Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Radiographic bone volume
研究概览
简要总结
The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.
详细描述
The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were as follows:
- •18 to 70-year-old;
- •Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
- •Single maxillary anterior teeth (canine to canine);
- •Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；
- •Presence of adjacent nature tooth;
- •Good compliance;
- •No palatal vertical bone loss;
- •Good oral hygiene.
排除标准
- •are as follow:
- •Uncontrolled periodontal or systemic disease;
- •General psychiatric contraindications;
- •More than 20 cigarettes per day;
- •History of head and neck radiotherapy；
- •Pregnant or expecting to be pregnant;
- •Patients with local or generalized healing limitations;
- •Bruxism or other destructive parafunctional habits;
- •Drug abuse or alcohol abuse.
结局指标
主要结局
Radiographic bone volume
时间窗: Up to 10 years after baseline
Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
次要结局
- Visual analogue scale (VAS)(Up to 10 years after baseline)
- Papilla volume(Up to 10 years after baseline)
- Change of Pink and white esthetic scores (PES/WES)(Change from baseline up to 10 years after implantation)
- Buccal marginal recession(Up to 10 years after baseline)
- Oral health impact profile shortened version (OHIP-I)(Up to 10 years after baseline)
- Width of keratinized gingiva(Up to 10 years after baseline)
- Probing depth(Up to 10 years after baseline)
- Modified plaque index(Up to 10 years after baseline)
- Implant survival(Up to 10 years after baseline)
- Modified bleeding index(Up to 10 years after baseline)
研究者
Baoxin Huang
Principal Investigator
Sun Yat-sen University