Viewing Study NCT00006300



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006300
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2000-09-27

Brief Title: Oral Manifestations of Aplastic Anemia
Sponsor: National Institute of Dental and Craniofacial Research NIDCR
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Oral Manifestations of Aplastic Anemia
Status: COMPLETED
Status Verified Date: 2002-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00-D-0113 None None None