Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects
Injectable Platelet-Rich Fibrin (i-PRF) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
研究概览
地位
详细说明
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated.
Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma.
Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Amir R Elngar, B.D.S
- 电话号码：00201004634587
- 邮箱：amirreda059@gmail.com
学习地点
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Cairo、埃及、12511
- 招聘中
- October 6 University
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接触：
- Amir R Elngar, B.D.S
- 电话号码：00201004634587
- 邮箱：amirreda059@gmail.com
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副研究员：
- Reham L Aggour, MD
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副研究员：
- Amany A Alaraby, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.
- Diagnosis of 'periodontitis' stage III (grades B or C).
- Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
- Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.
Exclusion Criteria:
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
- Pregnant and lactating women
- Current use of any form of tobacco.
- Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
- Degree 2 or 3 mobility of the involved sites.6.
- Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group 1 (control group)
Patients will receive minimally invasive non-Surgical technique (MINST) alone
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Patients will receive minimally invasive non-Surgical technique (MINST) alone
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实验性的：Group 2 (Test group)
Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
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Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence of comparable bilateral-walled intrabony defects
大体时间：6 months postoperatively
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Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth. |
6 months postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical attachment level
大体时间：6 months postoperatively
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Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth
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6 months postoperatively
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Interproximal probing depth
大体时间：6 months postoperatively
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Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth
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6 months postoperatively
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Gingival margin
大体时间：6 months postoperatively
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Gingival margin will be measured from the cemento-enamel junction (CEJ).
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6 months postoperatively
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Bleeding on probing
大体时间：6 months postoperatively
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Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus
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6 months postoperatively
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Plaque index
大体时间：6 months postoperatively
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Plaque index (PI) will be measured for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin
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6 months postoperatively
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 23110280p
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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