Long-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: A randomised sham-controlled feasibility study (LEONIDAS-1).

BACKGROUND: Effective treatments for dry mouth of Sjogren's syndrome are limited and hampered by adverse effects. The aim of LEONIDAS-1 was to explore the feasibility of salivary electrostimulation in individuals with primary Sjogren's syndrome, as well as parameters required to inform the design of a future phase III trial. METHODS: Multicentre, parallel-group, double-blind, randomised sham-controlled trial in two UK centres. Participants were randomised (1:1, computer-generated) to active or sham electrostimulation. The feasibility outcomes included screening/eligibility ratio, consent, and recruitment and drop-out rates. Preliminary efficacy outcome included dry mouth visual analogue scale, Xerostomia Inventory, the EULAR Sjögren's syndrome patient reported index-Q1, and unstimulated sialometry. RESULTS: Forty-two individuals were screened, of whom 30 (71.4%) met the eligibility criteria. All eligible individuals consented to recruitment. Out of the 30 randomised participants (active n = 15, sham n = 15), 4 dropped out and 26 (13 vs. 13) completed all study visits as per protocol. Recruitment rate was 2.73 participants/month. At 6-month post-randomisation the difference in mean reduction in visual analogue scale, xerostomia inventory and EULAR Sjögren's syndrome patient reported index-Q1 scores between groups were 0.36 (95% CI: -0.84, 1.56), 3.31 (0.43, 6.18), and 0.23 (-1.17, 1.63), respectively; unstimulated salivary flow increased by a mean of 0.98 mL/15 min, all in favour of the active group. No adverse events were reported. CONCLUSION: LEONIDAS-1 results support progression to a phase III definitive randomised controlled trial of salivary electrostimulation in individuals with Sjogren's syndrome. Xerostomia inventory could be considered the primary patient-centred outcome measure and the corresponding observed treatment effect could inform the sample size of a future trial.

Patient and clinician perspectives of information needs concerning oral epithelial dysplasia.

OBJECTIVES: Individuals diagnosed with a chronic oral disease that increase the risk of mouth cancer, such as oral epithelial dysplasia (OED), require appropriate knowledge to make informed decisions. The present study aimed to assess whether patient information needs of a group of patients concerning dysplasia were met and to what degree clinicians agree with patients on 'important' topics. SUBJECTS AND METHODS: This represented secondary analyses of a cross-sectional study to assess the information needs of 86 patients diagnosed with dysplasia compared with those of 77 clinicians using the validated OED Information Needs Questionnaire. Descriptive, concordance and regression analyses were performed for the collected data. RESULTS: The mean and median total scores for all items in the amount of information received subscale were 2.33 and 2.44, indicating overall unmet needs concerning dysplasia. Clinicians were generally able to predict topics of greatest importance to patients, although their scores were mainly lower than those of patients (k = 0.06). There was a higher agreement between patients (k = 0.25) than clinicians (k = 0.09). CONCLUSION: Clinicians are encouraged to assess a patient's information needs to ensure tailored and patient-centred communication concerning OED during all clinical consultations.

Psychosocial impacts of oral epithelial dysplasia.

BACKGROUND: The psychosocial impact of receiving the diagnosis of oral epithelial dysplasia, which presents up to 3.5% increased annual risk of mouth cancer, remains unknown. Using validated instruments, the present study aimed to investigate the prevalence and existing correlations between anxiety, depression and dental anxiety symptoms and burden on oral health-related quality of life. METHODS: A clinical cohort of 82 patients with oral dysplasia was asked to complete the Hospital Anxiety and Depression Scale, the Modified Dental Anxiety Scale and the shortened version of the Oral Health Impact Profile. Spearman's correlation coefficient and regression analyses were performed. RESULTS: The participants' scores were in keeping with the presence of anxiety, depression and emotional distress symptoms in 30%, 16% and 26%, respectively. However, 69% experienced anxiety related to procedures that may be required as part of long-term management of oral dysplasia (e.g. local anaesthetic injection). The oral health-related quality of life scores showed 41.5% reporting a recent daily problem due to their oral or dental health. Significant correlations [p >0.05] were found among and between all of the used instruments. Being a female with oral dysplasia also predicted increased odds of indicating higher anxiety and dental anxiety scores than males [p >0.05]. CONCLUSION: Oral dysplasia can adversely impact on the psychosocial well-being of affected persons. Establishing a causal relationship between the measured variables may, however, be challenging and would need further longitudinal studies.

Pentoxifylline, tocopherol, and sequestrectomy are effective for the management of advanced osteoradionecrosis of the jaws-a case series.

BACKGROUND: The aim of the present study was to evaluate the efficacy of pentoxifylline and tocopherol for the management of osteoradionecrosis of the jaws. METHODS: Twenty-five patients diagnosed with osteoradionecrosis of the jaws treated with pentoxifylline 400 mg + tocopherol 400 mg three times daily (tid) were evaluated. Clinical records and image tests were reviewed. All patients were previously submitted to head and neck radiation therapy and presented with a clinical and radiographic diagnosis of osteoradionecrosis of the jaws. RESULTS: Following therapy with pentoxifylline and tocopherol, 76% (19/25) of the patients showed complete mucosal healing, in which 47.3% (9/19) did not undergo sequestrectomy. From this particular group, 77.7% (7/9) were in stage I and 33.3% (3/9) used the protocol for up to 3 months. Among those who underwent to sequestrectomy, complete mucosal healing was observed in 52.7% (10/19). Among these, 60% (6/10) were in stage I and 100% of the patients were using the protocol for more than 3 months. In all other patients, partial healing of the mucosa was observed since they presented advanced disease. These represented 24% of the sample (6/25), 66.6% (4/6) were in stage III, and 60% (4/6) used the protocol for over 6 months. CONCLUSION: Pentoxifylline and tocopherol may provide effective management of osteoradionecrosis of the jaws, and the association with sequestrectomy may avoid major surgical procedures.

Validity and reliability of the Mouth Handicap of Systemic Sclerosis questionnaire in a UK population.

BACKGROUND: The objective of this study was to explore the psychometric properties of the Mouth Handicap in Systemic Sclerosis (MHISS) specifically exploring aspects of validity and reliability of MHISS in UK SSc patients. METHODS: A total of 150 questionnaires were distributed in this study at the Oral Medicine Department of UCLHT Eastman Dental Hospital, the Outpatient Rheumatology Clinic of the Royal Free Hospital and Scleroderma Family Day. Participants were asked to complete three questionnaires (SF-36, OHIP-14 and MHISS) along with a pro forma of demographic and disease-specific questions. Both convergent validity and internal consistency reliability were examined. The convergent validity was assessed by Spearman's correlation coefficient, and internal consistency reliability was assessed by Cronbach's alpha. RESULTS: Of the 150 questionnaires distributed to participants, 68 respondents were included. With regard to construct validity, a low to moderate degree of convergent validity was found between MHISS total score and all SF-36 subscales. However, the total MHISS score was highly correlated to all OHIP subscales. CONCLUSION: MHISS questionnaire is a self-administered patient-reported outcome measure that assesses the mouth disability in SSc patients. However, improving the global and oral health of SSc patients is important as there is no cure for the disease; thus, instruments that record the impact of the condition and indicate the effect of treatment on the lives of patients are of paramount importance. Current results demonstrate good preliminary psychometric properties (validity and reliability) in a UK population with further exploration of psychometric properties with an emphasis on interpretability required.

Challenges of the interface of oral medicine and periodontology: Some lessons for the future?

This final chapter provides a commentary of what might be learned from this series of articles in relation to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions and argues that future classifications should expand sections on nondental plaque-induced disease that will further patient care, education and research in periodontology, and allied subjects.

Measurement properties of patient-reported outcome measures in radiotherapy-induced trismus.

