Alveolar Ridge Preservation With Immediate or Late Implant Placement: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Need for soft tissue augmentation (true or false) as judged by a panel of clinicians
研究概览
简要总结
Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter randomized controlled trial (RCT). Prior to surgery, a small-field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement').
For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction.
In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed.
In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface.
A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later.
Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site.
Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.
详细描述
Patient selection Patients in need of a single implant in the premaxilla (15-25) will be included in this multicenter RCT following screening and after having received written consent.
Sample size calculation A sample size calculation using the Pearson Chi-square test was performed in SAS Power and Sample Size based on a comparison of the proportion on the need for soft tissue augmentation at 5 months following alveolar ridge preservation (ARP) between the control group (ARP + delayed implant placement 'DIP') and test group (ARP + immediate implant placement 'IIP'). The calculation was based on finding a 30% difference between these groups. With alpha set at 0.05 and a power of 0.80, the sample size calculation indicated 28 patients to be included per group. To compensate for drop-outs, 30 patients would be treated with ARP+DIP and 30 would be treated with ARP+IIP.
Clinicians and centers, randomization, allocation concealment and blinding Six experienced clinicians will treat at least 10 patients each. Five clinicians are staff members of the Department of Periodontology and Oral Implantology at UGent - UZ Gent, who also work part-time in different private practices. The final clinician is a professor at the Saint-Luc University Hospital (UCL). The digital workflow, the implant placement protocol, the application of a connective tissue graft (CTG) at 6 months following ARP and the restorative protocol will be thoroughly discussed among the 6 clinicians in a training session before the start of the trial.
During the training session each clinician will receive 5 sealed envelopes internally coded as 'Delayed implant placement' and another 5 as 'immediate implant placement'. Just prior to surgery, a sealed envelope will be randomly selected and opened to reveal the treatment to be conducted. The measuring investigator will not be involved in the treatment of any of the patients and will be blinded to allow unbiased registrations.
Pre-operative digital planning for fabrication of surgical guide A digital workflow will be adopted for every patient for fabrication of a surgical guide prior to tooth extraction. This requires 3D digital implant planning in designated software on the basis of a pre-op low-dose small-field Cone-Beam CT and intra-oral scan. Note that surgical guides for patients in the ARP+DIP group will also be fabricated following patient selection, even though they are only to be used 4 months later.
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
As this RCT concerns a surgical intervention, patients and treating clinicians can not be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years old
- •good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- •presence of a single-rooted tooth in the anterior maxilla (15-25) that needs 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 alveolus to ensure primary implant stability
- •intact or nearly intact buccal bone wall at the time of extraction (max 3 mm bone missing = max 6 mm distance from free gingival margin to buccal bone crest)
排除标准
- •systemic diseases
- •untreated periodontal disease
- •untreated caries lesions
结局指标
主要结局
Need for soft tissue augmentation (true or false) as judged by a panel of clinicians
时间窗: 6 months
The need for soft tissue augmentation is assessed by the 5 clinicians who have not been clinically involved. The treating clinician is excluded since he/she cannot be blinded for the treatment group. The need for soft tissue augmentation is assessed on the basis of clinical pictures, a CBCT image and STL file.
次要结局
- Change in buccal bone thickness(pre-op, 1 year, 5 year)
- Changes in radiographic outcomes(implant placement, 1 year, 3 years, 5 years)
- Change in width of the alveolar process(pre-op, 1 year, 5 year)
- Implant survival(6 months, 9 months, 1 year, 3 years, 5 years)
- Keratinized mucosa width(pre-op, 1 year, 3 years, 5 years)
- Bleeding on probing(pre-op, 1 year, 3 years, 5 years)
- Plaque(pre-op, 1 year, 3 years, 5 years)
- Aesthetic outcome as assessed by care providers(pre-op, 1 year, 3 years, 5 years)
- Aesthetic outcome as assessed by patients(pre-op, 1 year, 3 years, 5 years)
- Clinician-reported outcome measures(per-op)
- Changes in buccal soft tissue profile(pre-op, 6 months, 1 year, 3 years, 5 years)
- Vertical change in midfacial soft tissue level(pre-op, 6 months, 1 year, 3 years, 5 years)
- Complication(Up to 5 years)
- Change in height of the alveolar process(pre-op, 1 year, 5 year)
- Probing pocket depth(pre-op, 1 year, 3 years, 5 years)