Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen. A 12-month Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL) change
研究概览
简要总结
To compare the healing of intrabony periodontal defects treated with either open flap debridement and a volume-stable collagen matrix (VCMX) or a deproteinized bovine bone mineral with 10% collagen. The results will shed light on the clinical potential of VCMX in regenerative periodontal surgery and help to develop new treatment strategies.
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
- •Patients with localized or generalized periodontitis Stage III and Stage IV, Grade A-B-C
- •Males and females
- •Age at least 18 years and older
- •Presence of interdental intra-bony defects (I, II and III walls) in either the maxilla or the mandible with a PD ≥ 6 mm
- •Defects with an intra-bony component > 3 mm for both groups
- •Intra-bony defect located only at one aspect (mesial or distal)
- •Presence of at least 2 mm of keratinized soft tissue.
排除标准
- •Patients with systemic disease that could interfere with periodontal wound healing
- •Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
- •Pregnant or lactating
- •Smokers with > 10 cig./day
- •Patients with FMPS and FMBS > 25 % after completion of non-surgical periodontal therapy
- •Multi-rooted teeth with furcation involvement
- •Third molars
- •Teeth with circumferential defects
- •Interdental craters
- •Written Informed Consent
研究组 & 干预措施
Test Group (VCMX)
The periodontal infrabony defect will be opened by a papilla preservation flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with a volume-stable collagen matrix (VCMX) only.
干预措施: Infrabony defects will be filled with a volume-stable collagen matrix (VCMX) (Device)
Control Group (Deproteinized bovine bone mineral)
The periodontal infrabony defect will be opened by a flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with deproteinized bovine bone mineral with 10% collagen.
干预措施: Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen (Device)
结局指标
主要结局
Clinical attachment level (CAL) change
时间窗: 12 months
Clinical attachment level (CAL) change in mm: the distance from the cemento-enamel junction to the bottom of the clinical periodontal pocket is being measured
次要结局
- Microbiological analysis(1, 3, 12 weeks)
- Bleeding on probing (BoP)(Baseline, 12 months)
- Pocket probing depth (PPD)(Baseline, 12 months)