A Multicenter Randomized Controlled Study Comparing Connective Tissue Graft with Collagen Matrix to Re-establish Convexity At the Buccal Aspect of Single Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in buccal soft tissue profile (BSP)
研究概览
简要总结
Patients in need of a single implant in the premaxilla and presenting with a horizontal buccal soft tissue defect at the single tooth gap will be invited to participate in a multicenter RCT. Prior to surgery, a small-field low-dose CBCT is taken since a buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap is required to ensure complete embedding of an implant by bone. 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 'test group' and 5 with 'control group').
For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated. In the control group, a single implant is placed following flap elevation and surgical guide installation. Then, a CTG from the palate is positioned under the buccal mucosa to thicken the tissues. A provisional restoration is placed at the day of surgery, which is replaced by a permanent one 3m later. Patients in the test group are treated in the same way, yet a CM (Fibro-Gide®) is used instead of a CTG.
Changes in the buccal soft tissue profile are registered over time by superimposing intra-oral scans in SMOP® software.
Secondary outcomes included clinical, aesthetic and patient-reported outcomes.
详细描述
Patients will be included in a multicenter RCT following screening and after having received written consent.
A sample size calculation using the Satterthwaite t-test was performed in SAS Power and Sample Size based on a comparison of mean change in BSP (primary outcome variable) from baseline to 1 year between the control group and test group. The calculation was based on finding a mean difference of at least 0.5 mm between these groups with a standard deviation of 0.5 mm for CTG and 0.7 mm for CM (as adopted from Zeltner et al. 2017). With alpha set at 0.05 and a power of 0.80, the sample size calculation indicated 25 patients to be included per group. To compensate for drop-outs, 30 patients would be treated with CTG and 30 would be treated with CM.
Clinicians and centers, randomization, allocation concealment and blinding Six experienced clinicians will treat 10 patients each. All 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 digital workflow, the implant placement protocol, the application of CTG and CM 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 'CTG' and another 5 as 'CM'. 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 A full digital workflow will be adopted for every patient. This implies the fabrication of a stereolythographic surgical guide on the basis of a 3D digital implant planning in designated software (NobelClinician, Nobel Biocare, Zürich, Switserland). A low-dose small-field Cone-Beam CT and intra-oral scan are required for this purpose. The same software will also be used to design a provisional acrylic crown, which will be adapted chairside immediately following surgery (Tempshell, Nobel Biocare, Zürich, Switserland).
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
It concerns a surgical intervention. Hence, the treating surgeon and patient cannot be masked. The investigators and outcome assessors are 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%
- •presence of a single tooth gap in the anterior maxilla (15-25) with both neighboring teeth present
- •failing tooth at least 3 months earlier removed
- •class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height)
- •buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone.
排除标准
- •systemic diseases
- •(history of) periodontal disease;
- •untreated caries lesions
- •need for horizontal bone augmentation at the time of implant placement
结局指标
主要结局
Changes in buccal soft tissue profile (BSP)
时间窗: Pre-op, 3 months, 1 year, 2 years
Volumetric analysis with designated software on the basis of intra-oral scans at fixed time points (absolute changes in mm, relative changes in %)
次要结局
- Changes in radiographic outcomes(3 months, 1 year, 2 years)
- Incremental cost-effectiveness ratio(baseline - 2 years)
- Changes in Bleeding on probing(3 months, 1 year, 2 years)
- Changes in Plaque Index(3 months, 1 year, 2 years)
- Aesthetic outcome as assessed by care providers(2 years)
- Surgery time(At Surgery)
- Changes in Probing pocket depth(3 months, 1 year, 2 years)
- Primary stability(At Surgery)
- Patient-reported outcome measures(2 years)