Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for OLP. We report on the efficacy and safety of a novel mucoadhesive clobetasol patch (Rivelin® -CLO) for the treatment of OLP. METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life. RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-µg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%). CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.

Self-collected unstimulated saliva, oral swab, and nasopharyngeal swab specimens in the detection of SARS-CoV-2.

OBJECTIVES: The presence of SARS-CoV-2 virus in the saliva of patients infected with COVID-19 has been confirmed by several studies. However, the use of saliva for the diagnosis of COVID-19 remains limited, because of the discrepancies in the results, which might be due to using different saliva sampling methods. The purpose of this study was to compare the consistency of SARS-CoV-2 detection using two different saliva sampling methods (oral swab and unstimulated saliva) to that of the standard nasopharyngeal swab. METHODS: Fifty-five subjects were recruited from a pool of COVID-19 inpatient at the Hospital Israelita Albert Einstein (HIAE), Brazil. Nasopharyngeal swab, oral swab, and self-collected unstimulated saliva samples were examined for SARS-CoV-2 using RT-PCR. RESULTS: Self-collected unstimulated saliva demonstrated 87.3% agreement in the detection of SARS-CoV-2 virus as compared with the nasopharyngeal swab, while oral swab displayed 65.9% agreement when compared to nasopharyngeal swab and 73% when compared to self-collected unstimulated saliva. CONCLUSION: Unstimulated self-collected saliva samples have shown a higher agreement with the nasopharyngeal swab samples for SARS-COV-2 detection than that obtained when using oral swab samples. CLINICAL RELEVANCE: This study compares the accuracy of COVID-19 test using different saliva sampling methods to that of nasopharyngeal swab. Given the need for a simple self-applied test that can be performed at home, our findings support the efficacy of self-collected unstimulated saliva samples in the diagnosis of SARS-CoV-2 infection, alleviating the demands for swab supplies, personal protective equipment, and healthcare personnel.

Identification of potential genomic biomarkers for Sjögren's syndrome using data pooling of gene expression microarrays.

Sjögren's syndrome (SS) is an autoimmune disease characterized by lymphocytic infiltration and destruction of salivary and lacrimal glands. The diagnosis of SS can be challenging due to lack of a specific test for the disease. The purpose of this study is to examine the accuracy of using gene expression profile for diagnosis of SS. We identified 9 publically available datasets that included gene expression data from saliva and salivary gland biopsy samples of 52 patients with SS and 51 controls. Out of these datasets, we compiled and pooled data from three datasets that included 37 and 29 samples from SS patients and healthy controls, respectively, which were designated as "training set." Then, we performed cross-listing in a group of independent gene expression datasets from patients with SS to identify consensus gene list of differentially expressed genes. We performed Linear Discriminant Analysis (LDA) to quantify the accuracy of discriminating genes to predict SS in both the "training set" and an independent group of datasets that was designated as "test set." We identified 55 genes as potential classifier genes to differentiate SS from healthy controls. An LDA by leave-one-out cross-validation method identified 19 genes (EPSTI1, IFI44, IFI44L, IFIT1, IFIT2, IFIT3, MX1, OAS1, SAMD9L, PSMB9, STAT1, HERC5, EV12B, CD53, SELL, HLA-DQA1, PTPRC, B2M, and TAP2) with highest classification accuracy rate (95.7 %). Moreover, we validated our results by reproducing the same gene expression profile as a discriminatory test in the "test set," which included data from salivary gland samples of 15 patients with SS and 22 controls with 94.6 % accuracy. We propose that gene expression profile in the saliva or salivary glands could represent a promising simple and reproducible diagnostic biomarker for SS.

Sarcoidosis and Sjögren's syndrome: clinical and salivary evaluation.

BACKGROUND: Sarcoidosis and Sjögren's syndrome are two different diseases; however, when affecting the salivary glands, both diseases exhibit similar clinical signs and symptoms, which often complicates the diagnosis. The purpose of this study was to investigate the possibility of using salivary electrophoresis to differentiate between the two diseases. METHODS: Saliva was collected from patients with sarcoidosis and patients with Sjögren's syndrome. Salivary flow rate, total protein, and electrophoretic profiles were examined. RESULTS: Mean salivary flow rate was 0.41 ± 0.07 ml/min/gland vs. 0.43 ± 0.07 ml/min/gland; total salivary protein was 130.0 ± 29.2 mg% vs. 104.0 ± 8.8 mg% for sarcoidosis vs. Sjögren's syndrome, respectively. No differences were observed in salivary flow rate, total salivary protein, or electrophoretic profile between patients with sarcoidosis and patients with Sjögren's syndrome (P = 0.768, 0.718, and 1.000, respectively). CONCLUSIONS: Salivary protein electrophoresis does not appear to be useful to differentiate between sarcoidosis and Sjögren's syndrome.

