Simplified Papilla Preservation Flap(SPPF) and Enamel Matrix Derivative(EMD) With or Without Connective Tissue(CTG) Wall for the Treatment of Non Contained Infrabony Defects. A Randomized Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- clinical attachment gain
研究概览
简要总结
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .
详细描述
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .The objectives is to assess the probing pocket depth reduction, clinical attachment level gain,gingival recession depth and radiographic bone gain. The TEST group will be treated withSIMPLIFIED PAPILLA PRESERVATION flap with connective tissue graft and enamel matrix derivative and the CONTROL group will be treated with SIMPLIFIED APILLA PRESERVATION flap and enamel matrix derivative. The total number of participants included will be 30 (Control-15; Study-15) with a 6 month follow up.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients willing to participate in the study.
- •Participants aged ≥18 years to 55 years.
- •Presented with non contained infra bony defects.
- •Presence of at least 1 non contained infra bony defect(IBD) with a pocket probing depth ≥6mm after reevaluation of the hygienic phase and a depth of IBD ≥3mm as detected on radiographs, with radiographic angulation of ≥37⸰ , and exhibiting a 1 or 2 wall infra bony defect15(assessed by a bone sounding and confirmed intrasurgically)
- •Patient's full mouth plaque score and bleeding score <20% at the time of surgical procedure.
- •No history of periodontal surgery at the experimental site.
排除标准
- •Grade III mobility, endodontically treated teeth.
- •Pregnant and lactating females.
- •History of tobacco smoking .
- •Patients with systemic disease.
- •Known allergy or hypersensitivity to EMD.
- •Presence of pulpal and peri apical involvement
结局指标
主要结局
clinical attachment gain
时间窗: 6 months
change in attachment level for patient with isolated 2 or 3 wall defect treated with enamel matrix derivative and connective tissue wall graft in 1,3 and 6 months follow up
次要结局
- pocket probing depth(6 months)
- recession reduction(6 months)
- plaque index(6 months)
- gingival index(6 months)
- radiographic bone gain(6 months)