NCT07183631已完成4 期
Evaluating Treatment of Intra-bony Defects With PRF or EMD
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
Objective: To evaluate clinically the long-term results following treatment of deep intrabony defects with either platelet-rich fibrin gel (PRF) or an enamel matrix derivative (EMD).
Methods: Twenty six patients diagnosed with advanced chronic periodontitis, and each of whom displaying one deep intrabony defect were randomly treated with open flap debridement and with either PRF (test) or EMD (Emdogain, Straumann, Basel, Switzerland) (control). The clinical outcomes were evaluated at baseline, at six months and three years after treatment. The primary outcome variable was the clinical attachment level (CAL).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No systemic conditions affecting treatment outcomes
- •Good oral hygiene [plaque index (PI) <1; Löe 1967]
- •Compliance with the maintenance program
- •Presence of at least one intra-bony defect with a probing depth (PD) of ≥6 mm and an intra-bony component of ≥3 mm confirmed by radiographs.
排除标准
- •significant medical conditions: irradiation in the maxillofacial area, uncontrolled diabetes or hypertension, systemic steroid or bisphosphonate treatment, pregnancy, or lactation, infectious diseases,
- •age <18 years, (3) smokers (>5 cigarettes/day),
- •high residual inflammation (FMBS >25%),
- •poor oral hygiene (FMPS >25%), and
- •defect-related factors: furcation involvement, endo-perio defects, horizontal defects, or multi-tooth defects .
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: preop and after 6 months
次要结局
- Gingival recession(preop and after 6 months)
- Clinical attachment loss(preop and after 6 months)
研究者
Eleonora Solyom
Assistant Lecturer
Semmelweis University
研究点 (2)
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