Influence of Neck Design on Peri-implant Hard and Soft Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Buccal bone width (BBW)
研究概览
简要总结
The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question[s] it aims to answer are:
- do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?
- do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?
Participants that present an unrepairable tooth on the anterior upper maxilla will be asked to take a CBCT scan in order to verify the presence of the buccal bone. Once this is verified the patients will enter in the study and the day of the surgery they will be assigned to either control or test group.
- Control group: C1 round-neck implant
- Test groups: V3 triangular-implant neck
Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.
详细描述
Immediate implant placement is considered to be a technique-sensitive protocol with a variety of potential risks. The interface area between the neck of the implant and the abutment is critical; it can affect the treatment outcome, particularly mar-ginal bone loss (MBL) and soft tissue behavior. Traditionally, the implant neck is circu-lar in shape; however, a new triangular neck design has recently been introduced on the market, though advanced indications of this innovative design are still lacking.
The objective of this randomized clinical trial was to compare the clinical and radiographic outcomes obtained after immediate placement of implants and temporization of two different neck geometries: a traditional round neck (RN) and an innovative neck with a triangular shape (TN).
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
- None
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
- •healthy non-smokers or light smokers (< 10 cigarettes/day)
- •adults (> 18 years of age),
- •need for single tooth extraction of a maxillary incisor, canine or premolar
- •adequate oral hygiene
- •ability to follow instructions and attend the required appointments
- •presence of a length of at least 3 mm of buccal bone measuring ≥ 0.5 mm in thickness, apical to the extraction socket
- •stable and intact socket walls
排除标准
- •patients with acute infections in the area of interest
- •individuals with large occlusal discrepancies and/or occlusal overload para-functions
- •smokers of more than 10 cigarettes/day
- •patients with any medical condition or medication contraindicating dental implant treatment
结局指标
主要结局
Buccal bone width (BBW)
时间窗: 4 months
buccal bone width was measured by CBCT (iCAT®, Imaging Science International, LLC, Hatfield, PA, USA) at four points: at the implant neck, and at 1 mm, 2 mm and 3 mm above the implant neck.
Marginal bone loss (MBL)
时间窗: 3 years
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Soft tissue thickness (STT)
时间窗: 3 years
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
次要结局
- Insertion torque (IT):(day 1)
- Bleeding on probing (BOP):(3 year)
- ISQ (implant stability quotient):(day 1)
- Probing pocket depth (PPD):(3 year)
- Crestal width (CW)(3 year)
- Pink esthetic score (PES):(3 year)
研究者
Jordi caballé
Dr, MSc, PhD
Universitat Internacional de Catalunya