Gingival Overgrowth
Conditions
Keywords
phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade
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.
Interventions
DRUGfolic acid
capsule 0.5 mg once a day
DRUGplacebo
capsule, once a day
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy | 6 months |
Secondary
| Measure | 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 | 6 months |
Countries
India
Outcome results
None listed