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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006300
Other study ID # 000113
Secondary ID 00-D-0113
Status Completed
Phase N/A
First received September 27, 2000
Last updated March 3, 2008
Start date April 2000
Est. completion date April 2002

Study information

Verified date April 2002
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date April 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

N/A


Locations

Country Name City State
United States National Institute of Dental And Craniofacial Research (NIDCR) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Jones JE, Coates TD, Poland C. Dental management of idiopathic aplastic anemia: report of a case. Pediatr Dent. 1981 Sep;3(3):267-70. — View 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. — View Citation

Young NS. Acquired aplastic anemia. JAMA. 1999 Jul 21;282(3):271-8. Review. Erratum in: JAMA 2000 Jan 5;283(1):57. — View Citation

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