Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Crestal bone level changes.
研究概览
简要总结
The objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study.
详细描述
The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible. The primary outcome is the change in the interproximal crestal bone level.
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University. Adult patients (males and females) in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study. Following initial screening procedures, each patient underwent a site-specific intraoral and radiographic examination (Cone Beam Computed Tomography analysis and periapical radiographs) in order to make sure that the inclusion criteria were satisfied. Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study. The day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used:
The first group (group 1) consisted of patients receiving Straumann Standard Plus (SP) implants of 4.1 mm in diameter and length of 10 mm.
The second group (group 2) included patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.
Participants were blinded as to the assignment in the first or second group. The implant placement procedures were planned based on clinical and radiographic evaluation.
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 day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software (Keamk) each site was randomly assigned to one of the two groups based on the implant system used.
Participants were blinded as to the assignment in the first or second 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
- 是
入选标准
- •Patients over the age of 18, requiring placement of at least two adjacent implants in the posterior maxilla or mandible (premolar-molar area)
- •Patients willing to sign the consent form and respect the follow-up period of the study
- •Non-smokers or light smokers (less than 10 cig/day)
- •No bone augmentation procedures before or during implant placement in the area of interest
- •Healthy soft tissue conditions (full mouth plaque scores < 20% and full mouth bleeding index < 20%)
- •Minimum height of 2 mm of keratinized tissue
- •Minimum of 6 mm in bone width and 10 mm in bone height
- •Minimal distance of 2 mm between predicted implant tip and inferior alveolar nerve
- •Healed sockets (at least 4 months post-extraction)
排除标准
- •Patients not satisfying the inclusion criteria
- •Patients with any local or systemic disease
- •Patients taking any kind of medication that interferes with bone metabolism
- •Pregnant or breast-feeding women
- •Patients with parafunctional disorders
- •Patients with poor oral hygiene
- •Heavy smokers (>10 cig/day)
结局指标
主要结局
Crestal bone level changes.
时间窗: Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.
Peri-implant CBL changes were assessed using periapical radiographs. Radiographs were taken according to the long cone, paralleling technique, using a positioner (XCP Rinn holders, Dentsply Friadent Schweiz, Nidau, Switzerland) parallel to the implant axis and perpendicular to the cone of rays. An individualized radiographic mount (foam and acrylic) was used for each patient to standardize the periapical radiographs. This technique allows the repositioning of the image plate in future radiologic examinations. For the digital process, an image measuring program, Image J (Wayne Rasband, National Institutes of Health) was used.
次要结局
- Initial soft tissue thickness.(Vertical soft tissue thickness was measured immediately during the implant placement.)
- Primary and secondary implant stability.(Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.)
研究者
Sandrine Abi Rached
Principal Investigator
Saint-Joseph University