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Oral Manifestations of Aplastic Anemia
This study has been completed.
First Received: September 27, 2000   Last Updated: March 3, 2008   History of Changes
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006300
  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

MedlinePlus related topics: Anemia Schizophrenia
U.S. FDA Resources
Study Type: Observational
Official Title: Oral Manifestations of Aplastic Anemia

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006300

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

Publications:
Study ID Numbers: 000113, 00-D-0113
Study First Received: September 27, 2000
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00006300     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Mouth Diseases
Schizophrenia
Signs and Symptoms
Oral Manifestations
Aplastic Anemia
Hematologic Diseases
Anemia, Aplastic
Anemia
Pancytopenia
Stomatognathic Diseases
Bone Marrow Diseases

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

ClinicalTrials.gov processed this record on May 06, 2009