Effect of Peri-implant Gap Grafting and Immediate Provisionalization With Customized Healing Abutments on the Stability of Peri-implant Soft Tissues - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Peri-implant marginal bone level- Radiographic Measurements
研究概览
简要总结
Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
详细描述
Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.
The primary objective is:
- The implant success
The Secondary objectives are:
- The Changes in mid-facial mucosal recession
- The changes in papilla height
- The changes in soft tissue ridge width
- The aesthetic evaluation
- The implant stability
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 (Participant)
盲法说明
The participants ant the biostatician will be blinded on the assignment group
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
- •The patient is ≥ 18 years old
- •Extraction of single rooted tooth with healthy adjacent teeth (PD<5mm, no BOP)
- •Patient must be able to understand the purpose of the study and to sign the consent form
排除标准
- •Smoking status of more than 10 cigarettes/day
- •History of uncontrolled metabolic disorders (e.g. diabetes mellitus)
- •History of malignancy, radiotherapy, or chemotherapy
- •Pregnant or breast feeding
- •History of immunodeficiences
- •existence of metabolic bone disease or disease affecting bone healing
- •untreated or active periodontitis (BOP and PD>5mm)
- •absence or defects of the buccal bone plate
结局指标
主要结局
Peri-implant marginal bone level- Radiographic Measurements
时间窗: 3 years of follow up
Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.
Implant success
时间窗: 3 years of follow up
Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection
次要结局
- Changes in mid-facial mucosal recession(3 years of follow up)
- Aesthetic evaluation (PES)(3 years of follow up)
- Changes in papilla height(3 years of follow up)
- Changes in soft tissue ridge width - Volumetric measurements(3 years of follow up)
- Implant stability (ISQ)(3 years of follow up)
研究者
Alexandre Perez
Dr
University of Geneva, Switzerland