Platform Switching vs Regular Platform Implants. One Year Results From a RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Implant Survival
研究概览
简要总结
The present study tested the hypothesis that Platform Switching (PS) and Regular Platform (RP) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.
详细描述
This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (PS group), or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy bone and the healing abutment was connected at the same time. Both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months. Statistical analyses were conducted using computational program SAS (version 9.2), with 1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •need for single bilateral fixed implant-supported prosthesis in molar area
- •stable interocclusal contacts
- •≥18 years of age
- •provided written informed consent
- •residual bone height ≥10 mm
- •residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally
排除标准
- •general contraindications to implant surgery
- •lack of occluding dentition in the area intended for immediate loading
- •periodontitis
- •immunosuppression
- •previous history of irradiation of the head and neck area
- •uncontrolled diabetes
- •heavy smoker (>10 cigarettes/day)
- •poor oral hygiene
- •current or past treatment with bisphosphonates
- •substance abuse
- •psychiatric disorder
- •inability to complete follow-up ≥1 year
- •lactation
- •implant insertion torque less than 35 Ncm
研究组 & 干预措施
Implant outcome
This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area.
A total of 18 consecutive patients were enrolled. In each eligible patient, the right molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP)
干预措施: Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden) (Device)
Implant outome
This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area.
A total of 18 consecutive patients were enrolled. In each eligible patient, the left molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP)
干预措施: Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden) (Device)
结局指标
主要结局
Implant Survival
时间窗: Up to 12 months
implant survival: The removal of implants was dictated by instability, progressive marginal bone loss, infection or implant fracture.
次要结局
- Change in marginal bone levels(Baseline, 12 months)
研究者
Silvio Mario Meloni
DDS, Phd, MS
Università degli Studi di Sassari