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.

It's not just an "oral cancer" exam.

The early identification and treatment of cancer of the head and neck, including oropharyngeal cancer (OPC), is associated with an improved survival rate. Specific efforts to promote screening to improve the early detection of OPC have come under scrutiny, largely due to the low prevalence of the disease. However, screening the patient for OPC does not occur as an isolated event in contemporary practice, but as an integral component of the hard and soft tissue examination to determine the totality of the patient's oral health. Three patient vignettes are presented to demonstrate that, regardless the outcome of the debate over OPC screening, the oral health care professional who performs a thorough examination of the head and neck is often in the best position to discover early cancer affecting the head and neck.

Oral Complications from Oropharyngeal Cancer Therapy.

Post-oropharyngeal cancer treatment complications include a multitude of oral side effects that impact overall survival and quality of life. These include acute and chronic conditions affecting the oral cavity and head and neck, such as mucositis, infection, xerostomia, dysgeusia, radiation caries, osteonecrosis, and trismus. This review will summarize the most common oral complications from oropharyngeal cancer therapy. The authors would like to point out that the literature cited frequently combines oropharyngeal and head and neck cancer results. If recommendations are made strictly related to oropharyngeal cancers, this will be highlighted.

Burnout in oral medicine and orofacial pain residents.

BACKGROUND: The authors sought to identify the prevalence of burnout in oral medicine (OM) and orofacial pain (OFP) residents and investigate potential contributing factors. METHODS: A cross-sectional questionnaire-based study was conducted. An anonymous 22-item online survey was emailed to the residents of all Commission on Dental Accreditation-accredited OM and OFP residency programs in the United States. Abbreviated Maslach Burnout Inventory was included to gauge the following details of burnout: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment. Questions also addressed the impact of residency program characteristics, work-life balance, and possible discrimination or abuse on burnout. RESULTS: Six OM and 12 OFP programs (72 residents) were contacted, and 46 residents responded (response rate, 64%). Overall prevalence of burnout was 35% (29% in OM residents, 40% in OFP residents). High EE burnout was noted in 57% of residents, high DP burnout in 11% of residents, and high personal accomplishment burnout in 59% of residents. Working for fewer than 40 hours per week was significantly associated with low DP burnout (P < .05). Moderate to high DP burnout was more prevalent in men and unmarried residents (whether in a relationship or not) were more likely to experience moderate to high EE burnout (P < .05). CONCLUSIONS: Burnout among OM and OFP residents is an emerging concern due to its detrimental effect on the physical and mental well-being of the residents. To the authors' knowledge, this study is the first to report burnout prevalence in the 2 most recent dental specialties recognized by the American Dental Association in 2020. PRACTICAL IMPLICATIONS: Early detection of signs of burnout among residents would allow program faculty and administrators to provide required support and resources.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a systematic review of outcome domains for salivary hypofunction.

OBJECTIVE: To identify all outcome measures used to assess salivary gland hypofunction (i.e., objective measures used to determine actual changes in saliva quantity or to assess response to treatment of salivary gland hypofunction) and to group these into domains. STUDY DESIGN: A systematic review including clinical trials and prospective or retrospective observational studies involving human participants with dry mouth, with any type of intervention where the objective assessment of salivary gland hypofunction was described. RESULTS: Five hundred fifty-three studies involving 31,507 participants were identified. Most assessed salivary gland hypofunction and xerostomia (68.7%), whereas 31.3% assessed salivary gland hypofunction alone. Most studies investigated the "amount of saliva," and the highest number of outcome measures were within the domain of "clinical/objective signs of salivary gland hypofunction." CONCLUSIONS: Seven domains encompassing 30 outcome measures were identified, confirming the diversity in outcomes and outcome measures used in research regarding salivary gland hypofunction. Identified items will be used in conjunction with those identified regarding xerostomia to create a core outcome set for dry mouth quantification for use in future clinical trials, with the overall goal of improving the standardization of reporting, leading to the establishment of more robust evidence for the management of dry mouth and improving patient care.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a systematic review of outcome domains for xerostomia.

