Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)
Phase 3
- Registration Number
- CTRI/2008/091/000227
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Age: 5-15 yr
Started on PHT within 1 mo of enrollment
Exclusion Criteria
Not willing to participate
On other folic acid antagonists e.g. anti-neoplastic drugs for >/= 2 wks during last 3 mo
Pre-existing gingival over-growth due to other cause
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapyTimepoint: 6 mo
- Secondary Outcome Measures
Name Time Method Occurrence of grade > 2 hyperplasia at the end of 6 moTimepoint: 6 mo