Laser Assisted Non-surgical Periodontal Therapy: A Double Blind, Randomized Clinical Trial.

The objective of this study was to examine potential benefits of using laser therapy for secular decontamination in conjunction with scaling and root planing in the treatment of chronic periodontitis. The study was performed on 173 teeth in 14 patients in a split-mouth design, one side received scaling and root planing followed by laser therapy using a carbon dioxide (CO2) laser with an ablative handpiece (test group); the contralateral side received scaling and root planing without laser (control group). Clinical and laboratory parameters were evaluated prior to treatment and at 3 and 6 months following therapy; clinical measurements were performed by two blinded examiners. The clinical parameters included measurement of gingival recession (REC), bleeding on probing (BOP), clinical attachment level (CAL), pocket depth (PD), furcation involvement (FUR), and tooth mobility (MOB). Laboratory testing to determine the levels of periodontal pathogens was performed using PCR techniques. The results of the study revealed statistically significant differences in clinical and laboratory parameters at 3 and 6 months after therapy for both test and control groups, but no significant difference was observed between the two groups. However, sites receiving laser therapy tended to show a greater decrease in probing depths, gain in clinical attachment level, and reduced bacterial levels. In conclusion, the overall results of the study suggest a potential benefit of using laser therapy in conjunction with scaling and root planing for the treatment of chronic periodontitis.

Experimental chairside test for the rapid diagnosis of oropharyngeal candidiasis.

Oral infection with Candida fungal species is very common. Oral candidiasis is usually diagnosed by clinical appearance because no chairside diagnostic methods are available. In contrast, a rapid latex agglutination (RLA) test has proven useful for in-office diagnosis of vulvovaginal candidiasis. This study was undertaken to determine if the RLA technique might be used to provide a quick chairside test for oral candidiasis. Twenty-five patients participated in the study, including 21 patients with clinical evidence suggestive of oral candidiasis serving as the experimental group and 4 patients with apparent good oral health serving as controls. The presence of oral candidiasis was evaluated using RLA, fungal culturing, and cytology. RLA testing was consistent with established diagnostic tests in patients with oral candidiasis. However, RLA false positive results were noted, and the test is highly technique-sensitive and subjective. The technique is worthy of further study to determine its ultimate value in the diagnosis of oral candidiasis.

The Role of Occlusion in the Dental Implant and Peri-implant Condition: A Review.

Dental implants have become a widely used dental treatment approach. It is important to identify factors that can be detrimental to dental implants and the peri-implant complex. There is controversy regarding whether occlusion plays a role in the implant and peri-implant condition. The present study aims to review the scientific literature regarding this topic. Animal and human studies, and previous reviews on the topic are included and presented. There is a wide heterogeneity among study designs. Several articles demonstrated that occlusion and occlusion overload could detrimentally affect the peri-implant condition, while other articles did not support these results. More studies are needed to help understand the mechanisms by which occlusion might play a role in the peri-implant condition.

Clinical practice guidelines for oral management of Sjögren disease: Dental caries prevention.

BACKGROUND: Salivary dysfunction in Sjögren disease can lead to serious and costly oral health complications. Clinical practice guidelines for caries prevention in Sjögren disease were developed to improve quality and consistency of care. METHODS: A national panel of experts devised clinical questions in a Population, Intervention, Comparison, Outcomes format and included use of fluoride, salivary stimulants, antimicrobial agents, and nonfluoride remineralizing agents. The panel conducted a systematic search of the literature according to pre-established parameters. At least 2 members extracted the data, and the panel rated the strength of the recommendations by using a variation of grading of recommendations, assessment, development, and evaluation. After a Delphi consensus panel was conducted, the experts finalized the recommendations, with a minimum of 75% agreement required. RESULTS: Final recommendations for patients with Sjögren disease with dry mouth were as follows: topical fluoride should be used in all patients (strong); although no study results link improved salivary flow to caries prevention, the oral health community generally accepts that increasing saliva may contribute to decreased caries incidence, so increasing saliva through gustatory, masticatory, or pharmaceutical stimulation may be considered (weak); chlorhexidine administered as varnish, gel, or rinse may be considered (weak); and nonfluoride remineralizing agents may be considered as an adjunct therapy (moderate). CONCLUSIONS AND PRACTICAL IMPLICATIONS: The incidence of caries in patients with Sjögren disease can be reduced with the use of topical fluoride and other preventive strategies.

Xerostomia secondary to Sjögren's syndrome in the elderly: recognition and management.