Trismus or lockjaw is the reduction in mouth opening. Radiotherapy-induced trismus occurs when the masticatory muscles are within range of radiation treating head and neck cancer, resulting in muscular fibrosis and trismus. We aim to assess the measurement properties of available validated patient-reported outcome measures relevant to radiotherapy-induced trismus in head and neck cancer patients. Systematic electronic searches were performed in MEDLINE and EMBASE databases to identify studies validating radiotherapy-induced trismus with patient-reported outcome measures up to January 2018. Two reviewers independently rated the methodological quality of identified validation studies, using the consensus-based standards for the selection of health status measurement instrument (COSMIN) checklist. The level of evidence for measurement properties was then summarised based upon pre-defined criteria. Only one of the 280 retrieved studies were deemed fit for inclusion. The Gothenburg Trismus Questionnaire was assessed and found to have a good methodological quality of measurement properties except for reliability, which was poor. There was a moderate level of evidence supporting internal consistency, content validity, structural validity and hypothesis testing. The evidence for test-retest reliability remains unknown in the population of interest. The Gothenburg Trismus Questionnaire is the only patient-reported outcome measure in the field of showing some good measurement properties, and it may therefore represent a useful instrument for the assessment of radiotherapy-induced trismus in head and neck cancer patients. However, further validation studies are needed especially with respect to the reliability, measurement error and the responsiveness of this instrument.

Interventions for dry mouth and hyposalivation in Sjögren's syndrome: A systematic review and meta-analysis.

OBJECTIVES: Systematic review with meta-analysis of interventions for dry mouth symptoms and hyposalivation of Sjögren's syndrome (SS). MATERIALS AND METHODS: We searched MEDLINE, Cochrane Central and EMBASE up to February 2018 for randomized trials of interventions for dry mouth and hyposalivation of SS. The primary outcome was the mean change in xerostomia symptoms. The secondary outcomes included changes in salivary flow and quality of life. We used the Cochrane risk of bias tool for individual studies and the GRADE method to summarize the quality of evidence across studies for the included outcomes. RESULTS: Thirty-six studies (3,274 patients) were included in the systematic review. Results from the meta-analyses showed high-quality evidence that pilocarpine was superior to placebo in reducing dry mouth symptoms. We found moderate quality of evidence that pilocarpine, rituximab and interferon-alpha were more effective than placebo in increasing salivary flow, with the relevant effect size being large for pilocarpine, and notably smaller for rituximab and interferon-alpha. CONCLUSION: Clinicians should be very confident in the beneficial effects of pilocarpine upon dry mouth symptoms of SS and moderately confident that pilocarpine, rituximab and interferon-alpha can have beneficial effects upon salivary flow. Adverse events are common. The use of other treatment modalities cannot be supported on the basis of current evidence.

Oral features of systemic sclerosis: A case-control study.

OBJECTIVE: The aim of this study was to evaluate the orofacial parameters of systemic sclerosis (SSc) and its related systemic features. SUBJECTS AND METHODS: A descriptive case-control study was performed from November 2015 to October 2016. Ninety-three individuals were included and divided into SSc group (n = 50) and healthy controls (C, n = 43). RESULTS: Systemic sclerosis individuals were mostly women (43/50, 86%), with a mean age of 46 years (±11.6 years). Telangiectasia (42/50, 84%) and reduced mouth opening (35/50, 70%) were the most frequent orofacial findings. The periodontitis frequency was much higher in SSc individuals than in healthy controls (90.7% × 48.83%; p < .001). In addition, SSc individuals presented a distinctive pattern of periodontitis, with low probing pocket depth (2 ± 0.65 mm × 2 ± 0.24; p < .001), higher gingival recession (4 ± 2.13 × 0.14 ± 0,22; p < .001), higher periodontal attachment loss (6 ± 1.34 mm × 2 ± 0.43, p < .001), and lower gingival bleeding index values (7.05 ± 7.25 × 21.57 ± 15.66; p < .001). CONCLUSIONS: Orofacial manifestations were common in SSc and included a unique pattern of periodontal manifestation, characterized by lower gingival bleeding index, higher periodontal attachment loss, and low probing depth.

