Immediate Restoration of a New Implant With High Primary Stability: A 1-year Follow-up - Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Implant survival rate
研究概览
简要总结
The main objective of this scientific study is to evaluate the short-term (1-year) survival and success rates of dental implants restored immediately compared to implants restored after a three-month healing period.
The total duration of the study is 12 months following implant placement, during which clinical and radiographic evaluations will be carried out at different follow-up time points.
详细描述
The present study aims to prospectively and in a controlled manner evaluate the short-term (1-year) survival and success rates of immediately restored dental implants compared with implants restored after a three-month healing period.
The study will be conducted at the Faculty of Dental Medicine of the University of Porto, under the coordination of Professor Ricardo Faria de Almeida, in collaboration with MIS Implants Technologies Ltd.
Working Hypothesis The null hypothesis of the present study states that both clinical groups will present similar implant survival rates at the end of one year of follow-up.
Materials and Methods Study Design The present study was designed as a non-interventional, prospective, randomized, controlled clinical study with two parallel groups, intended to compare the clinical and radiographic performance of implants rehabilitated with immediate loading versus implants rehabilitated after a three-month healing period.
Outcome Variables
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 70 years of age.
- •Ability to read, understand, and sign the informed consent form.
- •Need for placement of one or more implants for fixed prosthetic rehabilitation in either arch.
- •Insertion torque ≥ 35 Ncm (lower values will be excluded from the study).
- •Adequate bone dimensions to receive an implant with diameter ≥ 3.75 mm and length ≥ 10 mm.
- •Bone type I to III at the insertion site.
- •Good oral hygiene: FMBS and FMPS ≤ 25%.
- •Systemic status classified as ASA I or II.
排除标准
- •Inability to attend follow-up appointments.
- •Systemic contraindications to oral surgery (ASA III or IV).
- •Pregnancy or breastfeeding.
- •Chronic use of corticosteroids, bisphosphonates, or RANKL inhibitors within the last year.
- •Alcohol or drug abuse.
- •Heavy smoking (≥ 10 cigarettes/day).
- •Previous radiotherapy in the cervicofacial region.
- •Untreated active periodontal disease.
- •Absence of antagonist teeth.
- •Local pathology at the planned implant site.
- •Uncontrolled diabetes mellitus (HbA1c > 7%).
- •Bone type IV at the surgical site.
研究组 & 干预措施
Test group - Implant restoration with a temporary crown
Immediately after surgery, the implants of the test group will receive temporary restoration with a screw-retained pre-prepared temporary crown. It will be bound to a temporary titanium temporary abutment for CONNECT. Occlusion will be checked to avoid complete occlusal contact with the antagonist teeth in static and dynamic relationships. Afterward, it will be finished, polished, and screwed to the Connect (hand screwdriver).
干预措施: Test group - Implant restoration with a temporary crown (Device)
Control Group - Healing abutment on implant
A healing abutment of no more than one mm above the soft tissue will be attached to the Connect with a hand screwdriver.
干预措施: Control Group (Device)
结局指标
主要结局
Implant survival rate
时间窗: - Immediately after placement (Visit 1) - confirm placement - 10-14 days post-op (Visit 2) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
Any implant removed after placement will be considered a failure, whatever the reason. Implant survival will be evaluated clinically and radiographically by counting the remaining implants. The implant survival rate will be calculated by dividing the number of non-failures by the number of installed implants. In addition, the implant survival rate will be calculated at the patient level and on an implant level.
次要结局
- Implant success rate(- Immediately post-insertion (Visit 1) - 10-14 days post-op (Visit 2) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- Prosthetic success(- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- Implant insertion torque(Immediately at implant placement (Visit 1))
- Marginal bone changes(- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- A pink esthetic score/white esthetic score (PES/WES)(- 12 months ±2 weeks (Visit 6))
- 7.1 Clinical measurements - Gingival index(- Screening (Visit 0b) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- 7.2 Clinical measurements - Probing Pocket depth (PPD(3 months ±14 days (Visit 3) 6 months ±2 weeks (Visit 5) 12 months ±2 weeks (Visit 6)])
- 7.3 Clinical measurements - Bleeding on Probing(3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- 7.4 Clinical measurements (using UNC periodontal probe)(3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))
- Safety Measurements - Avaluation(- Immediately post-insertion (Visit 1) - 10-14 days post-op (Visit 2) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6))