NCT01405365Unknown不适用
The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases
Federal University of Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).
详细描述
Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI >30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments:
- scaling and root planing + placebo
- scaling and root planing + metronidazole
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, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal weight or obese (according to BMI)
- •nonsmokers or former smokers (3 or more years)
- •no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
- •have 10 teeth present
- •have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm
排除标准
- •Pregnancy
- •Development of diabetes or other conditions that may impair periodontal healing
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Scaling and root planning (Procedure)
Metronidazole
Experimental
干预措施: Metronidazole (Drug)
Metronidazole
Experimental
干预措施: Scaling and root planning (Procedure)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Probing depth
时间窗: 12 months
Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
次要结局
- Attachment level(12 months)
研究者
研究点 (1)
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