Standardised Tool for the Assessment of Bruxism.

OBJECTIVE: This paper aims to present and describe the Standardised Tool for the Assessment of Bruxism (STAB), an instrument that was developed to provide a multidimensional evaluation of bruxism status, comorbid conditions, aetiology and consequences. METHODS: The rationale for creating the tool and the road map that led to the selection of items included in the STAB has been discussed in previous publications. RESULTS: The tool consists of two axes, specifically dedicated to the evaluation of bruxism status and consequences (Axis A) and of bruxism risk and etiological factors and comorbid conditions (Axis B). The tool includes 14 domains, accounting for a total of 66 items. Axis A includes the self-reported information on bruxism status and possible consequences (subject-based report) together with the clinical (examiner report) and instrumental (technology report) assessment. The Subject-Based Assessment (SBA) includes domains on Sleep Bruxism (A1), Awake Bruxism (A2) and Patient's Complaints (A3), with information based on patients' self-report. The Clinically Based Assessment (CBA) includes domains on Joints and Muscles (A4), Intra- and Extra-Oral Tissues (A5) and Teeth and Restorations (A6), based on information collected by an examiner. The Instrumentally Based Assessment (IBA) includes domains on Sleep Bruxism (A7), Awake Bruxism (A8) and the use of Additional Instruments (A9), based on the information gathered with the use of technological devices. Axis B includes the self-reported information (subject-based report) on factors and conditions that may have an etiological or comorbid association with bruxism. It includes domains on Psychosocial Assessment (B1), Concurrent Sleep-related Conditions Assessment (B2), Concurrent Non-Sleep Conditions Assessment (B3), Prescribed Medications and Use of Substances Assessment (B4) and Additional Factors Assessment (B5). As a rule, whenever possible, existing instruments, either in full or partial form (i.e. specific subscales), are included. A user's guide for scoring the different items is also provided to ease administration. CONCLUSIONS: The instrument is now ready for on-field testing and further refinement. It can be anticipated that it will help in collecting data on bruxism in such a comprehensive way to have an impact on several clinical and research fields.

Challenges and best practices for digital unstructured data enrichment in health research: A systematic narrative review.

Digital data play an increasingly important role in advancing health research and care. However, most digital data in healthcare are in an unstructured and often not readily accessible format for research. Unstructured data are often found in a format that lacks standardization and needs significant preprocessing and feature extraction efforts. This poses challenges when combining such data with other data sources to enhance the existing knowledge base, which we refer to as digital unstructured data enrichment. Overcoming these methodological challenges requires significant resources and may limit the ability to fully leverage their potential for advancing health research and, ultimately, prevention, and patient care delivery. While prevalent challenges associated with unstructured data use in health research are widely reported across literature, a comprehensive interdisciplinary summary of such challenges and possible solutions to facilitate their use in combination with structured data sources is missing. In this study, we report findings from a systematic narrative review on the seven most prevalent challenge areas connected with the digital unstructured data enrichment in the fields of cardiology, neurology and mental health, along with possible solutions to address these challenges. Based on these findings, we developed a checklist that follows the standard data flow in health research studies. This checklist aims to provide initial systematic guidance to inform early planning and feasibility assessments for health research studies aiming combining unstructured data with existing data sources. Overall, the generality of reported unstructured data enrichment methods in the studies included in this review call for more systematic reporting of such methods to achieve greater reproducibility in future studies.

Efficiency of occlusal splint therapy on orofacial muscle pain reduction: a systematic review.

