Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- change from baseline vertical height of ridge at 6 months
研究概览
简要总结
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.
详细描述
The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Need for molar extraction due to periodontal disease and plan for late implantation
- •No acute infection, such as abscess or effusion
- •Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
- •Presence of one adjacent tooth to the extraction site
排除标准
- •Pregnancy or lactation
- •Untreated periodontal disease
- •Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
- •Under radiotherapy
- •Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
- •Extraction of multiple adjacent teeth
- •Allergy to any of the materials used in the study
结局指标
主要结局
change from baseline vertical height of ridge at 6 months
时间窗: baseline, at 6 months
vertical height of ridge at the buccal and palatal/lingual plates
change from baseline horizontal width of ridge at 6 months
时间窗: baseline, at 6 months
horizontal width of ridge at 1, 3, 5mm below crest
次要结局
- width of keratinized tissue(at 6 months)
- thickness of mucosa(at 6 months)
- postoperative pain(at 2 weeks)
研究者
Peihui Ding
Principal Investigator
The Dental Hospital of Zhejiang University School of Medicine