Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
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|ClinicalTrials.gov Identifier: NCT00104026|
Recruitment Status : Completed
First Posted : February 21, 2005
Last Update Posted : July 2, 2017
|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|
|Brief Title||Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth|
|Official Title||Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth|
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:
|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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||April 19, 2011|
|Primary Completion Date||Not Provided|
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.
Patients with significant cognitive impairment.
Pregnant patients or lactating patients.
Patients unwilling to give informed consent.
Patients with less than six teeth.
|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|
|Other Study ID Numbers||050103
|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)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 19, 2011|