A Randomized Controlled Trial for reinforcement of epithelial barrier function by vitamin D induction of the antimicrobial peptide cathelicidine. A novel therapeutic approach in Chronic periodontitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Increase in GCF cathelicidine levels.
研究概览
简要总结
Chronic Periodontitis is an inflammatory destructive disease of the periodontium resulting in damage to the epithelial barrier , the first line of defence which prevents the entry of microorganisms.Untreated periodontitis progressively results in tooth mortality which has significant social and economic burden on the patients.With shifting paradigms in health care facilities from cure to prevention much emphasis has been laid upon prevention of disease process at the primary level.
There are 3 barriers against infection namely physical,chemical and immunological.The chemical barrier mainly comprises of anti microbial peptides (AMPs) which are endogenously produced antibiotics.
Defensins and Cathelicidines are the most powerful AMPs detected in oral cavity.
The link between upscaling of AMP function and vitamin D is well established.Thus an increase in vitamin D should significantly improve the chemical barrier function by increasing AMPs.
This study intends to explore an economically viable , easily available and a well accepted molecule like vitamin D in primary prevention of chronic periodontitis by reinforcing the epithelial barrier through increased action of Cathelicidine thus reducing a cascade of events which results in tooth mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Inclusion Criteria : 1.Study subjects should be >25 years of age.
- •2.Patients suffering from chronic periodontitis i.e. a)Bleeding on probing b)Probing pocket depth of ≥ 5 mm c)Clinical attachment loss of ≥ 3 mm 3.Patients should be vitamin D sufficient (serum levels 30ng/ml and above) according to vitamin D council.
- •4.Systemically healthy individuals with minimum 20 teeth in occlusion.
排除标准
- •Exclusion Criteria: 1.Patients with systemic diseases that can impair immune response such as diabetes mellitus, HIV, immunological disorder and hepatitis.
- •2.Patients on any systemic antibiotics, NSAIDS, steroid therapy and any other drugs which is known to affect the periodontal status.
- •3.Smokers and former smokers are excluded from the study.
- •4.Patients who have received periodontal treatment in the preceding year or who have taken antibiotics within the previous 3 months.
- •5.Pregnant or lactating women and those taking oral contraceptive drugs.
结局指标
主要结局
Increase in GCF cathelicidine levels.
时间窗: 90 days.
次要结局
- Improvement in epithelial barrier function(90 days)
