A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Buccal bone thickness -1 (mm)
研究概览
简要总结
The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach.
The main questions it aims to answer are:
Primary:
How much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder?
Secondary:
- How do patients rate pain, healing, and esthetics after treatment?
- Are there any complications over the course of five years?
- How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder?
- Marginal bone loss at one-year and five-year follow-up?
- Peri-implant health at one-year and five-year follow-up?
- Soft tissue changes at one-year and five-year follow-up?
Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.
Participants will:
- Receive a dental implant and temporary crown on the same day as the tooth extraction
- Undergo guided, flapless surgery with bone and soft tissue grafting
- Take antibiotics and anti-inflammatories for 4 days after surgery
- Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams
- Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes
- Answer questions about pain and esthetic satisfaction
详细描述
Preoperative three-dimensional radiograph and intra-oral digital impression:
Required to select eligible patients. All three-dimensional radiographs will be taken with lip retractors.
An intra-oral digital impression of the maxilla will also be taken. Designated software will be used to merge dicoms files (three-dimensional radiograph) and the STL file (intra-oral digital impression) to fabricate a surgical guide.
Surgery:
All surgeries will be performed by two implant surgeons . Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (Ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia and oral disinfection the failing tooth is extracted as atraumatically as possible and without raising a flap. Following wound debridement, a cutting implant is installed in an optimal 3D position using a surgical guide. Socket grafting is performed with collagen-enriched deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a connective tissue graft (CTG) between 1 mm and 2 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is sutured with two or three single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Following provisional crown installation, an intra-oral radiograph is taken. This postoperative intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As this prospective study concerns a surgical intervention, patients and treating clinicians can not be masked.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 20 years old
- •Good oral hygiene defined as full-mouth plaque score ≤ 25%
- •Presence of one or more incisors, cuspids or premolars in the maxilla that need to be extracted for any reason with at least one neighboring tooth present
- •At least 3 mm bone available at the apical or palatal aspect of the alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability
- •Written informed consent.
排除标准
- •Pregnancy (will be explicitly asked)
- •Systemic diseases
- •Smoking; suppuration
- •> 1 mm gingival asymmetry between the failing teeth and contralateral teeth
- •Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph
- •Untreated periodontal disease; untreated caries lesions.
研究组 & 干预措施
Immediate implant placement
State of the art immediate implant placement with socket grafting and soft tissue augmentation.
干预措施: Immediate implant placement (Procedure)
结局指标
主要结局
Buccal bone thickness -1 (mm)
时间窗: moment of enrollment and 1-year
Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
次要结局
- Buccal bone thickness -3 and -5 (mm)(enrollment and 1-year)
- Marginal bone loss(1-, 5-year)
- Peri-implant health(1-, 5-year)
- Soft tissue changes(enrollment, 1-year , 5-year)
- Patient reported outcomes(one week after surgery)
- Pink Esthetic Score(enrollment, 1-year, 5-year)