraction.
排除标准
- •Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).
- •Patients who smoked more than ten cigarettes per day.
- •Patients with a bleeding index greater than 30%.
- •Patients with dental caries or periodontal disease.
- •Pregnant or lactating women.
研究组 & 干预措施
conventional
Active Comparator
Conventional Drilling Protocol
干预措施: Conventional (Other)
simplfied
Experimental
simplfied drilling protocol
干预措施: simplfied (Other)
结局指标
主要结局
Marginal bone loss (MBL)
时间窗: 24 month
Is a non-infective remodeling process of variable entity occurring after implant placement.
次要结局
未报告次要终点
研究者
Artiom Lijnev
MSc
San Antonio Technologies - San Antonio Catholic University of Murcia
研究点 (1)
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