Effect of Folic acid supplementation on Desquamative gingivitis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Healing outcome of the lesion(Complete regression/partial regression/No Regression)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Desquamative Gingivitis Lesion presenting as erythema, burning sensation, desquamation, ulceration of gingiva and associated oral mucosa.
Exclusion Criteria
- •Dental plaque induced inflammatory diseases of gingiva such as gingivitis and periodontitis.
- •Oral Candidiasis.
- •Acute Herpetic gingivostomatitis.
- •Acute Necrotizing ulcerative gingivitis.
Outcomes
Primary Outcomes
1. Healing outcome of the lesion(Complete regression/partial regression/No Regression)
Time Frame: Baseline, 2 weeks post intervention
2.Change in the surface area of the lesion(mm2)
Time Frame: Baseline, 2 weeks post intervention
3. Visual analog score for assessing reduction in pain perception(0 to 10 scale)
Time Frame: Baseline, 2 weeks post intervention
Secondary Outcomes
- Plaque Index(Gingival Index)