Histological and Radiological Evaluation of Crosslinked vs Not Cross Linked Graft in Transcretal Sinus Elevation in Severely Resorbed Maxilla. A Prospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- histological analysis
研究概览
简要总结
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.
Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
详细描述
Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning).
Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope.
Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire.
Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning.
(Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
assessors analyzed blindly receiving anonymized bone samples and CBCT
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
- •Patient requiring vertical elevation of the maxillary sinus.
- •Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of < 3-4 mm.
- •Males and females between 30-80 years old
- •Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) <25%, Bleeding on Probing (BoP) <25%).
- •Patients that are willing to sign an informed consent and participate in a clinical Study.
- •Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
- •Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.
排除标准
- •Patient requiring vertical elevation of the maxillary sinus with native bone crest height > 5 mm
- •Patients who smoke over 5 cigarettes/day
- •Pregnancy (confirmed by verbal inquiry)
- •Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District
- •Patients taking bisphosphonates
- •Any sites where an implant already failed sites
- •Untreated Periodontitis
- •Dental sites with acute infections
- •Chronic inflammatory diseases of the oral cavity
- •Autoimmune diseases (cortisone intake)
- •Allergy declared to one or more medicaments to be used during treatment
- •Alcoholics patients and/or drug addicts
- •Patients with known collagen hypersensitivity.
- •Patients with sensitivity to porcine-derived materials.
- •History or malignant tumors of the maxillary sinus
- •History of local radiation therapy
结局指标
主要结局
histological analysis
时间窗: 6 months after graft insertion
samples were collected and histologically and immunohistologically analyzed
次要结局
- radiological analyis(12 months)
研究者
Luigi Canullo
prof
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo