A Randomized Controlled Trial on the Timing of Soft Tissue Grafting Following Immediate Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Buccal bone resorption (mm)
研究概览
简要总结
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this 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 availability for implant anchorage.
In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group).
Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability.
In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later.
In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above.
A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.
详细描述
Patients with a single failing tooth in the anterior maxilla will be included after a clinical examination and evaluation of a small-field low-dose CBCT. An intra-oral scan will be taken in order to make a surgical guide. A cutting implant with variable thread design (BLX, Straumann) will be installed using the surgical guide in order to sufficient primary implant stability.
Thereafter, the gap between the implant surface and buccal bone wall is filled with deproteinized bovine bone mineral (Bio-Oss, Gheistlich Pharma).
At this point, a closed envelope is opened and the patient gets assigned to either ISG or DSG group.
In the immediate soft tissue grafting group, a de-epithelialized free gingival graft was inserted in a buccal pouch to augment the buccal soft tissues. The graft was fixed with single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany).
In the delayed soft tissue grafting group, the same procedure was performed 3 months after implant placement.
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
- 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% (O'Leary et al. 1972)
- •Presence of an incisor, cuspid or premolar in the maxilla 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 as assessed on CBCT to ensure primary implant stability
- •Intact buccal bone wall at the time of extraction
- •Written informed consent
排除标准
- •Pregnancy
- •Systemic diseases
- •Suppuration
- •> 1 mm gingival asymmetry between the failing and contralateral tooth
- •Untreated periodontal disease; untreated caries lesions
结局指标
主要结局
Buccal bone resorption (mm)
时间窗: 1-, 5-year
Changes in buccal bone dimension as measured on superimposed CBCT slides
次要结局
- Mucosal Scarring Index(1-year)
- Probing depth (mm)(1-,5-year)
- Changes in midfacial soft tissue level (mm)(1-, 5-year)
- Plaque (%)(1-,5-year)
- Changes in buccal soft tissue profile (mm)(1-, 5-year)
- Pink Esthetic Score(1-year)
- Marginal bone level changes (mm)(1-,5-year)
- Bleeding on probing (%)(1-,5-year)