BACKGROUND: This systematic review aims to examine the existing original studies to determine the effectiveness of occlusal splints (OSs) in the management of orofacial myalgia and myofascial pain (MP) in comparison with no treatment or other interventions. MATERIALS AND METHODS: Based on the inclusion and exclusion criteria of this systematic review, randomized controlled trials were qualified, in which the effectiveness of occlusal splint therapy in the management of muscle pain was examined in comparison with no treatment or other interventions. This systematic review was conducted according to the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020. The authors searched three databases (PubMed, CINAHL (The Cumulative Index to Nursing and Allied Health Literature) and Scopus) for English publications published between January 1, 2010, and June 1, 2022. The last database search was carried out on June 4, 2022. Data were extracted from the included studies and assessed for risk of bias using the revised Cochrane risk-of-bias tool for randomized trials. RESULTS: Thirteen studies were identified for inclusion in this review. In total, 589 patients were diagnosed with orofacial muscle pain who underwent education and various forms of therapy including different types of OSs, light emitting diode therapy, acupuncture, low-level laser therapy, device-supported sensorimotor training, Kinesio Taping, myofunctional therapy, and physical therapy. All studies included demonstrated a high risk of bias. CONCLUSIONS: There is insufficient evidence regarding whether OS therapy in the treatment of orofacial myalgia and MP offers an advantage over other forms of interventions or no treatment. Further reliable clinical studies in this area are needed to improve the quality of research, which should be performed with larger groups of blinded respondents and controls. CLINICAL RELEVANCE: Due to the large-scale nature of orofacial muscle pain, it is assumed that each dental clinician will meet patients with orofacial muscle pain repeatedly in daily practice; hence, the review of the effectiveness of OSs in the management of orofacial myalgia and MP is necessary.

The development of the Standardised Tool for the Assessment of Bruxism (STAB): An international road map.

This paper summarises the background reasoning and work that led to the selection of the items included in the Standardised Tool for the Assessment of Bruxism (STAB), also introducing the list of items. The instrument is currently being tested for face validity and on-field comprehension. The underlying premise is that the different motor activities included in the bruxism spectrum (e.g. clenching vs. grinding, with or without teeth contact) potentially need to be discriminated from each other, based on their purportedly different aetiology, comorbidities and potential consequences. Focus should be on a valid impression of the activities' frequency, intensity and duration. The methods that can be used for the above purposes can be grouped into strategies that collect information from the patient's history (subject-based), from the clinical assessment performed by an examiner (clinically based) or from the use of instruments to measure certain outcomes (instrumentally based). The three strategies can apply to all aspects of bruxism (i.e. status, comorbid conditions, aetiology and consequences). The STAB will help gathering information on many aspects, factors and conditions that are currently poorly investigated in the field of bruxism. To this purpose, it is divided into two axes. Axis A includes the self-reported information on bruxism status and potential consequences (subject-based report) together with the clinical (examiner report) and instrumental assessment (technology report). Axis B includes the self-reported information (subject-based report) on factors and conditions that may have an etiological or comorbid role for bruxism. This comprehensive multidimensional assessment system will allow building predictive model for clinical and research purposes.

Mandibular advancement devices in obstructive sleep apnea: an updated review.

Obstructive sleep apnea (OSA) is the most prevalent sleep-disordered breathing in the adult population and if untreated remains a significant cause of morbidity and mortality. Continuous positive airway pressure (CPAP) therapy is still the gold standard treatment for OSA, but patient acceptance and adherence are often poor due to a multitude of factors, thereby compromising treatment success. Mandibular advancement devices (MADs) have been proposed not only as a first line therapy for symptomatic snoring patients, but also for those suffering from mild to moderate OSA, or those who refuse or do not tolerate CPAP. Yet, improved understanding of MAD regarding design, construction, and mechanisms of action is an important requirement to successfully implement MAD as a therapeutic tool. Therefore, the main focus of this paper is to focus on the general concepts and mechanisms of action of MAD, while highlighting important characteristics in the context of their use as a viable and effective treatment option for OSA patients.

Temporomandibular disorders in patients with polysomnographic diagnosis of sleep bruxism: a case-control study.

