Evaluation of Silicate-Added Beta-Tricalcium Phosphate Putty in Fully-Guided Immediate Implants in the Esthetic Zone Using Customized Healing Abutment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hard Tissue (Peri-implant bone)
研究概览
简要总结
This study aims to evaluate bone and soft tissue changes clinically and digitally after using a customized healing Abutment with or without silicate-added beta-tricalcium phosphate (Si-β-TCP) putty.
详细描述
Fully guided immediate implant placement in the esthetic zone presents challenges related to soft tissue closure, jumping gap management, and peri-implant stability. The use of silicate-added β-TCP putty with customized healing abutments has been proposed to improve soft tissue healing and maintain peri-implant architecture.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction.
- •Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration.
- •Jumping gap more than 2mm.
- •Patients with good oral hygiene.
- •Patients willing to participate in the study's follow-up intervals.
排除标准
- •Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
- •Alcohol or drug abuse.
- •Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.)
- •Patients with para-functional habits (bruxism and clenching).
- •Lack of motivation or inability to maintain good oral hygiene.
研究组 & 干预措施
Control group
Immediate implant placement with customized healing abutment without Si-β-TCP putty in the esthetic zone.
干预措施: Conventional healing/ No graft (Procedure)
Study group (Si-β-TCP Putty Group)
Immediate implant placement with silicate-added beta-tricalcium phosphate putty and customized healing abutment in the esthetic zone.
干预措施: Silicate-added β-TCP putty for jumping gap grafting (Procedure)
结局指标
主要结局
Hard Tissue (Peri-implant bone)
时间窗: - Immediately after implant placement - 6 months after implant placement
Marginal bone loss will be assessed using CBCT measured in mm.
次要结局
未报告次要终点