OBJECTIVE: The purpose of this study was to identify all outcome domains used in clinical studies of xerostomia, that is, subjective sensation of dry mouth. This study is part of the extended project "World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research" to develop a core outcome set for dry mouth. STUDY DESIGN: A systematic review was performed on MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials databases. All clinical and observational studies that assessed xerostomia in human participants from 2001 to 2021 were included. Information on outcome domains was extracted and mapped to the Core Outcome Measures in Effectiveness Trials taxonomy. Corresponding outcome measures were summarized. RESULTS: From a total of 34,922 records retrieved, 688 articles involving 122,151 persons with xerostomia were included. There were 16 unique outcome domains and 166 outcome measures extracted. None of these domains or measures were consistently used across all the studies. The severity of xerostomia and physical functioning were the 2 most frequently assessed domains. CONCLUSION: There is considerable heterogeneity in outcome domains and measures reported in clinical studies of xerostomia. This highlights the need for harmonization of dry mouth assessment to enhance comparability across studies and facilitate the synthesis of robust evidence for managing patients with xerostomia.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a consensus study.

OBJECTIVE: This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions. STUDY DESIGN: Through 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group. RESULTS: After the 2-step consensus process, a consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of xerostomia, duration of xerostomia, the overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS. CONCLUSIONS: We propose a consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: the patient perspective.

OBJECTIVE: We conducted a qualitative study of patients' perspectives on dry mouth outcomes to explore their personal experiences and investigate which outcomes are most important to them. This work was part of the WONDER initiative (World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research) exploring Core Outcome Measures in Effectiveness Trials. STUDY DESIGN: Using a study-specific topic guide, we conducted digitally recorded, semi-structured interviews of focus groups of patients with dry mouth secondary to Sjögren syndrome and head and neck radiotherapy. We conducted interviews until data saturation had been achieved and evaluated all transcripts for accuracy before we anonymized the data. RESULTS: Two focus groups consisting of 4 participants per group identified 4 distinct themes: (1) impact on oral health and function, (2) social isolation and withdrawal, (3) frustration with dry mouth management, and (4) limited knowledge of the medical community and lack of understanding of family and friends. CONCLUSIONS: The diversity of self-reported outcomes and the complexity of patient perceptions identified in our work may represent additional barriers to successful dry mouth management that should be considered in the design of future clinical trials.

Oral hygiene and infective endocarditis: a case control study.

OBJECTIVE: To determine if oral hygiene is associated with infective endocarditis (IE) among those at moderate risk for IE. STUDY DESIGN: This is a case control study of oral hygiene among hospitalized patients with IE (cases) and outpatients with heart valve disease but without IE (controls). The primary outcome was the mean dental calculus index. Secondary outcomes included other measures of oral hygiene and periodontal disease (e.g., dental plaque, gingivitis) and categorization of blood culture bacterial species in case participants. RESULTS: The 62 case participants had 53% greater mean dental calculus index than the 119 control participants (0.84, 0.55, respectively; difference = 0.29, 95% CI: 0.11, 0.48; P = .002) and 26% greater mean dental plaque index (0.88, 0.70, respectively; difference = 0.18, 95% CI: 0.01.0.36; P = .043). Overall, cases reported fewer dentist and dental hygiene visits (P = .013) and fewer dental visits in the 12 weeks before enrollment than controls (P = .007). Common oral bacteria were identified from blood cultures in 27 of 62 cases (44%). CONCLUSIONS: These data provide evidence to support and strengthen current American Heart Association guidance that those at risk for IE can reduce potential sources of IE-related bacteremia by maintaining optimal oral health through regular professional dental care and oral hygiene procedures.

Effect of COVID-19 on training and mental health of oral medicine residents in North America.