BACKGROUND: Temporomandibular disorders (TMD) is a collective term that refers to complaints of temporomandibular joint (TMJ) pain, fatigue and/or pain of the craniocervical muscles, limitation of movement of the mandible, and TMJ noises. Sleep bruxism (SB) is a disorder involving rhythmic (phasic) or non-rhythmic (tonic) masticatory muscle activity during sleep and is not a movement disorder or a sleep disorder in otherwise healthy individuals. The present study aimed to support or reject the null hypothesis that there is no association between SB and TMD. METHODS: The study population was recruited from patients who visited the Artmedica Clinic, Mossoro city, Rio Grande do Norte, Brazil. Patients who underwent polysomnography received information about the research and were invited to participate following the inclusion and exclusion criteria. The study sample consisted of 40 individuals with age ranging from 19 to 76 years. The subjects were administered the questionnaire of the European Academy of Craniomandibular Disorders (AEDC). Those who answered affirmatively to at least one question of the questionnaire were recommended to visit the primary researcher's dental clinic for examination; those who met the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) were evaluated, and their condition was classified into one or more subtypes of TMD. The subjects were divided into 4 groups according to the polysomnographic findings and the responses to the AEDC questionnaire. Of the 40 individuals who answered the AEDC questionnaire and underwent polysomnography, 28 presented with TMD symptoms. The data were expressed as simple frequency and percentage values using statistical software. Values of p < 0.05 were considered to be significant. RESULTS: The results showed that the frequency of TMD in individuals diagnosed to have SB was 46.4%. According to the DC/TMD of the 28 individuals, the most prevalent TMD subtype was local myalgia (85.7%). Of the total subjects, 32.5% had TMD and SB, 36.4% were males, and in the age range of 31 to 40 years (40%). CONCLUSION: In this study sample, there was no association between SB as currently defined and TMD, thus confirming previous findings on this topic.

Orofacial musculoskeletal pain: An evidence-based bio-psycho-social matrix model.

Pain is a multidimensional experience comprising sensory-discriminative, affective-motivational, and cognitive-evaluative dimensions. Clinical and research findings have demonstrated a complex interplay between social burdens, individual coping strategies, mood states, psychological disorders, sleep disturbances, masticatory muscle tone, and orofacial musculoskeletal pain. Accordingly, current classification systems for orofacial pain require psychosocial assessments to be an integral part of the multidimensional diagnostic process. Here, we review evidence on how psychosocial and biological factors may generate and perpetuate musculoskeletal orofacial pain. Specifically, we discuss studies investigating a putative causal relationship between stress, bruxism, and pain in the masticatory system. We present findings that attribute brain structures various roles in modulating pain perception and pain-related behavior. We also examine studies investigating how the nervous and immune system on cellular and molecular levels may account for orofacial nociceptive signaling. Furthermore, we review evidence pointing towards associations between orofacial musculoskeletal pain and neuroendocrine imbalances, sleep disturbances, and alterations of the circadian timing system. We conclude with several proposals that may help to alleviate orofacial pain in the future.

In-vivo kinematic assessment of alloplastic temporomandibular joint replacements by means of helical axis: A cohort study with historical control.

Alloplastic total temporomandibular joint replacement (TJR) is a surgical procedure used to restore normal mandibular function when conservative therapies fail. The instantaneous helical axis (HA), is a mathematical model used to visualize globally rigid body kinematics. It can be applied to mandibular motion for quantification of movement patterns and irregularities. Aim of this study was to analyze HA pathways in subjects with unilateral and bilateral TJR and compare them to a control group. An optoelectronic system was employed to track mouth opening/closing cycles (n = 3) of 15 patients (7 operated unilaterally, 8 bilaterally, 11 F, aged 24-72) and 12 controls (6 F, aged 23-40). HA position in space was determined for 30 equally-distributed steps of the observed movement. Total mandibular rotation around HA (Φtot) and total translation along HA (Ttot) were determined. Angles between HA and the anatomical coordinate system of the head (θx, θy, θz); global fluctuation of HA spatial orientation (θe), distance between condylar center (CP) and HA (dCP) and its projections on the axes (xdCP, ydCP, zdCP) were calculated. Overall, Φtot was larger in controls than in bilaterally operated subjects (p = 0.002, p = 0.003) and θz was larger in unilaterally operated subjects than in controls (p = 0.004) and bilaterally operated subjects (p = 0.002, p = 0.024). During opening, θe¯ was smaller in controls than in unilaterally operated subjects (p = 0.01). The distance dCP was smaller for alloplastic joints than for controls (p < 0.01 overall). In conclusion, mandibular HA pathways in patients with TJR differ significantly from controls in terms of spatial location and variability.

