Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amount of peri-apical bone healing
研究概览
简要总结
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.
详细描述
This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (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 (Outcomes Assessor)
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
- •Provision of Informed Consent
- •Patients from 18 years old
- •Patients in need of an EMS
- •EMS is the only option to cure the periapical lesion
- •A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT
排除标准
- •Unlikely to be able to comply with the study procedures, as judged by the investigator
- •Orthograde endodontic (re)treatment is indicated
- •Known or suspected current malignancy
- •History of chemotherapy within 5 years prior to study
- •History of radiation in the head and neck region
- •History of other metabolic bone diseases
- •History of bleeding disorders
- •HIV disease
- •Hepatitis B or C
- •Systemic disease (osteoporosis, diabetes...)
研究组 & 干预措施
With L-PRF Block
干预措施: Endodontic Microsurgery (Procedure)
No L-PRF Block
干预措施: Endodontic Microsurgery (Procedure)
结局指标
主要结局
Amount of peri-apical bone healing
时间窗: 1 year
Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).
次要结局
- Patient related outcomes(7 days)
- Bone or scar tissue healing(1 year)
- Success & survival rate(1 year)
- Dentinal defects(1 year)