Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
This study is currently recruiting patients
Verified by National Institutes of Health Clinical Center (CC) November 2006
| Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
| Information provided by: |
National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: |
NCT00104026 |
Purpose
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.
| Condition
|
| Gingival Overgrowth |
Study Type: Observational
Study Design: Natural History
Official Title: Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
Further study details as provided by National Institutes of Health Clinical Center (CC):
Expected Total Enrollment:
600
Study start: February 2005
The purpose of this protocol is twofold: 1) to continue identification of genes associated with hereditary gingival fibromatosis
(HGF), a type of gingival overgrowth 2) to investigate the genes up-regulated by medications that induce gingival overgrowth.
These studies will establish if common mechanisms are involved in the hereditary and drug-induced processes. If a common
pathway is identified, it could lead to the development of assays that could be used to screen new medications for their potential
deleterious effects on periodontal tissues. In addition, understanding the mechanisms involved in gingival overgrowth could
lead to the development of tissue engineering approaches to repair gingival defects. Genes will be identified from DNA samples
collected from patients with hereditary gingival fibromatosis. These will be compared with DNA and tissue samples taken from
patients taking medications known to induce gingival overgrowth (phenytoin, cyclosporine and calcium channel blockers).
Eligibility
Genders Eligible for Study:
Both
Accepts Healthy Volunteers
Criteria
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.
EXCLUSION CRITERIA:
Patients with significant cognitive impairment.
Pregnant patients or lactating patients.
Patients unwilling to give informed consent.
Patients with less than six teeth.
Patients unable to sign informed consent will be excluded from the study.
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00104026
Maryland National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda,
Maryland,
20892,
United States; Recruiting
North Carolina Wake Forest University, Winston-Salem,
North Carolina,
27103,
United States; Recruiting
Pennsylvania University of Pittsburgh, Pittsburgh,
Pennsylvania,
15261,
United States; Recruiting
Brazil Universidade de Taubate, Taubate,
Brazil; Recruiting
More Information
NIH Clinical Center Detailed Web Page
Publications
Ellis 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.
Study ID Numbers:
050103; 05-D-0103
Last Updated:
December 12, 2006
Record first received:
June 19, 2006
ClinicalTrials.gov Identifier:
NCT00104026Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-12-26
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