Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)

All India Institute Of Medical Science (AIIMS)

Status and phase: Completed; Phase 3

Conditions: Gingival Overgrowth

Treatments: Drug: placebo; Drug: folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00781196

PIGO

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 6-15 yr
• Started on phenytoin 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 months
• Pre-existing gingival over-growth due to other cause

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Oral folic acid

Treatment:

Drug: folic acid

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo