Oral Manifestations of Aplastic Anemia

Aplastic Anemia Clinical Trial

Official title:

Oral Manifestations of Aplastic Anemia

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
• 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia
• Oral Manifestations

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