Clinical and Digital Outcomes of Silicate-Added β-TCP Putty and Extended Sticky Bone for Peri-Implant Jumping Gap Management Following Fully Guided Immediate Implant Placement in the Maxillary Esthetic Zone: A Randomized Clinical Trial
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
- Implant Stability
研究概览
简要总结
This randomized clinical trial compares three peri-implant jumping gap management approaches following fully guided immediate implant placement in the maxillary esthetic zone. Clinical and digital outcomes will be evaluated after immediate provisionalization and final restoration.
详细描述
Seventy two patients will be randomly assigned to receive no graft, silicate-added β-TCP putty, or extended sticky bone for jumping gap management around immediately placed implants. A CAD/CAM provisional crown will be delivered immediately, and the final prosthesis will be placed after 3 months.
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
- Single (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.
- •Age range: from18 to 50 years.
- •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.)
- •Pregnancy.
- •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
Fully guided immediate implant placement with an ungrafted peri-implant jumping gap and immediate CAD/CAM provisionalization.
干预措施: No Grafting (Procedure)
Study Group 1 (Si-β-TCP Putty Group)
Fully guided immediate implant placement with a peri-implant jumping gap filled using silicate-added β-TCP putty and immediate CAD/CAM provisionalization.
干预措施: Silicate-Added β-TCP Putty (Procedure)
Study Group 2 (Extended Sticky Bone Group)
Fully guided immediate implant placement with a peri-implant jumping gap filled using extended sticky bone and immediate CAD/CAM provisionalization.
干预措施: Extended Sticky Bone (Procedure)
结局指标
主要结局
Implant Stability
时间窗: Immediate post-operative, 3 months, and 6 months.
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
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
- Soft Tissue(Baseline, 1 month, 3 months, and 6 months.)