Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00104026
Recruitment Status : Completed
First Posted : February 21, 2005
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date February 18, 2005
First Posted Date February 21, 2005
Last Update Posted Date July 2, 2017
Study Start Date February 15, 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00104026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
Official Title Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
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.
Detailed Description 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).
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Gingival Overgrowth
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2010)
45
Original Enrollment
 (submitted: June 23, 2005)
600
Study Completion Date April 19, 2011
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number NCT00104026
Other Study ID Numbers 050103
05-D-0103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 19, 2011