NCT00006300

Brief Summary

The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral complications in patients with aplastic anemia; 2) to evaluate if oral problems in these patients can predict their response to treatment; and 3) to review complications of dental treatment in these patients in order to establish treatment guidelines. This study will be performed through a review of medical charts of 79 patients with aplastic anemia and 67 patients with schizophrenia who were treated at the National Institutes of Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a control population. Demographic, clinical and radiographic information will be collected for all patients. Additional data collected only for aplastic anemia patients will include medical therapy, disease duration, blood cell counts, oral problems that developed during treatment and treatment response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2000

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

April 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2000

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2002

First QC Date

September 27, 2000

Last Update Submit

March 3, 2008

Conditions

Aplastic Anemia

Keywords

ImmunosuppressionTreatment RecommendationsPancytopeniaSchizophreniaInpatient Population

Eligibility Criteria

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

You may qualify if:

  • Cases: All aplastic anemia patients evaluated at the NIH dental clinic for consultation between 1993-1999.
  • Controls: All schizophrenic patients evaluated at the NIH dental clinic for consultation between 1993-1999.

You may not qualify if:

  • Patients without the diagnosis of aplastic anemia for cases or schizophrenia for the controls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Luker J, Scully C, Oakhill A. Gingival swelling as a manifestation of aplastic anemia. Oral Surg Oral Med Oral Pathol. 1991 Jan;71(1):55-6. doi: 10.1016/0030-4220(91)90521-d.

    PMID: 1994323BACKGROUND

  • Jones JE, Coates TD, Poland C. Dental management of idiopathic aplastic anemia: report of a case. Pediatr Dent. 1981 Sep;3(3):267-70. No abstract available.

    PMID: 6461852BACKGROUND

  • Young NS. Acquired aplastic anemia. JAMA. 1999 Jul 21;282(3):271-8. doi: 10.1001/jama.282.3.271. No abstract available.

    PMID: 10422997BACKGROUND

MeSH Terms

Conditions

Anemia, AplasticPancytopeniaSchizophrenia

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow DiseasesCytopeniaSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 27, 2000

First Posted

September 28, 2000

Study Start

April 1, 2000

Study Completion

April 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-04

Locations

US(1)