Effects of Vitamin D on Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 主要终点
- Attachment Loss (AL)
研究概览
简要总结
The object of the study was to evaluate the direct effect of high dose vitamin D supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.
详细描述
Periodontitis is a chronic inflammatory disease characterized by periodontal tissues inflammation and alveolar bone loss. Vitamin D is involved in stimulating osteoblasts to enable normal bone growth and preservation, also the regulation of cellular proliferation, differentiation, innate immune response and anti-inflammatory effect.Previous studies have reported the association of vitamin D levels and gingivitis and periodontitis. This study was designed as a randomized controlled trial to evaluate the effect of vitamin D supplementation on chronic periodontitis.
The study was divided into two phases. Recruitment including baseline clinical measurements was obtained and standard periodontal treatments were performed in Phase One. The randomization and intervention of vitamin D were performed in Phase Two. The 323 subjects were randomly divided into 3 groups (n=105,110,108) to receive a supplement kit containing 90 capsules of 2000 IU vitamin D, 1000 IU vitamin D, or placebo capsule for 3 months. After intervention, all the subjects were followed up after 3 months and received standard periodontal examination, including attachment loss (AL), probing depth (PD), bleeding index (BI), and panoramic radiographs were taken to evaluate alveolar crest height (ACH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 30 years old to 70 years old
- •More than 20 teeth remaining in the mouth
- •Clinical diagnosis of moderate to severe periodontitis
- •Not receiving periodontal treatment within 6 months
- •Not taking antibiotic drugs within 3 months.
排除标准
- •Diabetes, thyroid and parathyroid endocrine associated diseases
- •Severe systemic diseases, such as cancer
- •Taking vitamin D and / or calcium drugs during observation
- •Taking aspirin, non-steroidal anti-inflammatory drugs, and steroids
- •Pregnant or prepare to pregnant within one year
- •Have been suffering from hypercalcemia, malabsorption syndrome.
研究组 & 干预措施
1000IU/day
Subjects took 1000IU vitamin D per day
干预措施: vitamin D (Dietary Supplement)
2000IU/day
Subjects took 2000IU vitamin D per day
干预措施: vitamin D (Dietary Supplement)
Placebo
Subjects took placebo
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
Attachment Loss (AL)
时间窗: 6 months after periodontal treatment
Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects
次要结局
- Probing Depth (PD)(6 months after periodontal treatment)
- Alveolar Crest Height (ACH)(6 months after periodontal treatment)
- Bleeding Index (BI)(6 months after periodontal treatment)
研究者
Zuo Min Wang
Dean of Stomatology Department, Beijing Chao-Yang Hospital
Beijing Chao Yang Hospital