Resolution of fibromyalgia by controlling obstructive sleep apnea with a mandibular advancement device.

Fibromyalgia (FM) is a chronic, often disabling disorder characterized by multisite pain along with sleep problems and fatigue. Pain and sleep exhibit a reciprocal relationship. When FM and obstructive sleep apnea/hypopnea (OSA) co-exist, treatment options include continuous positive airway pressure or mandibular advancement device. We present a patient experiencing fibromyalgia and OSA whose symptoms vanished wearing a Mandibular Advancement Device (MAD) during sleep. To our knowledge, this is the first documented case of FM symptom resolution by MAD treatment.

The Pain-to-Well-Being Relationship in Patients Experiencing Chronic Orofacial Pain.

Introduction: Orofacial pain features may negatively influence a person's well-being and vice versa. Some aspects of well-being can be measured with axis II instruments that assess patients' psychosocial and behavioral status. The aim of this study was to investigate associations between pain features and psychosocial variables as indicators of well-being. Materials and Methods: Seven hundred ninety-nine anonymized datasets collected using the Web-based Interdisciplinary Symptom Evaluation (WISE) of patients reporting to the Interdisciplinary Orofacial Pain Unit, University of Zurich, between March 19, 2017 and May 19, 2019, were analyzed. Pain features including intensity, number of locations, impact, and duration were evaluated. Psychometric measures assessed pain-related catastrophizing and disability, illness perception, distress, anxiety, depression, injustice experience, dysmorphic concerns, and insomnia. Results: Most patients were between 30 and 59 years old (58.3%), female (69.8%), working (66.0%), and experienced pain for more than 6 months (68.5%). Pain intensities were higher in women than men and higher in disabled than working patients. Scores indicating elevated stress and depression were also observed in disabled patients. The sample prevalence rates of clinically relevant axis II instrument scores were as follows: Graded Chronic Pain Scale for the Head (GCPS-H), 27%; Patient Health Questionnaire 4 (PHQ4), 21%; PHQ9, 21%; Pain Catastrophizing Scale (PCS), 20%; General Anxiety Disorder 7 (GAD7), 15%; Insomnia Severity Index (ISI), 15%; Injustice Experience Questionnaire (IEQ), 14%; GCPS for the Body (GCPS-B), 13%; PHQ for Stress (PHQstr), 6%; and Dysmorphic Concern Questionnaire (DCQ), 2%. Noteworthy results of correlation analysis of the clinically relevant axis II scores and pain measures were as follows: the PHQstr had moderate associations (0.34-0.43) with the sum of pain intensity at rest and during function, number of pain locations, and typical pain intensity. The IEQ scores were moderately associated with typical pain intensity at 0.39. The DCQ scores were moderately associated with pain extension at 0.41. Conclusions: Moderate correlations of certain pain and well-being measures were found in patients reporting clinically relevant stress, injustice experience, and dysmorphic concern, all of which reflect impaired well-being. PHQ4 is suitable for routine distress screening in the clinical setting.

Ultrasound Imaging of Injections in Masseter Muscle without Contrast Agent Using Strain Elastography and a Novel B-Mode Spatiotemporal Filter.

