NCT02864862已完成4 期
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in Ridge Dimension
研究概览
简要总结
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are in need of a tooth extraction at the maxillary premolar, canine and incisor region, and subsequent single implant placement.
- •The reasons for extraction will include poor endodontic prognosis and/or unrestorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, root perforation, root resorption with or without radiographic periapical lesion up to 3 mm in diameter). patients who are systemically healthy or with controlled common systemic conditions (controlled hypertension, controlled diabetes HbA1c up to 7 %).
- •adjacent teeth have to be present and the eligible tooth has esthetically acceptable buccal gingival margin position prior to surgery, compared to neighboring teeth and contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).
- •level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
- •Location of buccal alveolar crest has to be generally within 4 mm from the free gingival margin, verified after the extraction, before randomization; and fenestration, if present, up to 3mm in diameter at the apical part of the root and affecting less than 30% of the buccal socket wall.
排除标准
- •currently smoke exceeding 10 cigarettes/ day
- •severe parafunctional habits, malocclusion or intent of orthodontic therapy in the future and are pregnant.
- •teeth in the surgical site will be excluded if there is advanced periodontal disease or periapical lesion causing significant bony defects that are beyond the criteria mentioned at Section 3.
- •allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin, polymixin B and Vancomycin) will not be included in the immediate implant combined with ADM group.
结局指标
主要结局
Change in Ridge Dimension
时间窗: baseline, 12 months after surgery
Change in ridge dimension is calculated as the value at 12 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 12 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.
次要结局
- Change in Alveolar Bone Level (Crestal)(baseline, 6 months after surgery)
- Change in Gingival Level(baseline, 6 months after surgery)
- Change in Gingival Thickness(baseline, 6 months after surgery)
- Change in Bone Dimension(baseline, 6 months after surgery)
- Change in Width of Keratinized Gingiva(baseline, 6 months after surgery)
- Change in Alveolar Bone Level (Marginal)(baseline, 6 months after surgery)
研究者
Chun-Teh Lee
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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