Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recession depth (RD)
研究概览
简要总结
A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
详细描述
IN TEST SITE :
Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
IN CONTROL SITE:
Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.
排除标准
- •Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study
研究组 & 干预措施
EGF impregnated in collagen membrane
EGF impregnated in collagen membrane is placed in gingival recession defects
干预措施: RhEGF (Drug)
plain collagen membrane
plain collagen membrane is placed in gingival recession defects
干预措施: Plain Collagen (Drug)
结局指标
主要结局
Recession depth (RD)
时间窗: Base line to 6months.
Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.
次要结局
- Width of keratinized gingiva (KGW)(Base line to 6months.)
研究者
Dr R Viswa Chandra
Primary Investigator
SVS Institute of Dental Sciences