Botulinum toxin type A (BTX-A) injections in masseter muscle can alleviate muscle tightness and aching pain caused by idiopathic masticatory myalgia, a subform of the myofascial pain syndrome. Yet the injection procedure (number, amount) is currently empirical. In this ex vivo study, we determined the feasibility of using contrast-free ultrasound imaging to visualize the short-term injectate propagation. Ultrasound annotations of BTX-A injectate spread in N = 12 porcine masseter muscles were compared with the histopathology of the excised masseter. BTX-A presence was automatically detected in the ultrasound cine by: compensating tissue motion and deformation during injection with a novel spatiotemporal filtering (SF) algorithm, and by imaging tissue swelling strains with strain elastography (SE). BTX-A injectate introduced 6.5% (standard deviation = 5.0%) echogenicity contrast and 13.9% (standard deviation = 3.7%) tissue swelling strain. Muscle fasciae were a border for BTX-A distribution. The SF algorithm achieved significantly higher noise rejection (contrast-to-noise ratio = 4.63) than SE (2.56, p = 0.01), and state-of-the-art 2-D digital image correlation (1.81, p < 0.001) and direct image subtraction (1.29, p < 0.001) methods. Histopathology agreed well with ultrasound (Dice coefficient = 0.48), with deviations mainly explained by the three-dimensional inhomogeneous distribution of BTX-A. Preliminary in vivo patient results indicated that SF and SE discard artifactual BTX-A detection outside the injection region. The proposed methods contribute to objectivize ultrasound-guided injections, with additional applications, for instance, to monitor injectate spread of local anesthetics.

[Integrative treatment concept for chronic orofacial pain and temporomandibular disorders]. / Integrativer Behandlungsansatz bei chronischen Kiefer- und Gesichtsbeschwerden.

The interdisciplinary Orofacial Pain Unit at the Center of Dental Medicine of the University of Zurich celebrates its 15th anniversary. This article outlines the evidence-based integrative treatment concept with a focus on psychosocial aspects of pain. We exemplify how the evaluation and treatment by a pain psychologist complements the dental therapy. For example, self-management techniques can assist in reducing apprehension, worries and fears, which are often associated with an increased tone of the masticatory muscles. Manifestations include clenching and grinding of teeth, orofacial pain, and other less specific symptoms such as tinnitus. The clinical relevance is illustrated by selected case studies from routine clinical practice.

Towards a Standardized Tool for the Assessment of Bruxism (STAB)-Overview and general remarks of a multidimensional bruxism evaluation system.

The aim of the present paper was to give an overview of the general project and to present the macrostructure of a comprehensive multidimensional toolkit for the assessment of bruxism, viz. a bruxism evaluation system. This is a necessary intermediate step that will be detailed in a successive extended publication and will ultimately lead to the definition of a Standardized Tool for the Assessment of Bruxism (STAB) as the final product. Two invitation-only workshops were held during the 2018 and 2019 General Session & Exhibition of the International Association for Dental Research (IADR) meetings. Participants of the IADR closed meetings were split into two groups, to put the basis for a multidimensional evaluation system composed of two main axes: an evaluation Axis A with three assessment domains (ie subject-based, clinically based and instrumentally based assessment) and an aetiological/risk factors Axis B assessing different groups of factors and conditions (ie psychosocial assessment; concurrent sleep and non-sleep conditions; drug and substance use or abuse; and additional factors). The work of the two groups that led to the identification of different domains for assessment is summarised in this manuscript, along with a road map for future researches. Such an approach will allow clinicians and researchers to modulate evaluation of bruxism patients with a comprehensive look at the clinical impact of the different bruxism activities and aetiologies. The ultimate goal of this multidimensional system is to facilitate the refinement of decision-making algorithms in the clinical setting.

Evaluating the Effects of Acupuncture Using a Dental Pain Model in Healthy Subjects - A Randomized, Cross-Over Trial.

Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (ß = -.708, P = .002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain.

[Temporomandibular disorders - a biopsychosocial perspective]. / Kiefergelenkbeschwerden ­ eine biopsychosoziale Umschau.

Temporomandibular disorders - a biopsychosocial perspective Abstract. Clinicians encountering patients complaining of jaw joint symptoms need to see and understand the patients' somatic complaint in the context of possible biographic, psychological and social burdens and to select the appropriate therapeutic options accordingly.

Measuring anger in patients experiencing chronic pain - A systematic review.