OBJECTIVE: The objective of this study was to assess resident and faculty perception of the effect of the coronavirus disease 2019 pandemic on the training experience, education, and psychological well-being of oral medicine (OM) residents. STUDY DESIGN: An anonymous 16-item online questionnaire was e-mailed to faculty and residents of all Commission on Dental Accreditation-accredited OM residency programs in North America. Survey questions asked about the pandemic's effect on resident educational, clinical, and research activities and the well-being of the residents. Survey data were collected using Qualtrics XM. RESULTS: Forty participants (52.5% residents and 47.5% faculty members) responded to the survey. Regarding the effect on clinical activities, 67.5% reported 50% or less reduction in patient volume seen by residents at its worst during the pandemic. With respect to educational activities, most reported a complete switch of didactic training (85.3%), academic examinations (60%), and off-site resident rotations (45%) to a virtual platform. Research activities were affected the most; 55% reported complete cessation for some time. Thirty-three percent perceived a negative effect, 18% perceived no effect, 11% perceived a positive effect, and 38% were unsure regarding the effect of coronavirus disease 2019 on resident morale. Despite the interruptions in the clinical, research, and educational activities, 62.5% expected on-time resident graduation. CONCLUSION: Despite constraints due to the pandemic, OM residency programs successfully continued clinical activities, didactic training, and research productivity through virtual means and a hybrid delivery care model while supporting their residents' morale.

Salivary Gland Dysfunction Secondary to Cancer Treatment.

The number of cancer survivors are increasing and so are the oral toxicities from cancer therapy. Most patients receiving treatment for cancer develop some form of oral adverse events including, but not limited to, mucositis, opportunistic infections, dry mouth, and/or osteonecrosis of the jaw. One of the most common complications from head and neck cancer radiation therapy is salivary gland dysfunction (SGD). SGD is an umbrella term that includes the subjective sensation of dry mouth (xerostomia) and hyposalivation (objective reduction of the salivary flow rate). Dry mouth in cancer patients may lead to functional defects (e.g., eating, speaking, and swallowing), increase the risk of dental caries and oral candidiasis, and can have a negative effect on the nutritional and psychological status of the patients. The aim of this mini review was to summarize the current criteria for diagnosis and management of SGD associated with cancer treatment.

Osteonecrosis of the jaw secondary to haematopoietic stem cell transplantation.

Osteonecrosis of the jaw (ONJ) is necrosis of mandibular or maxillary bone, which sometimes leads to bone exposure and sequestration. There is evidence that the microenvironment of the marrow stromal system is severely and irreversibly damaged after haematopoietic stem cell transplantation (HSCT) leading to a deficit in the quantity and quality of osteoblastic progenitors, compromising the ability to regenerate a normal osteogenic cell population and abnormality in bone remodelling/turnover. While osteonecrosis of the appendicular skeleton is a common complication after HSCT, there have been no reports of an association with ONJ. This is a report of the first case of ONJ secondary to HSCT in a 69-year-old woman who developed a unique pattern of osteonecrosis involving all four quadrants of the jaw 2 months after allogeneic stem cell transplantation.

Bleeding risk in thrombocytopenic patients after dental extractions: a retrospective single-center study.

OBJECTIVE: The aim of the present study was to assess the clinical safety profile of dental extractions in patients with thrombocytopenia and explore the effectiveness of platelet transfusion before dental extractions. STUDY DESIGN: This is a retrospective cohort study of patients with moderate to severe (≤100,000/µL) thrombocytopenia who underwent dental extractions in the Oral Medicine and Dentistry Clinic at Brigham and Women's Hospital from 2003 to 2019. Patients with a platelet count <30,000/µL received prophylactic preprocedure platelet transfusion. Risk and type of bleeding complication (prolonged postoperative bleeding requiring intervention with topical hemostatic agents and/or therapeutic platelet transfusions) was assessed. RESULTS: Eighty-nine thrombocytopenic patients were identified. Postextraction bleeding complications occurred in 4 patients (4.4%). Surgical extractions and multiple number of extractions were significantly associated with an increased bleeding risk (P < .05), whereas prophylactic platelet transfusion and post-transfusion platelet count were not. CONCLUSIONS: Dental extractions in patients with thrombocytopenia may be performed with a positive safety profile by following a comprehensive medical evaluation, thorough treatment planning, adequate surgical management, use of local hemostatic measures, and, importantly, coordination of care with the patient's medical team.

Osteonecrosis of the jaw and dental extractions: A single-center experience.

