Piezo-assisted Expansion of Narrow Ridges for Implant-supported Treatment of Intercalated Mono-edentulism: A Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- postoperative surgical width
研究概览
简要总结
the goal of the study was the evaluation of the clinical and histological performance of delayed inserted implants in augmented sites with a shaped solid graft inserted in an originally narrow alveolar edentulous ridge.
详细描述
Purpose To assess the efficacy of a two-stage piezo-assisted split crest technique and delayed implant insertion. Computed tomography, radiological, clinical, and histologic evaluation.
Research design Multicenter case-series
Sample size 20 patients People involved in the protocol At least 25 enrolled patients (5 per center) counting drop-outs
Inclusion criteria
- Patients with single mandibular or maxillary intercalated edentulism (1 implant) who require implant rehabilitation with conventional loading
- The edentulous site width should be comprised between 3 and 5mm for the first 3mm of height
- Presence of visible spongious bone in CBCT cross-sections
- The edentulous site must present at least 4mm wide band of keratinized tissue
- Plaque index < 20%, Bleeding index < 25%
- Medical condition of the enrolled patients should be within ASA 2 score
- Only no smokers, light smokers (< 10 per day) or electronic smokers will be accepted
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Patients with single mandibular or maxillary intercalated edentulism (1 implant) who require implant rehabilitation with conventional loading
- •The edentulous site width should be comprised between 3 and 5mm for the first 3mm of height
- •Presence of visible spongious bone in CBCT cross-sections
- •The edentulous site must present at least 4mm wide band of keratinized tissue
- •Plaque index < 20%, Bleeding index < 25%
- •Medical condition of the enrolled patients should be within ASA 2 score
- •Only no smokers, light smokers (< 10 per day) or electronic smokers will be accepted
排除标准
- •1. Head and neck RT in the previous 5 years
- •Previous or actual antiresorptive therapy
- •Chronic corticosteroid therapy
- •Active periodontal disease
- •Pregnancy or breastfeeding
- •Abuse of alcohol or drugs
- •Incapability of understanding the purposes of the study (e.g. mental deficit)
研究组 & 干预措施
narrow ridge
width comprised between 3 and 5 mm
干预措施: Alveolar Ridge Reconstruction (Procedure)
结局指标
主要结局
postoperative surgical width
时间窗: 5 months
radiologically measured alveolar expansion
次要结局
- new bone formation(5 months later than surgery)
研究者
prof. Roberto Di Lenarda
prof
University of Trieste