Implants Immediately Installed in Esthetic Area With Computer-guided Surgery: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Position of the implant
研究概览
简要总结
The objective of this randomized and longitudinal clinical study is to compare the installation of immediate implants in the esthetic zone through computer-guided-surgery and conventional surgery. To this end, 22 patients who need implant-supported replacement on the anterior region of the maxilla will be selected and after extraction will receive: Guided surgery (GS): installation of dental implant with the aid of the virtually planned guide by means of specific software; Conventional surgery (CS): installation of dental implant performed freehand using a conventional surgical guide made by study models.
详细描述
The objective of this randomized and longitudinal clinical study is to compare the installation of immediate implants in the esthetic zone through computer-guided-surgery and conventional surgery. To this end, 22 patients who need implant-supported replacement on the anterior region of the maxilla will be selected and after extraction will receive: Guided surgery (GS): installation of dental implant with the aid of the virtually planned guide by means of specific software; Conventional surgery (CS): installation of dental implant performed freehand using a conventional surgical guide made by study models. Tomographies will be performed 10 days after the surgery for the measurement of both linear and angular shifts between the installed implants and the virtual planning. All the clinical and radiographic assessments (Plaque and Bleeding Index, Drilling Depth, Relative Clinical Insertion Level and the Margin Position of Peri-Implant Mucosa) will be carried out after the surgery and within 6 and 12 months of post-operative. Assesments of the esthetic success (pink/white score) and survival and success of the implant will also be carried out. In the prosthetic part, it will be assessed the abutment mobility; corrective measures for the prothesis; repair on prothesis or abutment. The success and survival assessments of crowns will be done through structure fracture, occlusal roughness, marginal integrity and contour of the restoration. It will also be assessed the procedural impact in quality of life by applying a 36-closed-question-survey focused on appearence, pain, oral comfort, general performance, feeding and chewing. Subsequently, the data will be tabulated, and according to their distribution, the appropriate statistical tests will be applied, considering a 5% index of significance to all the analyses.
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 (Investigator, Outcomes Assessor)
盲法说明
Participating individuals will be allocated within each group through a computer-generated list, stored in a brown opaque envelope, under the care of an individual (TCB) other than the examiner. Only the professional responsible for the treatments will have access to the codes and both the patients and the examiners will be blind to the group to which each patient belongs, making possible the characterization of the study as double-blind.
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 sufficient bone volume availability apically and palatally that allows the correct positioning of the implants (Kan et al, 2011);
- •Implants with primary stability of 20-45 N (Gallucci et al, 2014);
- •Patients with teeth to be extracted in the Class I, II or III corono-radicular position, according to Kan et al. (2011);
- •Patients with distance from the bone crest to the point of contact in adjacent teeth less than or equal to 6.5mm (Buser et al 2017).
排除标准
- •Presence of diabetes, blood disorders and systemic diseases that prevent the surgical procedure;
- •History of radiotherapy in the head or neck region;
- •History of treatment with bisphosphonates;
- •Pregnant or lactating women;
- •Patients with teeth to be extracted in the Class V corono-radicular position, according to Kan et al. (2011);
- •Gingival recession in the teeth indicated for exodontia (Kan et al, 2001);
- •Acute infection at the implant site (Morton et al, 2014);
- •Unavailability to attend the FOP / UNICAMP on the pre-determined days.
结局指标
主要结局
Position of the implant
时间窗: Baseline, 10 days
Difference between angular position of the implant by computer software and angular position of the implant by free hand.
次要结局
- Peri-implant probing depth(Immediately after surgery, 6 months, 12 months)
- Relative gingival margin position(Immediately after surgery, 6 months, 12 months)
- Relative clinical attachment level(Immediately after surgery, 6 months, 12 months)
研究者
Enilson Antonio Sallum
Full professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil
University of Campinas, Brazil