Influence of Soft Tissue Thickness on the Marginal Bone Level Around Implants in Esthetic Zone: 1 Year Randomized Control Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Ultrasound examination
研究概览
简要总结
Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant.
详细描述
Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant.
Purpose:
The aim of the study was to determine the effect of soft tissues in the implant area on the marginal bone level loss in the implant area and to define of the critical gingival thickness to minimize marginal bone level (MBL) loss.
Materials and methods
75 bone level implants (Conelog® Camlog, Switzerland) were inserted in the aesthetic area. Thickening of soft tissues was performed both before and after implantation (group II and III), CTG and XCM were used (subgroup a and b). 12 months after the loading with final restoration, the thickness of soft tissues in the implant area was examined with ultrasonography (USG) device (Pirop®, Echoson, Poland), and each implant was subjected to Radiovisiography (RVG) RVG examination, where MBL loss was determined.
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)
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
- •To qualify for the study, the patients had to be >18 years and have missing teeth in the esthetic zone. Additional inclusion criteria were as follows:
- •missing single or double teeth in the anterior area of their upper or lower jaw with a proper inter arch relationship (incisors, canines and first premolar) with a ridge width (bucco-lingual) greater than 5 mm at its narrowest point and a minimum keratinized gingiva height of 2 mm buccally.
- •No previous soft tissue augmentation procedure at experimental site
排除标准
- •The criteria that disqualified patients from the study were previous grafting procedures in the area of interest and systemic or local diseases that could compromise healing or osteointegration. Smokers and patients with bruxism were also excluded from the study. Additional exclusion criteria were as follows:
- •implants placed with an insertion torque of 35 Ncm or less;
- •irradiation in the head and neck area;
- •untreated periodontitis;
- •poor oral hygiene (plaque score Approximal Plaque Index (API) 20%, bleeding score 10%) and
- •poor motivation;
- •fresh post extraction sockets
结局指标
主要结局
Ultrasound examination
时间窗: 12 months
ultrasound USG examination of tissue hickness
Radiological examination
时间窗: 12 monhs
RVG examination of marginal bone level change
次要结局
未报告次要终点
研究者
Jakub Hadzik
DDS, PhD, Principal Investigator
Akademicka Poliklinika Stomatologiczna