Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in pocket depth
研究概览
简要总结
In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic periodontitis
- •two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss > 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
- •systemically healthy volunteers
排除标准
- •need for antibiotic or systemic/local antibiotic use in the previous 3 months
- •periodontal treatment in the previous 6 months
- •pregnancy or lactation
- •immunological disorders or imune suppressive treatments
- •orthodontic appliances or removable prosthesis
- •osteoporosis
- •known or suspected allergy to biphosphonates
- •systemic use of biphosphonates
研究组 & 干预措施
Sodium Alendronate
Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
干预措施: Sodium alendronate (Drug)
Placebo
Adjunctive use of placebo gel as part of periodontitis treatment
干预措施: Placebo (Other)
结局指标
主要结局
Changes in pocket depth
时间窗: baseline and 3- and to 6-month evaluations
Reductions in pocket depth overtime
Changes in clinical attachment level
时间窗: baseline and 3- and to 6-month evaluations
Gain in clinical attachment level overtime
次要结局
- Changes in bone defects(Baseline and 6 months)
研究者
Bernardo de Carvalho Dutra
Clinical evaluation and treatment for the effect of image periodontal mechanical non surgical associated with application of topical alendronate sodium a 1% repair periodontal: randomized controlled clinical trial
Federal University of Minas Gerais