Anger is prevalent in chronic pain and has been associated with pain perception, disability, behavior and treatment outcome. Objectives were (1) to survey in the context of chronic pain the application (and omission) of validated anger self-report instruments, (2) to discuss the instruments found in the context of emotion theories and (3) to identify a possible instrument preference. A systematic search of textbooks and review articles was first performed on validated instruments designed to measure the cognitive, the motivational and the subjective feeling component of anger. Thereafter, a systematic review aimed at finding chronic pain studies from 2005 to 2019 reporting on these instruments. Textbooks and reviews listed 16 validated self-report anger measurement instruments. 28 papers applying four of these were identified and two new instruments were additionally detected. The State-Trait Anger Expression (STAXI) and its precursors were most commonly used. Studies on chronic low back pain patients prevailed. In conclusion, anger in chronic pain patients is reliably measurable at low cost with self-report tools. The STAXI-II qualifies best for this purpose based on its extensive validation history. The majority of instruments lack sufficient theoretical and psychometric adequacy. A more detailed exploration of the cognitive anger component in chronic pain patients in future research is recommended.

Insomnia in Patients Seeking Care at an Orofacial Pain Unit.

Introduction: Orofacial pain and dysfunction include a broad range of disturbances among which pain and insomnia are some of the most common complaints. Sleep strengthens physiological and psychological resilience and is an absolute requirement for health. Insomnia is a common symptom or sleep disorder, yet data on its prevalence is sparse. Here we extracted data from the insomnia severity index which was part of the web-based interdisciplinary symptom evaluation (WISE) tool given to a large sample of patients seeking care at an orofacial pain unit for analyzing insomnia prevalence in this clinical population. Material and methods: Anonymized data were available from 952 patients who consulted the Orofacial Pain Unit at the Center of Dental Medicine, University of Zurich, Zurich, Switzerland between January 2017 and December 2018. Prevalence data for insomnia stratified by gender and 10 age groups (decades) were calculated. The distribution of four insomnia severity grades was determined, also stratified by age and gender. Results: 952 patients (290 men: 30.5%) with a mean age of 44.8 ± 17.4 years completed a WISE. Three hundred and fifty-two (37.0%) patients with a mean age of 45.8 ± 16.7 years positively responded to a screening question for insomnia and/or hypersomnia. Insomnia was severe in women from the 2nd to 8th decade, ranging from 4.3% (3rd decade) to 14.5% (6th decade), and moderately severe from the 2nd to 9th decade, ranging from 18.8% (6th decade) to 27.8% (2nd decade). In men, severe insomnia was present from the 3rd to 7th decade, ranging from 2.3% (7th decade) to 4.4% (4th decade) and moderately severe insomnia from the 3rd to 7th decade, ranging from 4.6% (7th decade) to 12.2% (5th decade). Conclusions: This is the first study reporting on insomnia in a large sample of patients seeking care at an orofacial pain unit. One in three patients reported some form of sleep disturbances, which for almost half of them was moderate to severe insomnia. The gender ratio was almost equal throughout adulthood, yet younger and older women were more frequently affected and experienced higher insomnia severity than men.

Dentin hypersensitivity monitored by cold air quantitative sensory testing.

BACKGROUND: Quantification of dentin hypersensitivity (DH) is challenging and requires standardised, graded stimulation by natural-like stimuli. OBJECTIVE: The present study aimed at identifying DH subjects and longitudinally monitoring their pain thresholds by cold air quantitative sensory testing (QST). METHODS: Subject recruitment started with an online DH questionnaire. Respondents were screened by dental air stimulation. Sensitising and habituating subjects were excluded. A recently developed stimulation device was employed for cold air QST. Single tooth DH was verified by applying an equi-intense stimulus to a control tooth. Descriptive statistics were applied for subject characteristics. Mean values were calculated for the stimulation parameters temperature and air flow. Reliability of temperatures for detecting pain and for evoking moderate pain over multiple time points within a 3-week period was analysed by two-way random single- and average-measure intra-class correlation coefficients. RESULTS: A total of 353 persons completed the online DH questionnaire of which 117 were screened. Forty-four passed the screening, yet 15 were excluded for various reasons. Twenty-nine subjects were monitored by QST across 3 weeks. Results revealed a high intra-individual stability of the temperature inducing moderate to strong pain intensity (MPI) (single-measure ICC of TMPI 0.83, P < 0.001). Mean TMPI was -13.69°C, yet it highly varied among the 29 subjects (SD ± 10.04°C). CONCLUSIONS: Using a novel approach, namely dental QST based on cold air stimuli, we present evidence for temporally stable DH perceptions over a 3-week period. The method fulfils international guideline requirements and is recommendable for obtaining valid results when testing various interventions for DH management.