Xerostomia is a common symptom in the elderly population. Studies have suggested that the underlying cause of approximately 40% of xerostomia in the elderly is Sjögren's syndrome. Although it is highly prevalent among middle-aged individuals, elderly patients account for up to 20% of Sjögren's syndrome cases. Sjögren's syndrome is a multisystem exocrinopathy characterised by dry mouth and dry eyes with wide-ranging extraglandular involvement. The exocrine manifestations of Sjögren's syndrome affect the mouth, eyes, nose, ears, skin, vagina and the entire respiratory and gastrointestinal systems. The nonexocrine involvement may include the joints, thyroid gland, liver, kidneys and the musculoskeletal, vascular and central nervous systems. Currently, the mechanism(s) of development and progression of Sjögren's syndrome is/are not clear. Inflammation and lymphocytic infiltration of the exocrine glands is a classical feature of Sjögren's syndrome. During the progression of the disease, the acinar cells of the exocrine glands are replaced by fibrosis, rendering the glands nonfunctional. Sjögren's syndrome remains one of the most underdiagnosed conditions, particularly in the elderly population, because the cardinal sicca symptoms, which are the hallmark of the disease, are frequently attributed to aging and/or medications, which consequently delays the diagnosis. This delay in diagnosis imposes significant physical, psychological and economic burdens on elderly patients. The diagnosis of Sjögren's syndrome requires evaluation of both the exocrine and nonexocrine components of the disease. Management of Sjögren's syndrome requires collaboration by the primary-care physician, rheumatologist, ophthalmologist and dentist. This article reviews current understanding of the clinical manifestations, diagnosis and treatment of Sjögren's syndrome with special emphasis on the oral component of the disease.

Preliminary evaluation of salivary pellicle on nickel-chromium alloy in vivo.

OBJECTIVE: The composition of the salivary interface (pellicle) between dental restorations and oral mucosa may be critical to the biocompatibility of the restoration. The purpose of this study was to examine the molecular composition of the salivary pellicle on nickel-chromium alloy in vivo. METHOD AND MATERIALS: The molecular components of nickel-chromium pellicle was examined with sodium dodecyl sulfate-polyacrylamide gel electrophoresis and Western blot analyses. RESULTS: Only limited numbers of salivary proteins were found to participate in the formation of nickel-chromium pellicle in vivo. Salivary amylase and secretory immunoglobulin A were among the proteins identified in the pellicle. CONCLUSION: In vivo, nickel-chromium pellicle consists of selectively adsorbed salivary proteins. Because both salivary amylase and secretory immunoglobulin A are antimicrobial proteins, it is possible that they play a role in modulating the microbial flora on the nickel-chromium prosthesis.

Managing xerostomia and salivary gland hypofunction: executive summary of a report from the American Dental Association Council on Scientific Affairs.

BACKGROUND AND OVERVIEW: Xerostomia, also known as "dry mouth," is a common but frequently overlooked condition that is typically associated with salivary gland hypofunction, which is the objective measurement of reduced salivary flow. Patients with dry mouth exhibit symptoms of variable severity that are commonly attributed to medication use, chronic disease and medical treatment, such as radiotherapy to the head and neck region. Chronic xerostomia significantly increases the risk of experiencing dental caries, demineralization, tooth sensitivity, candidiasis and other oral diseases that may affect quality of life negatively. This article presents a multidisciplinary approach to the clinical management of xerostomia, consistent with the findings of published systematic reviews on this key clinical issue. CONCLUSIONS AND PRACTICE IMPLICATIONS: Initial evaluation of patients with dry mouth should include a detailed health history to facilitate early detection and identify underlying causes. Comprehensive evaluation, diagnostic testing and periodic assessment of salivary flow, followed by corrective actions, may help prevent significant oral disease. A systematic approach to xerostomia management can facilitate interdisciplinary patient care, including collaboration with physicians regarding systemic conditions and medication use. Comprehensive management of xerostomia and hyposalivation should emphasize patient education and lifestyle modifications. It also should focus on various palliative and preventive measures, including pharmacological treatment with salivary stimulants, topical fluoride interventions and the use of sugar-free chewing gum to relieve dry-mouth symptoms and improve the patient's quality of life.

Sjögren's syndrome: diagnosis and management.

This article reviews current understanding of the clinical manifestations, diagnosis and treatment of Sjögren's syndrome. Sjögren's syndrome is a chronic inflammatory disorder of the exocrine glands with multiple nonexocrine features. It is found predominantly in middle-aged women but exists throughout the population. The diagnosis of Sjögren's syndrome can be challenging because the cardinal sicca symptoms may be subclinical or attributed to other causes, such as medications or aging. Differential diagnosis of Sjögren's syndrome can be confounded by the multiple exocrine manifestations in the mouth, eyes, ears, nose, skin, vagina, and respiratory and gastrointestinal tracts, as well as seemingly unrelated nonexocrine involvement in the thyroid, liver, kidneys and the musculoskeletal, vascular and nervous systems. This article concludes that early diagnosis of Sjögren's syndrome is crucial to prevent and/or minimize potentially life-threatening complications. Periodic follow-up of patients' status and collaboration between the primary-care physician and the rheumatologist, dentist, ophthalmologist and other specialists are indispensable.

