Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Clinical attachment level (CAL)
研究概览
简要总结
The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of aggressive periodontitis in line with American Academy of Periodontology classification (Lang et al. 1999)
- •Familial aggregation (history of periodontitis in parents or siblings)
- •Presence of at least two teeth with probing pocket depth (PPD) ≥ 6mm and clinical attachment level (CAL) ≥ 5 mm associated with an intrabony defect of at least 3 mm as detected in diagnostic periapical radiographs
- •No furcation involvement of the teeth presenting the intraosseous defects
- •The width of keratinized tissue on the facial aspect of the selected teeth ≥ 2 mm
排除标准
- •Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
- •Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
- •Smoking more than 10 cigarettes/day
- •Systemic diseases with compromised healing potential of infectious diseases
- •Drugs affecting periodontal health / healing
- •Pregnant and lactating females
- •Previous periodontal surgery in the area
研究组 & 干预措施
GTR + radiation-sterilize allogenic bone graft (TEST)
The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of radiation-sterilized allogenic bone graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures.
干预措施: GTR + radiation-sterilize allogenic bone graft (Device)
GTR + xenogenic graft (CONTROL)
The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of xenogenic graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures.
干预措施: GTR + xenogenic graft (Device)
结局指标
主要结局
Change in Clinical attachment level (CAL)
时间窗: Baseline and 12 months after surgery
CAL will be measured in millimeters on the study teeth at 6 locations as a distance from the cementoenamel junction to the bottom of the gingival sulcus. The average differences between 12 months and baseline measurements at the sites with the most advanced attachment loss at baseline will be compared.
次要结局
未报告次要终点