NCT04851847Unknown不适用
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
Collagen Matrix1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2021年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- The change of CAL at 12 weeks after surgery
研究概览
简要总结
This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years, male or female;
- •patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;
- •Only solitary lesion site requires surgical treatment and must meet the following criteria:
- •The baseline PD≥7 mm ;
- •After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected;
- •The wideness of the keratinized gingiva≥2 mm;
- •Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;
排除标准
- •The test tooth has open surgical debridement history within the most recent one years;
- •Known allergy to collagen of animal origin;
- •Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;
结局指标
主要结局
The change of CAL at 12 weeks after surgery
时间窗: 12 weeks
Assessment of clinical attachment level
The change of PD at 24 weeks after surgery
时间窗: 24 weeks
Assessment of Probing Depth
The change of CAL at 24 weeks after surgery
时间窗: 24 weeks
Assessment of clinical attachment level
The change of PD at 12 weeks after surgery
时间窗: 12 weeks
Assessment of Probing Depth
次要结局
- The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.(12 weeks)
- The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression FracturesVertebral Compression FractureCompression FractureVertebral CompressionNCT04835428AgNovos Healthcare, LLC408
已完成
4 期
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver DysfunctionFatigueNCT02415777Daewoong Pharmaceutical Co. LTD.168
已完成
不适用
A Clinical Study to Evaluate the Efficacy of an Anti-Aging SerumFine LinesWrinklePhotoagingNCT05271136Revision Skincare26
已完成
4 期
Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML PatientsThrombocytopeniaNCT02267993Institute of Hematology & Blood Diseases Hospital, China58
尚未招募
不适用
Patient Education in the Clinical Management of PessaryPelvic Organ ProlapseNCT06432218Peking Union Medical College Hospital280