Could the Apico-coronal Position of the Implant Influence the Peri-implant Parameters in Mandibular Edentulous Type 2 Diabetics Rehabilitated With Implant-retained Overdentures? A Split-mouth RCT With 24-months Follow up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Change from baseline Peri-implant Probing Depth (PPD) at 24 months.
研究概览
简要总结
Diabetes Mellitus (DM) is a recognized factor affecting implant complication rates, including peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems interfere on the conditions of peri-implant tissues. However, the influence of the vertical implant position in type 2 diabetics (T2DM) is unclear. This split-mouth randomized controlled trial evaluated the impact of implants of machined-collar placed at crestal level or supracrestally in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.
详细描述
Considering the outcomes achieved with implants with machined-collar inserted supracrestally, it would be relevant to investigate whether this therapeutic strategy could be considered as a more effective approach in the rehabilitation with dental implants of individuals with type 2 DM, since these patients may be more disposed to peri-implant changes, both from the point of view of marginal bone remodeling as related to local variations in immunoinflammatory response. Thus, the propose of this split-mouth randomized controlled trial was to compare the impact of crestal level or supracrestally implant platform in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 59 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had T2DM, diagnosed by a physician, for at least the past 5 years. Such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin).
排除标准
- •Exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases [ulcers, gangrene, and amputation], neuropathy, and nephropathy) were also excluded.
研究组 & 干预措施
Implant placed at supra crestal level (SL)
Implants were placed at supra crestal level (SL)
干预措施: Dental Implant Placement and subsequent prosthetic reabilithation (Device)
Implant placed at crestal level (CL).
Implants were placed at crestal level (CL)
干预措施: Dental Implant Placement and subsequent prosthetic reabilithation (Device)
结局指标
主要结局
Change from baseline Peri-implant Probing Depth (PPD) at 24 months.
时间窗: (baseline) and at 6, 12 and 24 months
distance from the bottom of the peri-implant pocket (PPD) to the mucosal margin (MM) measured by a calibrated examiner in millimeter using a Periodontal probing
次要结局
- Clinical attachment level (CAL)((baseline) and at 6, 12 and 24 months)
- Markers on peri-implant crevicular fluid((baseline) and at 6, 12 and 24 months)
- Modified Plaque Index((baseline) and at 6, 12 and 24 months)
- Mucosal Margin (MM)((baseline) and at 6, 12 and 24 months)
- Modified Bleeding on Probing((baseline) and at 6, 12 and 24 months)
- Crest Height Bone Marginal Peri-implant((baseline) and at 6, 12 and 24 months)
研究者
Fernanda Vieira Ribeiro
Principal Investigator
Paulista University