Candida species in patients with oral dysesthesia: A comparison of carriage among oral disease states.

OBJECTIVES: Oral dysesthesia (burning mouth syndrome) is characterized by a burning-like sensation of the oral mucosa. The etiology of this disorder is still unknown, however, associations with oral fungal carriage have been proposed and applied clinically. The aim of the this study was to compare oral Candida carriage in patients with oral dysesthesia with Candida carriage in patients with other commonly diagnosed oral diseases to clarify the relationship between Candida and oral dysesthesia. SUBJECTS AND METHODS: In total, 441 patients in total including 79 patients diagnosed with oral dysesthesia were included in this study. A retrospective analysis of mycological investigations undertaken in patients with clinically diagnosed oral dysesthesia compared with other oral conditions was undertaken. RESULTS: Oral carriage of Candida was found in 63.3% (50 of 79) of patients with oral dysesthesia. The frequency of carriage and oral load of Candida were not significantly increased in patients with oral dysesthesia relative to the other conditions assessed. Patients with clinical signs of fungal infection or xerostomia presented with increased carriage of Candida. CONCLUSION: There is no association between oral dysesthesia and the presence or load of oral Candida.

Validity and reliability of the Chronic Oral Mucosal Diseases Questionnaire in a UK population.

OBJECTIVE: The objective of this study was to investigate the validity and reliability of a the Chronic Oral Mucosal Diseases Questionnaire in a UK population METHODS: Two hundred patients with chronic oral mucosal disease (oral lichen planus, recurrent aphthous stomatitis, mucous membrane pemphigoid, pemphigus vulgaris) were enrolled in this study from the Oral Medicine Department of University College London Hospitals Trust (UCLHT) Eastman Dental Hospital. Individuals were interviewed using Oral Health Impact Profile (OHIP-14), Visual Analogue Scale (VAS) and Chronic Oral Mucosal Diseases Questionnaire (COMDQ), and the construct validity and internal reliability were examined. RESULTS: Of the 200 study participants, 100 respondents had oral lichen planus, 42 had recurrent aphthous stomatitis and 58 had vesiculobullous conditions (mucous membrane pemphigoid or pemphigus vulgaris). With regard to construct validity, a moderate to good degree of convergent validity was found between OHIP-14 and VAS and most subscales and the total COMDQ score except the patient support subscale of COMDQ (0.21-0.37). CONCLUSION: COMDQ is a valid and reliable patient-reported outcome measure for patients with chronic oral mucosal diseases in a UK population. It can be considered a valuable instrument in both clinical practice and in oral medicine research.

Oral health and elite sport performance.

While the research base is limited, studies have consistently reported poor oral health in elite athletes since the first report from the 1968 Olympic Games. The finding is consistent both across selected samples attending dental clinics at major competitions and more representative sampling of teams and has led to calls from the International Olympic Committee for more accurate data on oral health. Poor oral health is an important issue directly as it can cause pain, negative effects on appearance and psychosocial effects on confidence and quality of life and may have long-term consequences for treatment burden. Self-reported evidence also suggests an impact on training and performance of athletes. There are many potential challenges to the oral health of athletes including nutritional, oral dehydration, exercise-induced immune suppression, lack of awareness, negative health behaviours and lack of prioritisation. However, in theory, oral diseases are preventable by simple interventions with good evidence of efficacy. The consensus statement aims to raise awareness of the issues of oral health in elite sport and recommends strategies for prevention and health promotion in addition to future research strategies.

Th1 and Th2 polymorphisms in Sjögren's syndrome and rheumatoid arthritis.

