Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104026
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-02-18
Brief Title:
Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
Status:
COMPLETED
Status Verified Date:
2011-04-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-D-0103 | None | None | None |