Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: 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
- 60
- 试验地点
- 1
- 主要终点
- Peri-implant soft tissue changes
研究概览
简要总结
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.
详细描述
Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone. Clinical and peri-implant soft tissue outcomes will be evaluated.
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 presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.
- •Age ranging from 18 to 50 years.
- •Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.
- •Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases.
- •Good oral hygiene and periodontal health.
- •Willingness to attend all follow-up visits and comply with study requirements.
排除标准
- •Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.
- •Alcohol or drug abuse.
- •Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).
- •Pregnancy or lactation.
- •Patients with parafunctional habits such as bruxism or clenching.
- •Inability to maintain adequate oral hygiene or attend follow-up visits.
研究组 & 干预措施
Study Group 1 (3D-Printed resin Group)
Thirty patients received a digitally designed 3D-printed resin immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
干预措施: 3D-Printed Resin Provisional Crown (Procedure)
Study Group 2 (CAD/CAM-Milled PMMA Group)
Thirty patients received a digitally designed CAD/CAM-milled PMMA immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
干预措施: CAD/CAM-Milled PMMA Provisional Crown (Procedure)
结局指标
主要结局
Peri-implant soft tissue changes
时间窗: Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
次要结局
- Pink Esthetic Score (PES)(After 3 and 6 months postoperatively.)
- Implant stability(Immediate post-operative and at 3 months.)