Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- 2D Radiographic Healing at 12 Months Follow up (Overall Cases)
研究概览
简要总结
The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.
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
- 是
入选标准
- •Healthy adult.
- •Intact coronal restoration with no sign of leakage.
- •Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)
排除标准
- •Patients with medical conditions and contraindications to surgery.
- •Pregnancy.
- •Teeth with signs of coronal leakage.
- •Teeth with vertical root fractures.
研究组 & 干预措施
Treatment
Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA).
干预措施: Foundation (Device)
Control
Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only.
结局指标
主要结局
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
时间窗: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
时间窗: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
时间窗: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing.
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
时间窗: 12 months
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
次要结局
- C Score (Asymptomatic Cases Only)(12 months)
- C Score (Overall Cases)(12 months)