NCT06570265尚未招募不适用
Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Assessment of collagen membrane's - efficacy and safety.
研究概览
简要总结
The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(among others):
- •Patients over 18 years old (both sex) with full legal capacity who understand the treatment and sign the informed consent and who are medically healthy, except treated condition.
排除标准
- •(among others):
- •Patients with dental diseases or conditions (except treated condition);
- •Patients with unsatisfactory oral hygiene;
- •Patients with alcohol, substance abuse, smoking habits, known allergy to collagen;
- •Patients with severe or chronic diseases or with systemic inflammation and all patients classified as unhealthy;
- •Pregnant or breast feeding women.
研究组 & 干预措施
Interventional arm
Experimental
干预措施: GBR membrane (Device)
结局指标
主要结局
Assessment of collagen membrane's - efficacy and safety.
时间窗: 6 months after intervention
Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.
次要结局
- Change in bone dimensions(Baseline, 6 and 12 months after intervention)
- Assessment of collagen membrane's - safety.(From the beginning till the end.)
- Complication rate(7 days and 6 months after intervention)
- VAS scale(On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.)
研究者
相似试验
Unknown
不适用
Clinical and Radiographic Outcomes of Distal Metatarsal Metaphyseal Osteotomy for Central Primary MetatarsalgiaMetatarsalgia BilateralNCT03639103University of Padova200
尚未招募
不适用
SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical StudyTreatment of Degenerative Diseases of the SpineNCT05828784SPS srl35
已完成
3 期
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)Crohn's DiseaseNCT00805766Tanabe Pharma Corporation39
已完成
不适用
A Registry for Participants With Chronic HypoparathyroidismHypoparathyroidismNCT01922440Takeda1,339
招募中
不适用
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing AdenomaAldosterone-producing AdenomaRadiofrequency AblationNCT05991856Third Affiliated Hospital, Sun Yat-Sen University45