Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of adjunctive bone and soft tissue augmentation procedures need.
研究概览
简要总结
After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:
- Immediate Implant Placement and Immediate Provisionalization
- Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
- Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.
详细描述
The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:
- patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
- cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
- volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
- clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
- Implant Success and Survival at 1, 3 and 5 years after final prosthesis.
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
- 是
入选标准
- •single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
- •smoking no more than 10 cigarettes/day,
- •periodontal health (BoP < 10%) and good plaque control (< 20%)
- •absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
- •extraction sites with less than 30% loss of one or more walls
- •adequate quantity and quality of native bone to achieve primary stability
排除标准
- •growing patients
- •patients with autoimmune disease, uncontrolled diabetes or immunocompromised
- •history of head and neck radiation for cancer treatment,
- •pregnancy
结局指标
主要结局
Rate of adjunctive bone and soft tissue augmentation procedures need.
时间窗: during implant placement
Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness \< 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.
次要结局
- Peri-Implant Health(1, 3, 5 years post loading)
研究者
Marco Clementini
Research Fellow
Centro Specialistico Odontoiatrico, Rome