Comparison of salivary calmodulin binding proteins in Sjögren's syndrome and healthy individuals.

BACKGROUND: Reduction in salivary secretion is the hallmark of Sjögren's syndrome (SS). Calmodulin (CaM) and calmodulin binding proteins (CaMBPs) play a key role in the secretory process of saliva. Recent studies have suggested that SS-B, an autoantibody associated with SS, is a CaMBP. This finding suggests that CaMBP may contribute to the loss of saliva in SS. To better understand the role(s) of these proteins in SS, the purpose of this study was to compare salivary CaMBPs in Sjögren's patients and controls. METHODS: Saliva samples were collected from 20 patients and 20 age-, race-, and gender-matched controls. CaM overlay was used to identify CaMBPs in saliva of patients and controls. RESULTS: Higher number of salivary CaMBPs was observed among patients than controls. CONCLUSIONS: The increased number of salivary CaMBPs in SS may suggest a potential role for these proteins in the pathogenesis of the disease.

Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations.

Several therapeutic agents have been investigated for the treatment of oral lichen planus (OLP). Among these are corticosteroids, retinoids, cyclosporine, and phototherapy, in addition to other treatment modalities. A systematic review of clinical trials showed that particularly topical corticosteroids are often effective in the management of symptomatic OLP lichen planus. Systemic corticosteroids should be only considered for severe widespread OLP and for lichen planus involving other mucocutaneous sites. Because of the ongoing controversy in the literature about the possible premalignant character of OLP, periodic follow-up is recommended. There is a spectrum of oral lichen planus-like ("lichenoid") lesions that may confuse the differential diagnosis. These include lichenoid contact lesions, lichenoid drug reactions and lichenoid lesions of graft-versus-host disease. In regard to the approach to oral lichenoid contact lesions the value of patch testing remains controversial. Confirmation of the diagnosis of an oral lichenoid drug reaction may be difficult, since empiric withdrawal of the suspected drug and/or its substitution by an alternative agent may be complicated. Oral lichenoid lesions of graft-versus-host disease (OLL-GVHD) are recognized to have an association with malignancy. Local therapy for these lesions rests in topical agents, predominantly corticosteroids.

Management of oral epithelial dysplasia: a review.

One of the goals of the fourth meeting of The World Workshop on Oral Medicine (WWOM IV) included a review of the pathophysiology and future directions for the clinical management of patients with oral epithelial dysplasia, excluding the lips and oropharynx. In the pathophysiology review of dysplasia since WWOM III (1998-2006), a wide range of molecular changes associated with progression of dysplasia to squamous cell carcinoma were found. These include loss of heterozygosity, dysregulation of apoptosis, aberrant DNA expression, and altered expression of numerous tissue markers. Based on the literature search, no single molecular pathway has been identified as the primary factor in progression of dysplasia to squamous cell carcinoma. A systematic review of medical (i.e., nonsurgical) management strategies for the treatment of dysplastic lesions has shown promising results in short-term resolution of dysplasia in the small number of studies that met eligibility criteria for review. However, because of the limited periods of follow-up reported in these studies, it remains unclear as whether resolution of dysplasia would actually be a long-term benefit of these interventions. This question is particularly germane when it is considered in the context of prevention of future development of squamous cell carcinoma. Because of the lack of randomized controlled trials that have shown effectiveness in the prevention of malignant transformation, no recommendations can be provided for specific surgical interventions of dysplastic oral lesions either.

Assessment of SS-A and SS-B in parotid saliva of patients with Sjögren's syndrome.

BACKGROUND: The purpose of this study was to compare the sensitivity of parotid saliva to that of serum in detecting anti-SSA/Ro and anti-SSB/La autoantibodies in patients with Sjögren's syndrome. METHODS: Forty patients and 20 controls participated in the study; all patients met the 1993 European Community criteria for the diagnosis of Sjögren's syndrome. Healthy controls were age- and sex-matched individuals with no signs or symptoms of Sjögren's syndrome. Serum and saliva samples were evaluated using AffiniTech SSA/Ro and SSB/La antibodies kits (AffiniTech, Ltd. Bentonville, AR, USA). The results were also compared with serological status of SS-A and SS-B as reported by an independent clinical laboratory. RESULTS: Serum was significantly more sensitive than saliva in detecting SSA/Ro and SSB/La antibodies (P = 0.001). There was high agreement between the results with the AffiniTech kits and the independent laboratory (kappa = 0.80; P < 0.001). However, there was poor agreement between saliva and serum results (kappa = 0.174; P = 0.168). CONCLUSIONS: The overall results appear to support that serum analysis is effective method for evaluating the presence of SS-A and SS-B autoantibodies.