Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change of furcation grade level
研究概览
简要总结
Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be ≥ 20 years
- •Subject must have periodontal disease as determined by the World Workshop 2017 criteria
- •Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
- •Competent to give consent
排除标准
- •The following must not be present at the time of enrolment;
- •Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
- •Present or past use of bisphosphonate treatment
- •Pregnant or nursing subjects
- •Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
- •Previous surgical therapy of included furcation defects
- •Inability to comprehend and respond to the quality of life questionnaire
- •Dental restorations or prosthesis involving the furcation area
- •Root fractures or suspected infractions
- •Caries lesions in the furcation area
- •No systemic antibiotic treatment within 3 months prior to intervention
研究组 & 干预措施
Regenerative therapy w/BCP and collagen membrane
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
干预措施: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) (Device)
Regenerative therapy w/BCP and collagen membrane
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
干预措施: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) (Drug)
Regenerative therapy w/BCP and enamel matrix proteins
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
干预措施: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) (Device)
Regenerative therapy w/BCP and enamel matrix proteins
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
干预措施: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) (Drug)
结局指标
主要结局
Change of furcation grade level
时间窗: 24 months after treatment
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
次要结局
- Changes in CAL(24 months after treatment)
- Changes in PPD(24 months after treatment)
- Radiographic changes(24 months after treatment)
- Caries assessment(24 months)
- Changes in patient-reported quality of life (QoL)(Preoperatively compared to 12 months after treatment)
- Changes in defect morphology assessed by CBCT(24 months after treatment)
- Pain following surgery(Daily for 1 week postoperatively)
研究者
Anders Verket
Associate Professor
University of Oslo