Clinical Outcomes of Immediately Loaded Implants With Buccal Dehiscence Treated by Horizontal Augmentation Compared With Immediately Loaded Implants Without Regeneration Techniques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Implant Success Rate
研究概览
简要总结
This study aims to compare the clinical success and patient-reported outcomes of immediately loaded dental implants placed in sites with buccal dehiscence treated by horizontal augmentation versus immediately loaded implants placed without regeneration techniques.
详细描述
This is a prospective, interventional, non-randomized, comparative clinical trial designed to evaluate the clinical outcomes of immediately loaded dental implants using two different surgical approaches. One group will receive implants placed in sites with buccal dehiscence treated by horizontal bone augmentation, while the comparison group will receive immediately loaded implants placed without the use of any bone regeneration techniques.
The primary outcome of the study is implant success at 12 months after implant placement. Secondary outcomes include marginal bone level changes, complication rates, and oral health-related quality of life assessed using a validated questionnaire. The study is conducted with a parallel assignment model and an open-label design due to the nature of the surgical interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients requiring dental implant placement Presence of buccal dehiscence at the implant site Indication for immediate loading Ability to provide written informed consent
排除标准
- •Uncontrolled systemic diseases Active periodontal disease Heavy smoking exceeding predefined limits Conditions contraindicating oral surgery
研究组 & 干预措施
Horizontal bone augmentation associate with immediate loading
Horizontal bone augmentation associate with immediate loading
干预措施: guided bone regeneration technique (Procedure)
Inmediate Loading without bone regeneration technique
Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.
干预措施: No intervention (Procedure)
结局指标
主要结局
Implant Success Rate
时间窗: 12 months after implant placement
Implant success is defined as implant survival at 12 months, absence of clinical mobility, absence of persistent pain or infection, absence of peri-implant radiolucency, and no need for implant removal or surgical re-intervention.
次要结局
未报告次要终点