The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
This study aims to determine the success of implant-borne prostheses and the accuracy of implant placement that can be achieved using fully guided static Computer Assisted Implant Surgery (sCAIS). Additional aims included the evaluation of the stability and health of hard and soft tissues, respectively surrounding the dental implants.
详细描述
Surgical planning A virtual planning software is used for surgical planning. Cone beam computed tomography (CBCT) reconstruction and intraoral scans are registered. Prosthetic plans are created in the software, or the radiological template was used as one. The angulation and position of the dental implants are determined by the prosthetic plan.
Surgical guides The surgical templates are manufactured by rapid prototyping (3D printing). To guide the drills for implant bed preparation sleeves are inserted in the surgical guides.
Surgical protocol Surgical interventions are performed by a single clinician experienced in dental implant placement and static navigation. Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. The fit of the surgical guide is checked under local anesthesia. Fully guided implant bed preparation is performed. Dental implants are placed non-submerged. Sutures are removed at 7 days postop. The prosthetic stages of treatment begin after a two-month healing period.
Prosthetic procedures Implant-borne overdentures are manufactured using a hybrid (analog-digital) workflow. An open tray impression is taken using a medium body silicone impression material to capture the position of the implant platforms. An overdenture and a bar mesostructure are manufactured by the dental laboratory with a precision attachment.
Fixed partial dentures (FPD) are manufactured using either a hybrid or a digital workflow. An open tray impression is taken using a medium body silicone impression material or postoperative intraoral scans are performed with scan bodies to capture the position of the implant platforms. Screw or cement-retained porcelain fused to metal FDPs are manufactured by the dental laboratory. Pre-contacts are finished using articulating papers until balanced occlusion in cases of overdentures or lateral guidance in cases of FPDs are obtained. Patients are recalled twice per year for controls and professional dental hygiene intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received implant-borne prostheses for oral rehabilitation.
- •Patients who had dental implants placed using fully guided sCAIS.
排除标准
- •patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV)
- •psychiatric contraindications
- •patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication
- •radiation to the head or neck region within the previous five years
- •localized periapical disease, including odontogenic and nonodontogenic cysts.
- •high and moderate patients with existing occlusal parafunction
- •evidence of uncontrolled periodontal disease
- •Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
- •recreational drug abuse
- •heavy smoking (>10 cigarettes/day),
- •diseases of the oral mucosa, including blisters and ulcers, red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer.
- •pregnancy or nursing
- •poor oral hygiene as determined by a modified plaque score >30%
- •unavailability for regular follow-ups.
结局指标
主要结局
Implant survival
时间窗: 5 years
The implant is present at the surgical site without signs of failure, mobility, and pain at the time of the follow-up
Implant success
时间窗: 5 years
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Success (optimum health) No pain or tenderness upon function 0 mobility less than 2 mm radiographic bone loss from initial surgery No exudates in the patient's history II. Satisfactory survival No pain on function 0 mobility 2-4 mm radiographic bone loss No exudates in the patient's history III. Compromised survival May have sensitivity on function No mobility Radiographic bone loss of more than 4 mm (less than half of the length of the implant body) Probing depth of more than 7 mm May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: Pain on function Mobility Radiographic bone loss of more than half length of the implant Uncontrolled exudate Implant no longer in mouth
Success of the implant borne prostheses
时间窗: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
次要结局
- Marginal Bone Loss (MBL)(5 years)
- Implant placement accuracy (Angular deviation)(2 months)
- Peri-implant mucositis(5 years)
- Peri-implantitis(5 years)
- Biomechanical complications(5 years)
- Intra-operative complications(at the time of the surgery)
- Implant placement accuracy (Apical Global Deviation)(2 months)
- Implant placement accuracy (Coronal Global Deviation)(2 months)
研究者
Marton Kivovics
associate professor
Semmelweis University