Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pink and white esthetic scores (PES/WES)
研究概览
简要总结
The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.
详细描述
Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old and able to understand an informed consent
- •Adequate oral hygiene to allow for implant therapy consistent with standards of care.
- •Missing a single tooth in the maxillary anterior region
- •Presence of adjacent natural teeth
排除标准
- •Poor oral hygiene
- •Severe parafunctional habits, for example, bruxing and clenching
- •Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
- •Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
- •Pregnant or expecting to be pregnant
- •History of drug and alcohol abuse
- •History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
- •Radiotherapy in the head and neck area,
- •On certain medications like bisphosphonates or steroids currently or within the past three months
- •Absence of adjacent teeth
- •Unwillingness to return for the follow-up examination
- •Smokers (more than 20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery
研究组 & 干预措施
Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
干预措施: Type 1 implant placement (Procedure)
Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
干预措施: Type 3 implant placement (Procedure)
结局指标
主要结局
Pink and white esthetic scores (PES/WES)
时间窗: Up to 10 years after baseline
Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Radiographic bone volume
时间窗: Up to 10 years after baseline
Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
次要结局
- Implant survival(Up to 10 years after baseline)
- Modified bleeding index(Up to 10 years after baseline)
- Buccal marginal recession(Up to 10 years after baseline)
- Papilla volume(Up to 10 years after baseline)
- Probing depth(Up to 10 years after baseline)
- Modified plaque index(Up to 10 years after baseline)
- Width of keratinized gingiva(Up to 10 years after baseline)
- Visual analogue scale (VAS)(Up to 10 years after baseline)
- Oral health impact profile shortened version (OHIP-I)(Up to 10 years after baseline)
研究者
Xin Liu
post graduate
Sun Yat-sen University