Clinical Research Core Dental Screening Protocol
|First Received Date ICMJE||September 3, 2004|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||September 1, 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00090818 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Clinical Research Core Dental Screening Protocol|
|Official Title ICMJE||Clinical Research Core Dental Screening Protocol|
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:
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 patient's 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 patient's diagnosis, treatment, and clinical information. Disease-related or drug-related complications, or both, will be managed through collaboration with the patient's 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 and/or 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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Oral Mucosal Disease|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||October 28, 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients of any age, gender, and racial/ethnic group with oral diseases or systemic diseases with maxillofacial manifestations that are mission relevant for the Craniofacial Genetics Section, the Clinical Research Core and other branches located within the NIDCR.
Women of childbearing potential, or who are pregnant or lactating will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child. Only diagnosis without radiographs will be performed.
Patients with significant cognitive impairment.
Pregnant patients or lactating patients, if this status precludes proposed diagnostic procedures or therapies because of known untoward effects on mother and/or child.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00090818|
|Other Study ID Numbers ICMJE||040267, 04-D-0267|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Dental and Craniofacial Research (NIDCR)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 28, 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP