Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- • Bone Volume total (%BV)
研究概览
简要总结
The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.
Synergoss is a granulated bone graft intended for use in dental applications. It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on the ceramic granule surface.
The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a synthetic dental graft coated with collagen. For this observational study, we will enroll patients that already received a surgical intervention for sinus augmentation/ socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants, about 24 weeks after the first surgery for the implant of SYNERGOSS.
The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File.
The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File.
The study design is a
- National
- Monocentric
- Prospective: the participants are identified and then followed forward in time.
- Observational: participants that have recently received the grafting with SYNERGIES as part of normal and foreseen clinical procedures are enrolled in the study when they receive surgery for titanium implant placement and observed over time, with no substantial intervention other than the foreseen clinical treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID
- •Capable of giving a valid informed consent
- •ASA 1, ASA 2
- •agrees to return for follow-up visits up to 2 years
排除标准
- •• Uncontrolled Diabetes
- •Patients with psychiatric diseases
- •Neoplasic, immunodepressive, renal or liver major illnesses
- •Local radiotherapy
- •Major bruxism or major differences in the maxilla or mandubilar area
- •Drug or alcohol abuse
- •Major bone metabolism disorders
- •Heavy smokers (more than 10/day)
- •bisphosphonate treatment of major ostheoporosys or bone neoplasia
- •Pregnant women
- •Sinus illnesses
- •Contraindications to implant supported prostheses
- •Patients ASA 3,ASA 4, ASA5
- •Surgical intervention contraindications
结局指标
主要结局
• Bone Volume total (%BV)
时间窗: 4-6 months
The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of total bone volume as compared to the specimen volume
• graft Volume (%graft)
时间窗: 4-6 months
The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of residual, non absorbed graft volume as compared to the specimen volume
• device radiologic density (in a qualitative scale ranging from 1 to 4)
时间窗: 4-6 months
the radiological density is visually evaluated by the investigator
• vital bone (%VB).
时间窗: 4-6 months
The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of vital, new formed bone volume as compared to the specimen volume
次要结局
未报告次要终点