Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.
详细描述
General operative procedures:
Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).
Patients of both groups will be subjected to:
Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.
Intraoperative procedure:
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)
盲法说明
Due to the nature of the trial only the outcome assessor will be masked from the intervention or control group
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.
- •Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.
- •Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.
- •Presence of adjacent teeth to the tooth or remaining root to be extracted.
排除标准
- •Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.
- •Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.
- •Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis...)
结局指标
主要结局
Patient satisfaction
时间窗: 0-6 months
Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
次要结局
- Early implant failure(0-6 months)
研究者
Safaa Kamel Hussein
Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator
Cairo University