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Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)

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ClinicalTrials.gov Identifier: NCT00781196
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : August 4, 2009
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gingival Overgrowth Drug: folic acid Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Oral folic acid
 Drug: folic acid
capsule 0.5 mg once a day
Placebo Comparator: 2
placebo
 Drug: placebo
capsule, once a day


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781196


Locations
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India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ravindra Arya, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00781196    
Other Study ID Numbers: PIGO
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Keywords provided by All India Institute of Medical Sciences, New Delhi:
phenytoin
gum hyperplasia
phenytoin induced gingival overgrowth
plaque index
gingival overgrowth grade
Additional relevant MeSH terms:
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Gingival Overgrowth
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Folic Acid
Hematinics
 Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs