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Oral Manifestations of Aplastic Anemia

Primary Purpose

Aplastic Anemia

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Aplastic Anemia focused on measuring Immunosuppression, Treatment Recommendations, Pancytopenia, Schizophrenia, Inpatient Population

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Dental And Craniofacial Research (NIDCR)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 27, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00006300
Brief Title
Oral Manifestations of Aplastic Anemia
Official Title
Oral Manifestations of Aplastic Anemia
Study Type
Observational

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aplastic Anemia
Keywords
Immunosuppression, Treatment Recommendations, Pancytopenia, Schizophrenia, Inpatient Population

7. Study Design

Enrollment
146 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Dental And Craniofacial Research (NIDCR)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1994323
Citation
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.
Results Reference
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PubMed Identifier
6461852
Citation
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.
Results Reference
background
PubMed Identifier
10422997
Citation
Young NS. Acquired aplastic anemia. JAMA. 1999 Jul 21;282(3):271-8. doi: 10.1001/jama.282.3.271. No abstract available. Erratum In: JAMA 2000 Jan 5;283(1):57.
Results Reference
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Oral Manifestations of Aplastic Anemia

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