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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral folic acid |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folic acid | Drug | capsule 0.5 mg once a day |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of grade > 2 hyperplasia at the end of 6 mo | 6 months | |
| Time to occurrence of grade > 2 overgrowth | open | |
| Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21482950 | Derived | Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children. Neurology. 2011 Apr 12;76(15):1338-43. doi: 10.1212/WNL.0b013e3182152844. |
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| ID | Term |
|---|---|
| D019214 | Gingival Overgrowth |
| D005885 | Gingival Hyperplasia |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
capsule, once a day |
|
| 6 months |
| D006571 | Heterocyclic Compounds |