Use of protective antigen of Bacillus anthracis as a model recombinant antigen to evaluate toll-like receptors 2, 3, 4, 7 and 9 agonists in mice using established functional antibody assays, antigen-specific antibody assays and cellular assays.

Toll-like receptor (TLR) agonists can act as immune stimulants alone or as part of alum or oil formulations. Humoral and cellular immune responses were utilized to assess quantitative and qualitative immune response enhancement by TLR agonists using recombinant protective antigen (rPA) of B. anthracis as a model antigen.

Management of painful temporomandibular disorders: Methods and overview of The National Dental Practice-Based Research Network prospective cohort study.

Background: Patients often seek consultation with dentists for temporomandibular disorders (TMDs). The objectives of this article were to describe the methods of a large prospective cohort study of painful TMD management, practitioners' and patients' characteristics, and practitioners' initial treatment recommendations conducted by The National Dental Practice-Based Research Network (the "network").

Methods: Participating dentists recruited into this study treated patients seeking treatment for painful TMDs.

Affinity purification of Car9-tagged proteins on silica-derivatized spin columns and 96-well plates.

The Car9 affinity tag is a dodecameric silica-binding peptide that can be fused to the N- and C-termini of proteins of interest to enable their rapid and inexpensive purification on underivatized silica in a process that typically relies on l-lysine as an eluent. Here, we show that silica paper spin columns and borosilicate multi-well plates used for plasmid DNA purification are suitable for recovering Car9-tagged proteins with high purity in a workflow compatible with high-throughput experiments. Spin columns typically yield 100 μg of biologically active material that can be recovered in minutes with low concentrations of lysine.

Comparative immunogenicity and efficacy of thermostable (lyophilized) and liquid formulation of anthrax vaccine candidate AV7909.

The anthrax vaccine candidate AV7909 is being developed as a next-generation vaccine for a post-exposure prophylaxis (PEP) indication against anthrax. AV7909 consists of the anthrax vaccine adsorbed (AVA) (Emergent BioSolutions Inc., Lansing, MI) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909.

Predictors of Long-Term Temporomandibular Disorder Pain Intensity: An 8-Year Cohort Study.

Aims: To investigate, in individuals with pain-related temporomandibular disorder (TMD), the association of long-term pain intensity with baseline health-related quality of life (HRQoL) and jaw functional limitation.

Methods: Of 513 cases with baseline pain-related TMD (masticatory muscle and/or temporomandibular joint [TMJ] pain), 273 were reevaluated after 8 years, and 258 of them had complete baseline data for Jaw Functional Limitation Scale (JFLS) scores and HRQoL measured by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the 12-item Short Form Health Survey and follow-up data for Characteristic Pain Intensity (CPI) from the Graded Chronic Pain Scale. Secondary analyses of existing data quantified the effects of primary (PCS, MCS) and secondary (JFLS) predictors on follow-up CPI by using multivariable linear regression.

Longitudinal Stability of Common TMJ Structural Disorders.

The longitudinal course of temporomandibular joint (TMJ) disc displacement (DD) and degenerative joint disease (DJD) has never been conclusively described with magnetic resonance imaging and computed tomography, respectively. This 8-y observational study's objective was to assess the longitudinal stability of DD and DJD among 401 subjects. The Validation Project provided baseline measures; follow-up was performed in the TMJ Impact Project.

Ligand-Modified Human Serum Albumin Nanoparticles for Enhanced Gene Delivery.

The development of nonviral gene delivery systems is a great challenge to enable safe gene therapy. In this study, ligand-modified nanoparticles based on human serum albumin (HSA) were developed and optimized for an efficient gene therapy. Different glutaraldehyde cross-linking degrees were investigated to optimize the HSA nanoparticles for gene delivery.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†.

Aims: The original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I diagnostic algorithms have been demonstrated to be reliable. However, the Validation Project determined that the RDC/TMD Axis I validity was below the target sensitivity of ≥ 0.70 and specificity of ≥ 0.

Effects of four treatment strategies for temporomandibular joint closed lock.

A previous randomized controlled trial (RCT) by Schiffman et al. (2007)(15) compared four treatments strategies for temporomandibular joint (TMJ) disc displacement without reduction with limited mouth opening (closed lock). In this parallel group RCT, 106 patients with magnetic resonance imaging (MRI)-confirmed TMJ closed lock were randomized between medical management, non-surgical rehabilitation, arthroscopic surgery, and arthroplasty.

Large-scale clinical endodontic research in the National Dental Practice-Based Research Network: study overview and methods.

Introduction: This article reports on the feasibility of conducting a large-scale endodontic prospective cohort study in The National Dental Practice-Based Research Network. This study was designed to measure pain and burden associated with initial orthograde root canal therapy (RCT) and to explore potential prognostic factors for pain outcomes. The main objectives of this first report in a series are to describe the project's feasibility and methods and the demographics of the sample obtained.

