Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
2 other identifiers
observational
45
1 country
1
Brief Summary
This study will examine common features of gingival overgrowth (excessive growth of the gums around the teeth) that develops in patients with the hereditary form of the condition and in those who develop the condition as a side effect of medications. A better understanding of gingival overgrowth may help scientists develop medications with fewer oral side effects. Patients of any age with hereditary gingival fibromatosis and their blood relatives, and patients of any age with gingival overgrowth who are taking medications associated with development of the disorder, including phenytoin (diphenylhydantoin or Dilantin), cyclosporine, and calcium-channel blockers, may be eligible for this study. Participants undergo a medical and dental history, including a history of medication use; detailed examination of the teeth, periodontium, head, and neck; photographs of teeth with gingival overgrowth; dental x-rays; and blood tests. DNA is extracted from a blood sample to look for genes related to gingival overgrowth. Patients with gingival overgrowth are offered two options, as follows:
- Tissue biopsy: A tissue sample is taken from each affected site, with a maximum of three biopsies. For the procedure, lidocaine is first injected into the gum to numb the tissue. Then, a cookie-cutter instrument is pushed into the numbed skin, and a small piece of tissue is removed.
- Gingivectomy: Surgical removal of the overgrown gingival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2005
CompletedFirst Submitted
Initial submission to the registry
February 18, 2005
CompletedFirst Posted
Study publicly available on registry
February 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2011
CompletedJuly 2, 2017
April 19, 2011
February 18, 2005
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients of any age, gender, and racial/ethnic group with hereditary gingival fibromatosis (HFG) as diagnosed with HGF by clinical appearance that consists of attached gingival covering the lower 1/3 or more of the clinical crowns of teeth in an individual not taking medications associated with gingival changes.
- Blood relatives of affected individuals who are at risk of inheriting HGF.
- Patients of any age, gender, and racial/ethnic group taking one of the three medications associated with drug-induced gingival overgrowth (phenytoin diphenylhydantoin or Dilantin, cyclosporine, or calcium-channel blockers).
- Patients with six or more teeth.
You may not qualify if:
- Patients with significant cognitive impairment.
- Pregnant patients or lactating patients.
- Patients unwilling to give informed consent.
- Patients with less than six teeth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Boratynska M, Radwan-Oczko M, Falkiewicz K, Klinger M, Szyber P. Gingival overgrowth in kidney transplant recipients treated with cyclosporine and its relationship with chronic graft nephropathy. Transplant Proc. 2003 Sep;35(6):2238-40. doi: 10.1016/s0041-1345(03)00800-5.
PMID: 14529900BACKGROUNDCasetta I, Granieri E, Desidera M, Monetti VC, Tola MR, Paolino E, Govoni V, Calura G. Phenytoin-induced gingival overgrowth: a community-based cross-sectional study in Ferrara, Italy. Neuroepidemiology. 1997;16(6):296-303. doi: 10.1159/000109700.
PMID: 9430129BACKGROUNDEllis JS, Seymour RA, Taylor JJ, Thomason JM. Prevalence of gingival overgrowth in transplant patients immunosuppressed with tacrolimus. J Clin Periodontol. 2004 Feb;31(2):126-31. doi: 10.1111/j.0303-6979.2004.00459.x.
PMID: 15016038BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 18, 2005
First Posted
February 21, 2005
Study Start
February 15, 2005
Study Completion
April 19, 2011
Last Updated
July 2, 2017
Record last verified: 2011-04-19