Implant Placement Accuracy and Clinical Outcomes of Sleeved Versus Sleeveless Static Surgical Guides for Immediate Implant Placement in the Premolar Region: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Global Coronal Deviation
研究概览
简要总结
This study aims to compare implant placement accuracy using sleeved versus sleeveless static surgical guides for immediate implant placement in the premolar region.
详细描述
This randomized controlled clinical trial will evaluate the accuracy of immediate implant placement using sleeved versus sleeveless static surgical guides in the premolar region.
A total of 80 immediate implants will be placed, with 40 implants allocated to each group.
The surgical protocol, implant system and dimensions, drilling protocol, and postoperative care will be standardized.
Implant placement accuracy will be assessed by comparing the planned and actual implant positions.
Coronal, apical, and angular deviations, as well as overall implant placement accuracy, will be evaluated between the two groups.
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
- 是
入选标准
- •Patients with non-restorable teeth in premolar area 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
Study Group 1 (Sleeved Guide)
40 immediate dental implants will be placed using a conventional sleeved static surgical guide in the maxillary premolar region. Silicate-added β-tricalcium phosphate graft will be used to fill the peri-implant gap, followed by placement of a provisional crown.
干预措施: Conventional Sleeved Static Surgical Guide (Procedure)
Study Group 2 (Sleeveless Guide)
40 immediate dental implants will be placed using a sleeveless static surgical guide in the maxillary premolar region. Silicate-added β-tricalcium phosphate graft will be used to fill the peri-implant gap, followed by placement of a provisional crown.
干预措施: Sleeveless Static Surgical Guide (Procedure)
结局指标
主要结局
Global Coronal Deviation
时间窗: Immediately after implant placement.
The deviation between the planned and actual implant positions at the coronal point will be assessed using CBCT superimposition, measured in mm.
Global Apical Deviation
时间窗: Immediately after implant placement.
The deviation between the planned and actual implant positions at the apical point will be assessed using CBCT superimposition, measured in mm.
Angular Deviation
时间窗: Immediately after implant placement.
The angular deviation between the planned and actual implant axes will be assessed using CBCT superimposition, measured in degrees (°).
Vertical (Depth) Deviation
时间窗: Immediately after implant placement.
The deviation in implant depth between the planned and actual implant positions will be assessed using CBCT superimposition, measured in mm.
次要结局
- Surgical Time(During the surgical procedure.)
- Prosthetic fit of the prefabricated 3D-printed restoration(Immediately after provisional crown placement.)
- Ease of Guide Use (Operator Assessment)(Immediately after implant placement.)
- Conversion to Freehand Surgery(During implant placement.)
- Intraoperative Patient Comfort(Immediately after implant placement.)