NCT00104026

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2005

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2011

Completed
Last Updated

July 2, 2017

Status Verified

April 19, 2011

First QC Date

February 18, 2005

Last Update Submit

June 30, 2017

Conditions

Keywords

Periodontal DiseaseDilantinCyclosporinCalcium-Channel BlockersGeneticsHereditary Gingival FibromatosisHGFGingival OvergrowthGum Overgrowth

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 14529900BACKGROUND
  • Casetta 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: 9430129BACKGROUND
  • 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. doi: 10.1111/j.0303-6979.2004.00459.x.

    PMID: 15016038BACKGROUND

MeSH Terms

Conditions

Gingival OvergrowthPeriodontal DiseasesFibromatosis, Gingival, Hereditary

Condition Hierarchy (Ancestors)

Gingival DiseasesMouth DiseasesStomatognathic Diseases

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

Locations