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临床试验/CTRI/2018/03/012813
CTRI/2018/03/012813招募中2/3 期

Effect of Folic acid supplementation on Desquamative gingivitis

Dr Saif Khan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
1. Healing outcome of the lesion(Complete regression/partial regression/No Regression)

研究概览

简要总结

Desquamative  gingivitis (DG) is a non-plaque induced lesions of the oral mucosa, characterised by erythema, erosion, desquamation of the gingival   and  associated  oral mucosa .These lesions are quite unpredictable in their clinical course and are quite challenging for the clinician to treat, as sometimes they are refractory to current standard  therapeutic modality. Folic acid is one of the vitamin B complex, acts as co factor   in  DNA methylation which is essential for DNA synthesis and repair.Evidence has shown that  folic acid supplementation plays   important role in chemoprevention of gastric carcinogenesis by   increasing epithelial apoptosis in premalignant lesions by up regulating   P53 gene and down regulating Bcl-2 gene. It has been shown in double-blind randomized trials that folic acid both in systemic supplementation and local delivery increased the resistance of gingival cells to local irritants and decreased gingival inflammation .In the light of above evidence we propose to study the effect of Folic acid supplementation on DG with the objective to compare the clinical outcomes and salivary TNF-alpha levels in DG patients receiving standard local steroid therapy versus standard local steroid therapy with adjunct systemic oral folic acid supplementation.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Desquamative Gingivitis Lesion presenting as erythema, burning sensation, desquamation, ulceration of gingiva and associated oral mucosa.

排除标准

  • Dental plaque induced inflammatory diseases of gingiva such as gingivitis and periodontitis.
  • Oral Candidiasis.
  • Acute Herpetic gingivostomatitis.
  • Acute Necrotizing ulcerative gingivitis.

结局指标

主要结局

1. Healing outcome of the lesion(Complete regression/partial regression/No Regression)

时间窗: Baseline, 2 weeks post intervention

2.Change in the surface area of the lesion(mm2)

时间窗: Baseline, 2 weeks post intervention

3. Visual analog score for assessing reduction in pain perception(0 to 10 scale)

时间窗: Baseline, 2 weeks post intervention

次要结局

  • Plaque Index(Gingival Index)

研究者

发起方
Dr Saif Khan
申办方类型
Other []

研究点 (1)

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