Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects: A Randomized, Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Linear bone growth
研究概览
简要总结
The aim of the present study was to evaluate the bone formation potential of 400µg alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.
详细描述
The aim of the present study was to evaluate the bone formation potential of 400µg alendronate(ALN) delivered in β-TCP in the treatment of periodontal intra-osseous defects.
Materials and Methods
Thirty patients with periodontal defects were randomly assigned to 400µg ALN + β-TCP + saline (test) group and β-TCP + saline (active-control) group. Clinical parameters like clinical attachment level (CAL) gain, probing depth (PD) reduction, post-operative gingival recession (GR) were assessed from the baseline, 3 months and 6 months recordings. Radiographic parameters like linear bone growth (LBG), percentage bone fill (%BF), change in alveolar crest height (ACH) were assessed from baseline and 6 months radiographs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients having an intra-osseous defect with probing depth ≥ 7mm at baseline, presence of a ≥ 4mm vertical inter-proximal bone defect with at least one bony wall after surgical debridement and with no history of previous periodontal therapy were included into the study
排除标准
- •Patients with known systemic diseases, aggressive periodontitis, smoking habit, known or suspected allergy to bisphosphonates, pregnant and lactating women, study tooth exhibiting tooth mobility greater than grade II and class III furcation defect were excluded from the study.
研究组 & 干预措施
Test group
400µg Alendronate sodium+ β-TCP + saline. 400µg alendronate sodium is combined with beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.
干预措施: Alendronate sodium (Drug)
Test group
400µg Alendronate sodium+ β-TCP + saline. 400µg alendronate sodium is combined with beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.
干预措施: beta-tricalcium phosphate bone substitute (Biological)
Control group
β-TCP + saline Beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.
干预措施: beta-tricalcium phosphate bone substitute (Biological)
结局指标
主要结局
Linear bone growth
时间窗: change from baseline and 6 months
Linear bone growth (LBG) was calculated as the difference between the cemento-enamel junction(CEJ) to base of defect (BD) distance at baseline and CEJ to BD distance at 6 months in radiographs.
次要结局
- clinical attachment level (CAL)(change from baseline and 6 months)
研究者
Rohini Naineni, MDS
Reader
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre