Histomorphometric and Immunohistochemical Evaluation of Bone Healing Around Implants Placed Using Piezosurgery Versus Conventional Drills: a Split Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Zone 1 (necrotic bone undergoing remodeling)
研究概览
简要总结
Purpose: The aim of this RCT was to evaluate and compare histomorphometric and immunohistochemical characteristics of peri-implant bone tissue after implant site preparation using piezoelectric tips versus conventional drills. Material and Methods: A split-mouth protocol was carried out on 6 patients with bilateral partial edentulism. A total of 12 alveolar ridges were randomized into two groups: 6 control sites (Group B) with conventional drills preparation (Drill-group) and 6 test sites (Group A) treated by piezoelectric implant inserts preparation (Piezo-group). At 28 days after surgery (T1), in both group, one study-fixtures with 0.5 mm of peri-implant bone tissue were explanted and processed for the histological, histomorphometrical and immunoistochemical analysis. For each sample Inflammatory infiltrates, necrotic bone (Zone 1), woven and newly formed bone (Zone 2), native bone (Zone 3), CD31 (cluster of differentiation 31) and SATB2 (special AT-rich sequence-binding protein necrotic bone undergoing remodeling) were evaluated.
详细描述
This was a pilot, parallel-group, doble-blinded, split-mouth, randomized clinical trial.
The study included six patients with bilateral partial edentulism, having in total 12 maxillary or mandibular edentulous alveolar ridges. All patients had been referred to the Unit of Oral and Maxillofacial Surgery, Alma Mater Studiorum, University of Bologna, Italy.
The alveolar ridges were randomized into two groups using a computer-generated method: Group A included six regions where implant sites were prepared by piezosurgery, and Group B six regions prepared by conventional drilling.
Surgical and prosthetic protocol In Group A, all implant sites were prepared with a piezoelectric device with IM1, IM2, IM2-3, or IM3 piezo-inserts according to the manufacturer's protocol (Piezosurgery, Mectron Medical Technology, Carasco, Italy). One or two implants were placed in each edentulous ridge along with an additional 3.3 x 8.5 mm implant, termed a "study fixture", in an adjacent area. In Group B, all implant sites were prepared with conventional drills according to the manufacturer's protocol (Premium, Sweden & Martina, Due Carrare, Padova, Italy); similarly to group A, one or two implants were placed in each edentulous ridge, and an additional 3.3 x 8.5 mm "study-fixture" was placed in the adjacent area.
After cover screw placement, a parallel periapical radiograph was taken and the flap was sutured with 4-0 Vicryl. After surgery, antibiotic therapy (1 g amoxicillin and clavulanic acid every 8 h for 4 days), analgesic therapy (nimesulid 200 mg/day for 2 days, continued if pain persisted), and antiseptic therapy (chlorhexidine 0.2% [w/v] three times daily), were prescribed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria: Inclusion Criteria:
- •bilateral edentulous sites in mandibles or maxillae that did not require bone regeneration prior to implant placement;
- •American Society of Anesthesiologists (ASA) status 1;
- •the capacity to understand and accept the conditions of the study;
- •continuing participation for at least 1 year of follow-up.
排除标准
- •Previous bone augmentation of the sites to be treated;
- •poor oral hygiene;
- •smoking > 10 cigarettes/day;
- •abuse of alcohol or drugs;
- •acute local or systemic infection;
- •uncontrolled diabetes or other metabolic disease;
- •severe hepatic or renal dysfunction;
- •HIV, HBV, or HCV infection;
- •chemotherapy or radiotherapy within the past 5 years;
- •current immunosuppressive therapy;
- •an autoimmune disorder;
- •bisphosphonate therapy
结局指标
主要结局
Zone 1 (necrotic bone undergoing remodeling)
时间窗: after 28 days of healing
Hystological sections were screened at high magnification (400×), and areas of necrotic bone lacking live osteocytes were automatically outlined with a pointer and photographed using a digital Peltier-cooled camera (Q-color 3; resolution 1,376 x 1,032 pixels; Olympus). Histological and histomorphometric analyses were performed on the central regions of each sample and Image J software (NIH, Bethesda, MD, USA) was used to determine the presence and type of inflammatory infiltrate, and to quantify morphometric parameters. Value expressed as percentage
次要结局
- CD31 (marker of vascular endothelium differentiation and neo-osteogenesis)(after 28 days of healing)
- Zone 2 (woven and newly formed bone)(after 28 days of healing)
- Zone 3 (native bone)(after 28 days of healing)
- SATB2(after 28 days of healing)
研究者
Alessandro Cucchi
Alessandro Cucchi
GBR Academy