Temporomandibular joint magnetic resonance imaging findings in adolescents with anterior disk displacement compared to those with juvenile idiopathic arthritis.

BACKGROUND: Deformation of the mandibular condyle can be associated with anterior disk displacement (ADD) or involvement of the temporomandibular joint (TMJ) by juvenile idiopathic arthritis (JIA). Diagnostic differentiation is critical for proper management. OBJECTIVES: To compare morphology and inflammation between TMJs with ADD and JIA. METHODS: Retrospective assessment of contrast-enhanced TMJ MRI in 18 adolescents (15 female, mean age 15.1 ± 1.9 years) with ADD and age- and gender-matched patients with JIA. Articular disk findings, inflammatory signs and osseous morphology were compared. RESULTS: In the ADD group, 31 of 36 disks were displaced. In total, 28 of 31 displaced disks showed thickening of the bilaminar zone. In JIA patients, the disks were mainly flattened (19/36), centrally perforated (12/36) and/or anteriorly displaced (2/36). In total, 19 of 31 TMJs with ADD showed various degrees of inflammation, with joint effusion, synovial thickening and joint enhancement not significantly different from JIA patients. Osseous deformity was present in 27 of 31 TMJs with ADD, with frequent erosions in both groups (ADD 25/31; JIA 32/36, P = 0.55) but lower grades of condylar and temporal bone flattening than in JIA (P ≤ 0.001). Glenoid fossa depth was preserved in 28 of 31 joints with ADD and decreased in 26 of 36 joints with JIA (P < 0.0001). Mandibular ramus height was decreased in both groups. CONCLUSION: In adolescents, inflammatory signs are common MRI findings in symptomatic TMJs with ADD and thus should not be considered diagnostic for JIA involvement. In this cohort, both entities had high rates of condylar deformity, while TMJs with ADD showed a better-preserved and often normal shape of the glenoid fossa.

Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience.

BACKGROUND: This study aimed to describe recruitment challenges encountered during a phase IIa study of vixotrigine, a state and use-dependent Nav1.7 channel blocker, in individuals with trigeminal neuralgia. METHODS: This was an international, multicenter, placebo-controlled, randomized withdrawal study that included a 7-day run-in period, a 21-day open-label phase, and a 28-day double-blind phase in which patients (planned n = 30) were randomized to vixotrigine or placebo. Before recruitment, all antiepileptic drugs had to be stopped, except for gabapentin or pregabalin. After the trial, patients returned to their original medications. Patient recruitment was expanded beyond the original five planned (core) centers in order to meet target enrollment (total recruiting sites N = 25). Core sites contributed data related to patient identification for study participation (prescreening data). Data related to screening failures and study withdrawal were also analyzed using descriptive statistics. RESULTS: Approximately half (322/636; 50.6%) of the patients who were prescreened at core sites were considered eligible for the study and 56/322 (17.4%) were screened. Of those considered eligible, 26/322 (8.1%) enrolled in the study and 6/322 (1.9%) completed the study. In total, 125 patients were screened across all study sites and 67/125 (53.6%) were enrolled. At prescreening, reasons for noneligibility varied by site and were most commonly diagnosis change (78/314; 24.8%), age > 80 years (75/314; 23.9%), language/distance/mobility (61/314; 19.4%), and noncardiac medical problems (53/314; 16.9%). At screening, frequently cited reasons for noneligibility included failure based on electrocardiogram, insufficient pain, and diagnosis change. CONCLUSIONS: Factors contributing to recruitment challenges encountered in this study included diagnosis changes, anxiety over treatment changes, and issues relating to distance, language, and mobility. Wherever possible, future studies should be designed to address these challenges. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01540630 . EudraCT, 2010-023963-16. 07 Aug 2015.