Flapless Immediate Implants in Type 1 Alveoli: Soft Tissue Alterations Following a Trimodal Approach With or Without Modifying Osseous and Mucosal Compartments (TAOM vs TA) in the Aesthetic Zone: A Comparative Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Distance from measuring points on the reference stent to gingival zenith of the implant restoration in tenths of a milimetre by means of a precision digital calliper.
研究概览
简要总结
The aim was to compare two protocols for immediate implants with fixed provisional restoration, no grafting (trimodal approach=TA) versus grafting both osseous gap and peri-implant mucosa (trimodal approach with modification of the osseous and mucosal compartments =TAOM) by measuring the soft tissue changes overtime. The periodontal phenotype was registered, to investigate a relationship between its thickness and the clinical outcomes.
详细描述
The study protocol was approved by the CEIm Quiron Salud Catalunya institutional research ethic committee (Approval code:2022/102_MAX:CEX). This prospective clinical study includes patients who were enrolled and treated in two private practices (GC and JGF). All eligible patients were consecutively selected for two study groups receiving immediately placed flapless implants and the provisional restoration. Patients were informed about the characteristics of the study and signed their informed consent before the study began.
Patient population
Patients in need of single implant supported restorations in the anterior maxilla (canines, lateral and central incisors) were selected for this study. The indications for tooth extractions were cavities, endodontic complications (e.g., root fracture), internal resorption and prosthetic reasons. The patients had to fulfil the following inclusion and exclusion criteria:
Inclusion criteria:
- ≥18 years of age
- Need for tooth extraction in the anterior maxilla (13-23) due to cavities, internal resorption, fractures, restorative problems, endodontic complications and prosthetic reasons.
- The failing tooth has adjacent and opposing natural teeth
- Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%);
- Absence of active and uncontrolled periodontal disease
- Sufficient mesial-distal and interocclusal space for implant placement and definitive restoration
- Sufficient interocclusal space to design a non-occluding provisional restoration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Need for tooth extraction in the anterior maxilla (13-23) due to cavities, internal resorption, fractures, restorative problems, endodontic complications and prosthetic reasons.
- •The failing tooth has adjacent and opposing natural teeth
- •Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%);
- •Absence of active and uncontrolled periodontal disease
- •Sufficient mesial-distal and interocclusal space for implant placement and definitive restoration
- •Sufficient interocclusal space to design a non-occluding provisional restoration
排除标准
- •Systemic metabolic or osseous disease that could compromise peri-implant tissue healing.
- •Acute infection in the treatment area
- •Absence of one or both adjacent teeth
- •Non-integrity of the buccal bone wall (dehiscence or fenestration) observed during surgery, or when tooth extraction has altered the integrity of the osseous and gingival architecture
结局指标
主要结局
Distance from measuring points on the reference stent to gingival zenith of the implant restoration in tenths of a milimetre by means of a precision digital calliper.
时间窗: 12 months
Vertical midfacial soft tissue change from baseline (before tooth extraction) to 12 months following implant placement.
次要结局
- Distance from measuring points on the reference stent to mesial and distal papillae of the implant restoration in tenths of a milimetres by means of a precision digital calliper.(12 months)
- Periodontal thickness at 5mm apical to the gingival margin in tenths of a milimetre.(Baseline)