Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090818
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-09-03
Brief Title:
Clinical Research Core Dental Screening Protocol
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Research Core Dental Screening Protocol
Status:
COMPLETED
Status Verified Date:
2010-10-28
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:
This study will screen patients for eligibility in studies sponsored by the Craniofacial Genetics Section HCGS the Clinical Research Core CRC and other branches located within the National Institute of Dental and Craniofacial Research NIDCR It will also evaluate patients with diseases or abnormalities of the oral cavity or craniofacial complex or both for future protocol development HCGS and CRC study the natural history of oral diseases and systemic diseases that are manifested in the maxillofacial region-the upper jaw and face Among the diseases are lichen planus systemic lupus erythematosus and premalignant oral leukoplakia Researchers also study certain acquired diseases and genetic diseases Because many of the diseases of the maxillofacial region are poorly defined the evaluation and characterization of patients with such diseases are goals of investigation
Patients of any age gender and racial and ethnic group who have oral diseases or systemic diseases of the upper jaw and face may be eligible for the study Women of childbearing potential or who are pregnant or lactating may be eligible they would undergo procedures and tests or receive medications posing a minimal risk to the fetus or child
Participants will undergo the following procedures
Complete medical history and physical examination including a thorough examination of the head and neck detailed examination of the teeth and gums may or may not be necessary
Tests of blood urine stool tests for pregnancy and HIV when needed and tests for cultures fungi bacteria and parasites
Sampling of blood and oral tissues for diagnosis treatment response and disease progression
Electrocardiogram x-ray and imaging procedures including imaging of the face
Biopsies may be performed as needed for diagnosis and to guide therapy The type number location and frequency of biopsies depend on several factors including the nature of the disease being evaluated Local anesthesia is typically used unless there are contraindications Some biopsies are done with disposable 2 to 3 mm round sharp metal punches Larger excisions with the use of an appropriate blade may be necessary for proper evaluation of a patients condition or complete removal of something that is abnormal The risks and discomfort associated with any of the interventions include mild pain bleeding and infection there may be temporary facial paralysis bruising and allergic reactions
Supportive care will be given as needed according to the patients diagnosis treatment and clinical information Disease-related or drug-related complications or both will be managed through collaboration with the patients referring physician
Patients of any age gender and racial and ethnic group who have oral diseases or systemic diseases of the upper jaw and face may be eligible for the study Women of childbearing potential or who are pregnant or lactating may be eligible they would undergo procedures and tests or receive medications posing a minimal risk to the fetus or child
Participants will undergo the following procedures
Complete medical history and physical examination including a thorough examination of the head and neck detailed examination of the teeth and gums may or may not be necessary
Tests of blood urine stool tests for pregnancy and HIV when needed and tests for cultures fungi bacteria and parasites
Sampling of blood and oral tissues for diagnosis treatment response and disease progression
Electrocardiogram x-ray and imaging procedures including imaging of the face
Biopsies may be performed as needed for diagnosis and to guide therapy The type number location and frequency of biopsies depend on several factors including the nature of the disease being evaluated Local anesthesia is typically used unless there are contraindications Some biopsies are done with disposable 2 to 3 mm round sharp metal punches Larger excisions with the use of an appropriate blade may be necessary for proper evaluation of a patients condition or complete removal of something that is abnormal The risks and discomfort associated with any of the interventions include mild pain bleeding and infection there may be temporary facial paralysis bruising and allergic reactions
Supportive care will be given as needed according to the patients diagnosis treatment and clinical information Disease-related or drug-related complications or both will be managed through collaboration with the patients referring physician
Detailed Description:
The purpose of this clinical research protocol is twofold 1 to screen patients for protocol eligibility for those sponsored primarily by the Craniofacial Genetics Section the Clinical Research Core and other Branches located within the National Institute of Dental and Craniofacial Research NIDCR as appropriate and 2 to evaluate patients with diseases or abnormalities of the oral cavity andor craniofacial complex for future protocol development Patients enrolled in this protocol will be evaluated and treated according to standard procedures and therapeutic modalities No procedures will be done for research only Standard or experimental biochemical genetic and proteomic tests may be conducted on tissue or blood samples collected for diagnosis Eligible patients will be referred to appropriate NIDCR clinical research protocols for further protocol-driven diagnostic workup and therapy
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 |
|---|---|---|---|
| 04-D-0267 | None | None | None |