BACKGROUND: Sjogren's syndrome is characterized by T-cell infiltration of exocrine glands leading to parenchymal destruction and impaired glandular function. This process is orchestrated by cytokines, whose secretion can be regulated by genetic polymorphisms. MATERIALS AND METHODS: The aim of this study was to investigate the influence of interleukin-6 -174G/C, interleukin-10 -1082G/A, tumor necrosis factor-α -308G/A, interferon-γ +874A/T gene polymorphisms in (RA) and secondary Sjögren's syndrome (sSS). A study sample that comprised of 138 Brazilian patients was divided into three groups: RA (n = 66), sSS (n = 20), and healthy controls - C (n = 52). Patients were subjected to Schirmer's test, unstimulated salivary flow rate, biopsy of minor salivary glands, and serological tests for diagnosing SS. Genomic DNA was obtained from saliva samples and submitted to genotyping. The association between genotypes/alelle frequency and SS susceptibility was tested, as well as their association with clinical features of SS. RESULTS: Tumor necrosis factorα (TNFα)-308GA polymorphisms differed significantly between AR, SS, and C patients (P = 0.008). IL-6 overall G carriers and TNFα A carriers had a higher risk of presenting SS (P = 0.021). IL-6 polymorphism distribution was also distinctive regarding lymphocytic infiltration at the minor salivary glands (P = 0.026) and Schirmer's test (P = 0.035). CONCLUSION: These results suggest that IL-6 -174GC and TNFα-308GA gene polymorphisms are associated with susceptibility to SS. Additionally, IL-6 polymorphism could influence lymphocytic infiltration of salivary glands and diminish lachrymal gland function.

Exploring the Acceptability of HIV Testing in the UK Dental Setting: A Qualitative Study.

HIV point of care testing (POCT) is a common approach to expanding testing into non-specialised settings. Dental services have untapped potential to screen for health conditions including HIV. However, the perspectives of UK dental patients, dental professionals, and people with HIV are unknown. Ten focus groups were undertaken with dental patients, professionals, and people with HIV. The Framework method was used to analyse the qualitative data. Six themes were generated from the focus group data. The themes explored perceptions of HIV, the purpose, appropriateness, and acceptability of HIV testing in dental settings, and new processes that would need to be established in order to successfully implement point of care HIV testing in UK dental settings. Training needs were identified including communication skills and updates to current knowledge about HIV. HIV testing in dental settings is generally acceptable to dental patients, dental professionals, and PWH. However, of concern were logistical challenges and the risk of patients surprised at being offered an HIV test during a visit to the dentist. Nonetheless, the public health benefits of the intervention were well understood, i.e., early detection of HIV and initiation of treatment to improve health outcomes. Dental teams were able to generate novel solutions that could help to overcome contextual and logistical challenges to implementing HIV testing in dental settings.

Point of care HIV testing in dental settings in high-income countries: A mixed-methods systematic review.

OBJECTIVES: Expanding HIV testing beyond specialized services has been a key strategic approach to eliminating the transmission of HIV. In recent years, dental settings have been identified as offering an opportunity for delivering point of care HIV testing (POCT) interventions. Intervention components and implementation strategies have varied across studies and there is uncertainty about the prevalence of undiagnosed HIV in the dental patient population. Therefore, this systematic review aimed to synthesize the HIV testing outcomes of intervention studies, identify the core components of POCT interventions implemented in dental settings; and understand the barriers and facilitators to intervention implementation. METHODS: A mixed-methods systematic review was undertaken. Two authors reviewed abstracts and full papers for inclusion and appraised the studies using the Mixed Methods Appraisal Tool. A convergent integrated mixed methods study design underpinned the synthesis. Outcomes were presented using descriptive statistics. Intervention components were mapped to the Template for Intervention Description and Replication (TIDieR) checklist. Barriers and facilitators were described using a narrative thematic analysis. RESULTS: POCT was offered to 22 146 dental patients, 62.5% accepted POCT. Intervention studies that reported higher uptake of testing utilized a dedicated dental or researcher staff member to provide testing, integrated testing and provided results within the routine dental appointment and adopted a provider-initiated universal approach to offering testing. Six themes emerged that were pertinent to the barriers and facilitators to HIV testing in dental setting. CONCLUSIONS: POCT uptake in dental settings was comparable with other non-specialized health settings. Key to the operationalization of the intervention were perceptions about its value and relevance to the dental patient population, attitudes toward the intervention, logistical barriers to its implementation, the risk of HIV testing stigma to the patient-practitioner relationship and maximising the fit of the intervention within the constraints of the dental setting.

