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Completed

NCT Number: NCT00781196

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

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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Key information

Conditions

Gingival Overgrowth Gingival Diseases Gingival Hyperplasia Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Drug

capsule 0.5 mg once a day

Placebo

Drug

capsule, once a day

Primary outcomes

  1. Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy

    Time frame: 6 months

Secondary outcomes

  1. Occurrence of grade > 2 hyperplasia at the end of 6 mo

    Time frame: 6 months

  2. Time to occurrence of grade > 2 overgrowth

    Time frame: open

  3. Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.

Acronym: PIGO

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 28, 2008
Registry last updated
Aug 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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