NCT02366585已完成2 期
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
PerioC Limited1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
The main purpose of the trial is to investigate the effect of locally delivered ciclosporin as an adjunct to non-surgical mechanical debridement in the treatment of chronic periodontitis and to compare it to mechanical debridement alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in good general health
- •2 pairs of contralateral interproximal periodontal sites with probing depths of ≥7mm in single-rooted teeth not associated with furcations or root furrows.The test sites should have a distance of at least two teeth to the control sites.
- •Teeth selected should have a vital pulp as determined by thermal or electric stimulation
排除标准
- •Patients already included in other clinical trials involving therapeutic intervention (either medical or dental)
- •Periodontal treatment during the last 6 months
- •Antibiotic treatment 6 months prior to the start of the trial
- •Antibiotic prophylaxis required for dental treatment
- •Patients with acute infectious lesions in the areas of intended treatment
- •Regular anti-inflammatory medication
- •Known history of ciclosporin allergy
- •Ongoing medication that may affect the clinical features of periodontitis
- •Patients who are smokers
- •Patients that are immuno-compromized or on immunosuppressive medication
- •Patients who are pregnant or lactating
研究组 & 干预措施
Treatment with Ciclosporin
Experimental
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
干预措施: Ciclosporin (Drug)
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: 3 months
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Bleeding on Probing (BoP)
时间窗: 3 months
Change in BoP (measured as present or absent) from baseline to 3-month examination
次要结局
未报告次要终点
研究者
研究点 (1)
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