Submerged vs. Nonsubmerged Single Laser-microgrooved Implants. Clinical and Radiographic Results at 3-years of RCT With Split Mouth Design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- radiographic marginal bone loss
研究概览
简要总结
Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.
详细描述
Materials and methods
20 submerged/two-stage implants and 20 nonsubmerged/one stage implants were placed randomly with a split mouth design, in 20 partially edentulous patients. Radiographic and clinical examinations were carried out at the implant placement (Baseline, BSL), at the delivery of prosthetic restorations (T0), and at each year of the follow-up period (T1, T2, T3). Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and gingival recession (REC) were recorded. Radiographic marginal bone levels (MBL) were assessed at the mesial (MI) and distal (DI) aspect of implant sites. In addition, the influence of keratinized tissue thickness (KTT) on MBL was investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla.
排除标准
- •Exclusion criteria were: implants placed into regenerated bone, lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) ≥25%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.
研究组 & 干预措施
dental implants
microgrooved dental implants submerged
干预措施: Microgrooved dental implants (Device)
dentale implants
microgrooved dental implants nonsubmerged
干预措施: Microgrooved dental implants (Device)
结局指标
主要结局
radiographic marginal bone loss
时间窗: 3 years
次要结局
未报告次要终点
研究者
Renzo Guarnieri
professor
University of Roma La Sapienza