OBJECTIVE: The aim of this study was to investigate the frequency of osteoradionecrosis/medication-related osteonecrosis of the jaw (ORN/MRONJ) after dental extraction with use of postextraction antibiotic coverage without prophylactic hyperbaric oxygen (HBO) in patients who received radiotherapy to head and neck (RT-HN) or antiresorptive medications and to determine possible associated factors. STUDY DESIGN: A retrospective study was conducted in patients who had a history of RT-HN or exposure to antiresorptives and who underwent dental extractions from 2003 to 2019. According to the clinical protocol, patients received amoxicillin 500 mg, 3 times daily (TID) for at least 14 days, and chlorhexidine 0.12% rinses, 2 times daily (BID), after extraction (or an alternative antibiotic if allergic to amoxicillin). HBO was not used for patients with RT-HN. RESULTS: Ninety patients underwent a total of 243 extractions. Fifty patients (55.5%) received a median of 54.1 Gray to the extraction site and 40 (44.4%) were on antiresorptives. None of the patients received both RT and antiresorptives. Of 40 patients, 3 (7.5%) developed MRONJ, and of 50 patients, 1 (2%) developed ORN. Among those at risk for MRONJ, male gender and concomitant immunosuppressant medications were associated with MRONJ development (P < .05). CONCLUSIONS: In our patient cohort, the rate of postextraction ORN/MRONJ was lower and comparable with the rates reported in the literature. Larger prospective studies are required to validate the efficacy of postextraction antibiotics in reducing ONJ.

Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study.

OBJECTIVE: The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP). STUDY DESIGN: Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test. RESULTS: Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58). CONCLUSIONS: Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.

Predictors of dental care use, unmet dental care need, and barriers to unmet need among women: results from NHANES, 2011 to 2016.

OBJECTIVES: To examine socio-demographic and economic predictors of dental care access among women in the United States. METHODS: A total of 52,493,940 women at the US national level aged 20-44 years were identified from the National Health and Nutrition Examination Survey, 2011 to 2016. Weighted multivariate logistic regression models were computed to identify predictors of dental care use, unmet dental-care need, and reported reasons for unmet need. RESULTS: Young, Mexican-American, other minority race-ethnicities, less educated, and uninsured women were independently more likely to have never visited a dental clinic (P < 0.025). Mexican-Americanwomen with a poverty income ratio (PIR) <2.00 and less than excellent health status and those uninsured were independently more likely to have unmet dental need (P < 0.025). Women with PIR <1.00 and those uninsured were independently more likely to have an unmet need because of unaffordable cost (P < 0.0008) or lack of procedure coverage by insurance (P < 0.0008). Younger women were more likely to think that the dental problem would go away (P < 0.0001). CONCLUSIONS: While young, less educated, and women from minority race-ethnicities were less likely to report ever use of dental care, only low income, poor health, and uninsured women were more likely to report unmet dental care need. Racial-ethnic minority, less educated, and young women may benefit from improved education about the value of dental care. Expanding insurance coverage for dental care and improving access for women with poor health may address racial-ethnic and education-level disparities in unmet dental care need.

Foreign body reaction to calcium hydroxylapatite after lip augmentation.

BACKGROUND: Dentists need to be aware of soft-tissue lesions resulting from cosmetic facial/lip procedures that involve the use of injectable materials. Common side effects detected on clinical examination may include edema, bruising and noninflammatory lip nodules. CASE DESCRIPTION: A 51-year-old woman visited a dental clinic with the chief complaint of a lump on the mucosal aspect of her lower lip. She reported having noted the lesion a few weeks before seeking care at the clinic. Several weeks later, the lesion persisted and new lesions were detected. The clinician excised the initial lesion only. CLINICAL IMPLICATIONS: The lip nodules were associated with a cosmetic procedure and were inflammatory in nature. This is the first granulomatous response reported as a result of injections with calcium hydroxylapatite (Radiesse, BioForm Medical, San Mateo, Calif.). Poor patient recollection of his or her medical history may result in confusion with pathological processes such as infection, neoplasia or malignancy.