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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
capsule 0.5 mg once a day
capsule, once a day
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
Time frame: 6 months
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
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