Salivary Electrostimulation in the Treatment of Radiation Therapy-Induced Xerostomia (LEONIDAS-2): A Multicenter, Randomized, Double-Masked, Sham-Controlled, Phase 3 Trial.

PURPOSE: Radiation therapy-induced xerostomia significantly affects quality of life in head and neck cancer survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms. METHODS AND MATERIALS: This multicenter, double-masked, randomized, sham-controlled clinical trial assessed the long-term effects of a commercially available intraoral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow, and improving quality of life in individuals with radiation therapy-induced xerostomia. Using a computer-generated randomization list, participants were assigned (1:1) to an active intraoral custom-made removable electrostimulating device or a sham device to be used for 12 months. The primary outcome was the proportion of patients reporting a 30% improvement on the xerostomia visual analog scale at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and visual analog scale) and quality-of-life questionnaires (EORTC QLQ-H&N35, OH-QoL16, and SF-36). RESULTS: As per protocol, 86 participants were recruited. Intention-to-treat analyses showed no statistical evidence of a difference between the study groups with respect to the primary outcome or for any of the secondary clinical or quality-of-life outcomes. Exploratory analyses showed a statistically significant difference in the changes over time of the dry mouth subscale score of the EORTC QLQ-H&N35 in favor of the active intervention. CONCLUSIONS: LEONIDAS-2 did not meet the primary and secondary outcomes.

The Effects of Antimicrobial Mouthwashes on Systemic Disease: What Is the Evidence?

The potential association between antimicrobial mouthwash use and systemic health has gained attention in recent years with reports highlighting how some common systemic conditions are influenced by the use of different types of mouthwashes. In this context, links between mouthwash use and cardiovascular disease, diabetes mellitus, oral cancer, Alzheimer's disease, and preeclampsia have been proposed, albeit with limited levels of evidence. Chlorhexidine mouthwash in particular has been the most widely studied agent while available data on other types of over-the-counter mouthwashes are generally scarce. Furthermore, there is currently no evidence-based recommendations on the appropriate use of mouthwashes during pregnancy. This article will present the current evidence on the association between mouthwash use and the aforementioned conditions with emphasis on the mechanisms that may underlie such an association.

Human herpesvirus 8 shedding in the mouth and blood of hemodialysis patients.

In Saudi Arabia, the prevalence of transplantation-associated Kaposi's sarcoma (KS) is high, and there is disparity in the prevalence rates of human herpesvirus 8 (HHV-8) infection between patients with renal disease and the general population. It was hypothesized that oral HHV-8 transmission among patients undergoing hemodialysis treatment contributes to the high prevalence of infection in renal disease patients. The detection rates of anti-HHV8-IgG in plasma and HHV-8-DNA in CD45(+)-peripheral blood cells of 72 hemodialysis patients were compared first with those of 178 blood donors and 60 pregnant women. Between the hemodialysis patients and the apparently healthy people sampled, the detection rate of anti-HHV-8-IgG was 16.7% versus 0.4% (P < 0.001) and that of HHV-8-DNA was 4.2% versus 0.4%, (P < 0.05). HHV-8 DNA was determined in oral samples and the HHV-8 viral load measured in saliva of patients undergoing hemodialysis. The amount of virus shed into saliva ranged between 8,600 and 119,562,500 (mean: 24,009,360) genome-equivalents/ml among the five patients in whom oral HHV-8 DNA was detected. Finally, HHV-8-subgenomic sequencing was conducted which showed that orally shed HHV-8 in four patients belonged to genotype C2, and in one patient to genotypes A1 and C2. HHV-8 shed in the mouth of hemodialysis patients may be extensive and diverse. Oral fluid in addition to blood is thus a likely vehicle for transmission of HHV-8, possibly contributing to the high risk of HHV-8 infection in patients undergoing hemodialysis and to KS following immunosuppression after renal transplantation.