Clinical Trial: Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
Brief Summary: Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.
Detailed Summary:
Sponsor: All India Institute of Medical Sciences, New Delhi
Current Primary Outcome: Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of grade > 2 hyperplasia at the end of 6 mo [ Time Frame: 6 months ]
- Time to occurrence of grade > 2 overgrowth [ Time Frame: open ]
- Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: All India Institute of Medical Sciences, New Delhi
Dates:
Date Received: October 27, 2008
Date Started: May 2008
Date Completion:
Last Updated: August 3, 2009
Last Verified: August 2009
