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Oral Manifestations of Aplastic Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006300
First Posted: September 28, 2000
Last Update Posted: March 4, 2008
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Aplastic Anemia

Study Type: Observational
Official Title: Oral Manifestations of Aplastic Anemia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 146
Study Start Date: April 2000
Estimated Study Completion Date: April 2002
Detailed Description:
The prevalence, risk factors and significance of oral manifestations in aplastic anemia have not been well characterized. Thus, in the present study, through a retrospective chart review, we document the prevalence of oral complications in AA patients and the risks for oral manifestations in a case-control study. Schizophrenic patients represent controls. Information includes the following; demographic, clinical and radiographic information for cases and controls. Additional data collection for only AA patients includes prior medical therapy, CBC and differential, disease duration, new oral manifestations during AA treatment and medical treatment response. We determine if systemic clinical features of AA predict oral manifestations, and if oral manifestations predict treatment outcomes for AA patients. Finally complications following dental treatment are compiled and reviewed to establish initial treatment guidelines for these patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006300


Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006300     History of Changes
Other Study ID Numbers: 000113
00-D-0113
First Submitted: September 27, 2000
First Posted: September 28, 2000
Last Update Posted: March 4, 2008
Last Verified: April 2002

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunosuppression
Treatment Recommendations
Pancytopenia
Schizophrenia
Inpatient Population

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Oral Manifestations
Hematologic Diseases
Bone Marrow Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms