Oral Manifestations of Aplastic Anemia

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00006300
Collaborator
(none)
146
1
24
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Official Title:
    Oral Manifestations of Aplastic Anemia
    Study Start Date :
    Apr 1, 2000
    Study Completion Date :
    Apr 1, 2002

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 National Institute of Dental And Craniofacial Research (NIDCR) Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute of Dental and Craniofacial Research (NIDCR)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00006300
      Other Study ID Numbers:
      • 000113
      • 00-D-0113
      First Posted:
      Sep 28, 2000
      Last Update Posted:
      Mar 4, 2008
      Last Verified:
      Apr 1, 2002

      Study Results

      No Results Posted as of Mar 4, 2008