NCT03269799Unknown2 期
The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- sulcus bleeding index
研究概览
简要总结
Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at the end of week 4 and at the end of week 8.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncontrolled type 2 diabetes mellitus
- •periodontitis
排除标准
- •complications from diabetes mellitus, e.g., renal insufficiency
- •receive insulin
- •diseases that interfere with wound healing, e.g., HIV
- •receive one of the followings: tetracycline, acetaminophen, NSAID, warfarin, aluminum-containing antacids, barbiturates, phenobarbital, pentobarbital, secobarbital, hormone replacement therapy, chemotherapeutic drug, protease inhibitor
- •receive other vitamins or antibiotics within 6 months
- •pregnancy
研究组 & 干预措施
test group
Active Comparator
vitamin C 500 mg oral capsule
干预措施: Vitamin C 500 MG Oral Capsule (Drug)
control group
Placebo Comparator
placebo
干预措施: placebo (Other)
结局指标
主要结局
sulcus bleeding index
时间窗: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
次要结局
未报告次要终点
研究者
Supanee Rassameemasmaung
Associate Professor
Mahidol University
研究点 (1)
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