The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
研究概览
简要总结
48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
- •bleeding on probing (BOP),
- •mobility ≤degree 1 and
- •no furcation involvement.
排除标准
- •full mouth plaque score >20%,
- •uncontrolled systemic disease,
- •history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
- •pregnant or lactating females,
- •drug and alcohol abuse,
- •smoking >10 cigarettes per day and
- •inadequate restorative therapy or malocclusion.
结局指标
主要结局
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
时间窗: 12 months
probing pocket depth (PPD)
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
时间窗: 12 months
bleeding on probing (BOP)
次要结局
- frequencies of pocket closure(12 months)
研究者
Mahmoud Abu-Ta'a
Associate Professor
Arab American University (Palestine)