Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- horizontal labio-palatal bone collapse
研究概览
简要总结
For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with & without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult (>20 years) with non-restorable maxillary teeth in the esthetic zone,
- •thick gingival phenotype,
- •intact but thin labial plate of bone (≤1mm)
- •intact palatal bone extending at least 6mm apically,
- •sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
- •labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.
- •patients agreed to sign a written informed consent.
排除标准
- •pregnant women,
- •patients with systemic disease,
- •patients with parafunctional habits such as bruxism or clenching,
- •infected socket,
- •periapical pathosis
- •history of radiotherapy or chemotherapy within the past 2 years.
研究组 & 干预措施
immediate implant placement without bone grafting
After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface.
干预措施: immediate implant placement without bone grafting (Procedure)
immediate implant placement with bone grafting
After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface.
干预措施: immediate implant placement with socket bone grafting (Procedure)
结局指标
主要结局
horizontal labio-palatal bone collapse
时间窗: 1 year
CBCT superimposition (fusion scans)
Amount of bone labial to the implant
时间窗: 1 year
CBCT superimposition (fusion scans)
Horizontal labio-palatal bone width
时间窗: 1 year
CBCT superimposition (fusion scans)
vertical bone dimensional changes
时间窗: 1 year
CBCT superimposition (fusion scans)
次要结局
- Postoperative Pain(1 day, 3 days, 7 days)
- gingival index(1 year)
- Implant failure(1 year)
- Plaque Index(1 year)
研究者
Nesma Mohamed Fouad Shemais
Lecturer in the department of Oral Medicine & Periodontology
Cairo University