Effectiveness of Hyaluronic Acid (hyaDENT BG® Gel) Compared With Enamel Matrix Proteins (Emdogain®) in the Treatment of Angular Bone Defects in Combination With a Xenograft (Bio-Oss Collagen®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- periodontal pocket depth reduction
研究概览
简要总结
The goal of this clinical trial is to learn whether hyaluronic acid (HyaDent® BG) provides similar benefits to Emdogain® when both are used with Bio-Oss® Collagen during periodontal surgery in adults with periodontal (intrabony) defects. The main questions it aims to answer are:
Does the treatment reduce probing pocket depth?
Does the treatment increase clinical attachment level?
Does the treatment increase radiographic bone fill?
Does the treatment change the gingival margin position?
Researchers will compare Bio-Oss Collagen + HyaDent BG with Bio-Oss Collagen + Emdogain to see whether HyaDent BG achieves similar improvements in clinical and radiographic outcomes as Emdogain.
Participants will:
Undergo periodontal surgery to treat the vertical bone defect(s), with either Bio-Oss Collagen + HyaDent BG or Bio-Oss Collagen + Emdogain.
Attend follow-up visits for periodontal measurements and radiographs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Adults over the age of 18 diagnosed with periodontal disease-Stage III or IV periodontitis;
- •Sites with bone defects and a probing pocket depth (PPD) ≥ 6 mm, accompa-nied by bleeding on probing (BoP) at re-evaluation, conducted six weeks after non-surgical periodontal therapy;
- •Full Mouth Plaque Score (FMPS) < 20% and Full Mouth Bleeding Score (FMBS) < 15% prior to surgical treatment;
- •Good general health with no systemic conditions and no known allergies to materials or medications used in the study.
排除标准
- •Medical conditions contraindicating surgical intervention;
- •Pregnancy or lactation;
- •Heavy smokers;
- •Untreated periodontal disease;
- •Poor oral hygiene;
- •Acute infectious lesions in the area of intervention;
研究组 & 干预措施
Bio-Oss Collagen + HyaDent BG
Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel). The procedure follows standard periodontal surgical protocols.
干预措施: Bio-Oss Collagen + HyaDent BG (Biological)
Bio-Oss Collagen + Emdogain
Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols.
干预措施: Bio-Oss Collagen + Emdogain (Biological)
结局指标
主要结局
periodontal pocket depth reduction
时间窗: Before the surgery and 6 moths after the surgery
Clinical attachment gain
时间窗: Before the surgery and 6 months after surgery
Radiographic bone fill
时间窗: Before and 6 months after surgery.
次要结局
未报告次要终点
研究者
Hristina Maynalovska
Chief Assistant
Medical University of Sofia