Transcutaneous immunization with Intercell's vaccine delivery system.

Transcutaneous immunization (TCI) has become an attractive alternate route of immunization due to increase understanding of the skin immune system and to recent technical innovations in skin patch delivery systems. Basic principles of TCI have been demonstrated in animal and human studies, covering a variety of bacterial, viral, and cancer diseases. At Intercell, we have advanced two major platforms of TCI: 1) a needle-free vaccine delivery patch (VDP) and 2) a vaccine enhancement patch (VEP).

The effect of catastrophizing and depression on chronic pain--a prospective cohort study of temporomandibular muscle and joint pain disorders.

Although most cases of temporomandibular muscle and joint disorders (TMJD) are mild and self-limiting, about 10% of TMJD patients develop severe disorders associated with chronic pain and disability. It has been suggested that depression and catastrophizing contributes to TMJD chronicity. This article assesses the effects of catastrophizing and depression on clinically significant TMJD pain (Graded Chronic Pain Scale [GCPS] II-IV).

Reliability and validity of Axis I of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) with proposed revisions.

  The research diagnostic criteria for temporomandibular disorders (RDC/TMD) have been employed internationally since 1992 for the study of temporomandibular muscle and joint disorders (TMD). This diagnostic protocol incorporates a dual system for assessment of TMD for Axis I physical diagnoses as well as Axis II psychological status and pain-related disability. Because the reliability and criterion validity of RDC/TMD had not yet been comprehensively characterised, the National Institute of Dental and Craniofacial Research funded in 2001 the most definitive research to date on the RDC/TMD as a U01 project entitled, 'Research Diagnostic Criteria: Reliability and Validity'.

Options for inactivation, adjuvant, and route of topical administration of a killed, unencapsulated pneumococcal whole-cell vaccine.

We previously reported that ethanol-killed cells of a noncapsulated strain of Streptococcus pneumoniae, given intranasally with cholera toxin as an adjuvant, protect rats against pneumonia and mice against colonization of the nasopharynx and middle ear by capsulated pneumococci of various serotypes. The acceleration of pneumococcal clearance from the nasopharynx in mice is CD4+ T cell-dependent and interleukin 17A (IL-17A) mediated and can be antibody independent. Here, anticipating human studies, we have demonstrated protection with a new vaccine strain expressing a nonhemolytic derivative of pneumolysin and grown in bovine-free culture medium.

Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders.

Aims: To evaluate the quality of methods used in randomized controlled trials (RCTs) of treatments for management of pain and dysfunction associated with temporomandibular muscle and joint disorders (TMJD) and to discuss the implications for future RCTs.

Methods: A systematic review was made of RCTs that were implemented from 1966 through March 2006, to evaluate six types of treatments for TMJD: orthopedic appliances, occlusal therapy, physical medicine modalities, pharmacologic therapy, cognitive-behavioral and psychological therapy, and temporomandibular joint surgery. A quality assessment of 210 published RCTs assessing the internal and external validity of these RCTs was conducted using the Consolidated Standards of Reporting Trials (CONSORT) criteria adapted to the methods of the studies.

The Research Diagnostic Criteria for Temporomandibular Disorders. VI: future directions.

The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project has provided the first comprehensive assessment of reliability and validity of the original Axis I and II. In addition, Axis I of the RDC/TMD was revised with estimates of reliability and validity. These findings are reported in the five preceding articles in this series.

The Research Diagnostic Criteria for Temporomandibular Disorders. V: methods used to establish and validate revised Axis I diagnostic algorithms.

Aims: To derive reliable and valid revised Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I diagnostic algorithms for clinical TMD diagnoses.

Methods: The multisite RDC/TMD Validation Project's dataset (614 TMD community and clinic cases, and 91 controls) was used to derive revised algorithms for Axis I TMD diagnoses. Validity of diagnostic algorithms was assessed relative to reference standards, the latter based on consensus diagnoses rendered by two TMD experts using criterion examination data, including temporomandibular joint imaging.

The Research Diagnostic Criteria For Temporomandibular Disorders. II: reliability of Axis I diagnoses and selected clinical measures.

Aims: The primary aim was to determine new estimates for the measurement reliability of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I diagnostic algorithms. A second aim was to present data on the reliability of key clinical measures of the diagnostic algorithms.

Methods: Kappa (k), computed by generalized estimate equation procedures, was selected as the primary estimate of interexaminer reliability.

The Research Diagnostic Criteria for Temporomandibular Disorders. I: overview and methodology for assessment of validity.

Aims: The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. The aim of this article is to provide an overview of the project's methodology, descriptive statistics, and data for the study participant sample. This article also details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses.