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.

A systematic review of dental disease management in cancer patients.

INTRODUCTION: This systematic review aims to update on the prevalence of odontogenic-related infections and the efficacy of dental strategies in preventing dental-related complications in cancer patients since the 2010 systematic review. REVIEW METHOD: A literature search was conducted in the databases MEDLINE/PubMed and EMBASE for articles published between 1 January 2009 and 30 June 2016. Each study was assessed by 2 reviewers and the body of evidence for each intervention was assigned an evidence level. RESULTS: After examination of the abstracts and full-text articles, 59 articles satisfied the inclusion criteria. The weighted prevalence of dental infections and pericoronitis during cancer therapy was 5.4 and 5.3%, respectively. The frequency of dental-related infections during intensive chemotherapy after complete, partial, and minimal pre-cancer dental evaluation/treatment protocols ranged from 0 to 4%. Protocols involving third molars extractions had the highest complications (40%). CONCLUSIONS: In view of the low prevalence of infections and the potential for complications after third molar extractions, it is suggested that partial dental evaluation/treatment protocols prior to intensive chemotherapy; whereby minor caries (within dentin), asymptomatic third molars or asymptomatic teeth without excessive probing depth (<8 mm), mobility (mobility I or II) or with periapical lesions of <5 mm were observed; is a viable option when there is insufficient time for complete dental evaluation/treatment protocols. The use of chlorhexidine, fluoride mouth rinses as well as composite resin, resin-modified glass ionomer cement (GIC), and amalgam restorations over conventional GIC in post head and neck radiation patients who are compliant fluoride users is recommended.

Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study participants.

PURPOSE: Dental care after head and neck cancer (HNC) treatment is crucial to maintaining oral health and preventing/treating oral complications. This survey investigated the experiences and barriers to dental care post-radiation therapy (RT). METHODS: Participants of the Clinical Registry of Dental Outcomes in patients with head and neck cancer (OraRad) were surveyed at approximately 4 years post-RT. Participants completed a 20-question survey which assessed perceptions of dental care and education, barriers to receiving care, and ongoing physical symptoms post-RT. RESULTS: One hundred fifty-three of the 505 available OraRad participants completed the survey. Almost all of the respondents (n = 141; 92%) either strongly agreed or agreed that they understand the effects of cancer and its treatment on the teeth, mouth, and jaws. The majority (n = 119; 80%) strongly agreed or agreed that their dentist provided them with information on how to keep teeth, mouth, and jaws healthy after treatment. Most participants reported dry mouth (n = 114; 75%). Other sequelae were problems swallowing (n = 57; 38%), dental caries (n = 33; 22%), and difficulty keeping their mouth open during dental procedures (n = 26; 17%). CONCLUSIONS: The OraRad respondents reported few barriers to dental care post-HNC treatment. Patients continue to suffer oral/maxillofacial side effects of radiation treatment, most notably xerostomia.

Dental pain management with prescription opioids by nondental healthcare professionals in a healthcare system network.

OBJECTIVES: Patients with dental pain seek treatment in Urgent and Emergency Care settings by physicians and advanced practice practitioners (APPs) unable to provide definitive care, often relying on prescriptions for pain management including opioids. In the face of an opioid epidemic, this study assessed the impact of an electronic health record (EHR) clinical decision support tool to identify patients at high risk for opioid misuse using objective, evidence-based criteria, and guide safer prescribing. METHODS: Dental pain encounters occurring between January 2016 and June 2018 within our healthcare system were identified and linked to the database supporting a real-time clinical decision support intervention, Prescription Reporting with Immediate Medication Utilization Mapping (PRIMUM), to characterize opioid prescribing patterns and prescribers' response to alert. Descriptive analysis of the data was performed. RESULTS: There were 30,649 dental pain encounters of which opioids were written in 45.5 percent (N = 13,957) encounters. A total of 16.6 percent of patients prescribed an opioid had a risk factor for misuse and triggered the PRIMUM alert at the point of care. In response to the PRIMUM alert (N = 2,501 encounters), clinician decision-making was influenced in 9.5 percent (N = 237) of encounters, which was defined by cancelation of the original opioid prescription. Of those 9.5 percent encounters, 48.1 percent (N = 114) resulted in no opioid prescription written. CONCLUSIONS: There is potential for a clinical decision support tool embedded in the EHR to guide safer prescribing practice by alerting providers to objective, evidence-based risk characteristics at the point of care.

A systematic review of dental disease in patients undergoing cancer therapy.

INTRODUCTION: This purpose of this systematic review was to evaluate the literature and update our current understanding of the impact of present cancer therapies on the dental apparatus (teeth and periodontium) since the 1989 NIH Development Consensus Conference on the Oral Complications of Cancer Therapies. REVIEW METHOD: A systematic literature search was conducted with assistance from a research librarian in the databases MEDLINE/PubMed and EMBASE for articles published between 1 January 1990 and 31 December 2008. Each study was independently assessed by two reviewers. Taking into account predetermined quality measures, a weighted prevalence was calculated for the prevalence of dental caries, severe gingival disease, and dental infection. Data on DMFT/dmft, DMFS/dmfs, plaque, and gingival indexes were also gathered. The level of evidence, recommendation, and guideline (if possible) were given for published preventive and management strategies. RESULTS: Sixty-four published papers between 1990 and 2008 were reviewed. The weighted overall prevalence of dental caries was 28.1%. The overall DMFT for patients who were post-antineoplastic therapy was 9.19 (SD, 7.98; n = 457). The overall plaque index for patients who were post-antineoplastic therapy was 1.38 (SD, 0.25; n = 189). The GI for patients who were post-chemotherapy was 1.02 (SD, 0.15; n = 162). The weighted prevalence of dental infections/abscess during chemotherapy was reported in three studies and was 5.8%. CONCLUSIONS: Patients who were post-radiotherapy had the highest DMFT. The use of fluoride products and chlorhexidine rinses are beneficial in patients who are post-radiotherapy. There continues to be lack of clinical studies on the extent and severity of dental disease that are associated with infectious complications during cancer therapy.

A systematic review of orofacial pain in patients receiving cancer therapy.

PURPOSE: We present the findings of a structured systematic review of the literature assessing orofacial pain induced by malignant disease and/or its therapy (excluding mucositis). This evaluation of the literature published after the 1989 NIH Development Consensus conference on the oral complications of cancer therapies is an effort to assess the prevalence of pain, quality of life and economic impact, and management strategies for cancer therapy-induced orofacial pain. METHODS: A systematic medical literature search was conducted with assistance from a research librarian in MEDLINE/PubMed and EMBASE databases for articles published between January 1, 1990 and December 31, 2008. Each study was independently assessed by two reviewers with expertise in the field of oral oncology. RESULTS: Thirty-nine studies assessed pain in the head and neck region. The measure was commonly embedded in quality of life studies. Most of these studies described pain in head and neck cancer (HNC) patients, which therefore became the focus of the report. Pain is common in patients with HNC and is reported by approximately half of patients prior to cancer therapy, 81% during therapy, 70% at the end of therapy, and by 36% at 6 months after treatment. Pain is experienced beyond the 6-month period by approximately one third of patients and is typically more severe than pre-treatment cancer-induced pain. CONCLUSIONS: This systematic review identified the presence of pain before cancer therapy, likely attributable to the cancer; an increase in pain during therapy and the common persistence of pain following cancer treatment. Continuing research should use validated tools to prospectively assess orofacial pain, its causes and pathophysiology, and its effect on quality of life and economic impact. Clinical trials of pain management in this setting are also warranted.

Frequency of bleeding following invasive dental procedures in patients on low-molecular-weight heparin therapy.

PURPOSE: The purpose of this study was to determine the frequency of bleeding complications after invasive dental procedures in patients on low-molecular-weight heparin (LMWH) therapy. MATERIALS AND METHODS: A chart review of patients who underwent invasive dental procedures while on LMWH therapy was conducted. The following information was obtained: demographics, medical history, social history, medications, relevant laboratory values, postoperative bleeding events, and use of local hemostatic agents and blood products. RESULTS: Forty-one patients (21 men) were identified with 42 dental appointments. The mean age was 48 years (range, 16 to 78 years). Thirty-seven patients (90%) were on LMWH therapy for deep venous thrombosis prophylaxis. Thirty-one patients (76%) were on concomitant medications that may potentiate bleeding. Multiple dental extractions (range, 2 to 14 teeth) were performed during 19 dental appointments. Twenty-one appointments were for single-tooth extraction and 2 were for soft tissue biopsies. Three patients (7%) had postextraction bleeding events. All 3 patients were on LMWH (enoxaparin) and warfarin therapy concurrently. One patient had persistent bleeding after extraction of 4 teeth (international normalized ratio, 1.6), which was successfully controlled with topical thrombin, administration of vitamin K and fresh frozen plasma, and discontinuation of enoxaparin and warfarin. Postoperative bleeding in the other 2 patients was managed successfully with local hemostatic measures and home care instructions. CONCLUSION: Our study suggests that, although postoperative bleeding in patients on LMWH therapy alone is rare to nonexistent, patients on warfarin and LMWH may be at increased risk of bleeding after invasive dental procedures.

Oral Manifestations of Systemic Diseases.

Signs and symptoms representative of a systemic condition can manifest in the oral cavity and orofacial region. Such conditions may be previously diagnosed, or the orofacial manifestation may be the presenting sign of an acute or chronic systemic condition not previously diagnosed. Pathologic processes in the mouth, jaws, and contiguous structures could have a direct and indirect impact on the patient's overall systemic condition. Moreover, systemic conditions may result in compromised function of the orofacial region or impact patients' oral health profile. This article reviews selected systemic conditions that present or impact on the oral cavity and orofacial region.

Impact of salivary hypofunction on incidence of orofungal infections with use of topical steroids for management of oral lichen planus and xerostomia.

OBJECTIVES: The aim of this study was to determine if salivary hypofunction increases the incidence of oral fungal infections (OFIs) after topical steroid use for the management of oral lichen planus (OLP). STUDY DESIGN: Patients with a diagnosis of OLP, treated for at least 2 weeks with topical steroids, had baseline salivary flow evaluations completed, and had a follow-up visit within 5 weeks of steroids being prescribed were assessed. Patients were evaluated for clinical signs of fungal infection at follow-up visits. RESULTS: Forty-Seven patients (91% female) met the inclusion criteria, with 21.3% developing an OFI after topical steroid use. Demographic characteristics, type of OLP, steroid used, and antifungal used did not impact the development of an OFI. The mean stimulated salivary flow was significantly lower in the group that developed an OFI compared with the group that did not develop an OFI (8.31 mL/15 min vs 15.4 mL/15 min, respectively; P = 0.0006). A higher incidence of OFIs occurred in the low stimulated flow group versus the normal flow group (39% vs 4%, respectively). Most patients in the OFI group received a preventative antifungal (90%). CONCLUSIONS: OFIs increased after steroid treatment in patients with OLP who had low stimulated salivary flows. Antifungals (90%) were not effective in preventing OFIs in patients with OLP who had salivary hypofunction and were treated with topical steroids.

Oral mucositis: review of pathogenesis, diagnosis, prevention, and management.

Oral mucositis is a debilitating and morbid condition among cancer patients that affects their quality of life and their overall ability to respond to treatment. The dentist plays an important role in the multidisciplinary health care team for the overall management of this condition. This article summarizes preventive and therapeutic treatment modalities available to dentists, based on the latest literature.

Intraoral Pain Disorders.

Those experiencing intraoral pain associated with dental and oral diseases are likely to pursue treatment from medical and dental providers. The causes for intraoral pain include odontogenic, periodontal, oral mucosal, or contiguous hard and soft tissue structures to the oral cavity. Providers should be vigilant when diagnosing these, as they should be among the first in their differential diagnoses to be ruled out. This review provides brief overviews of frequently encountered oral/dental diseases that cause intraoral pain, originating from the teeth, the surrounding mucosa and gingivae, tongue, bone, and salivary glands and their causes, features, diagnosis, and management strategies.

Oral manifestations of patients with lupus erythematosus.

Lupus erythematosus manifests as cutaneous variants, such as discoid lupus erythematosus or systemic lupus erythematosus. Systemic lupus erythematosus is a multisystem autoimmune disease characterized by general autoantibody production and a wide range of mucocutaneous, renal, neuropsychiatric, cardiovascular, infectious, and hematologic manifestations. This article discusses the prevalence of and considerations for oral mucosal lesions in lupus erythematosus and the impact of the various disease manifestations of systemic lupus erythematosus on dental management.

World Workshop on Oral Medicine VI: Controversies regarding dental management of medically complex patients: assessment of current recommendations.

OBJECTIVES: Current recommendations for safe and effective dental management are less than optimal for some medical conditions because of limited evidence, conflicting conclusions, or both. This review (1) compiled and evaluated dental management recommendations for select medical conditions; (2) summarized recommendations and their assigned levels of evidence; (3) identified areas of conflict, ambiguity, or both; and (4) identified issues that warrant future research, enhanced consensus statements, or both. STUDY DESIGN: Systematic literature searches were performed for guideline publications, systematic and narrative reviews, and opinion documents containing recommendations for (1) medication-related osteonecrosis of the jaw (MRONJ); (2) cardiovascular diseases (CVDs); (3) prosthetic joints (PJs); and (4) systemic steroid therapy (SST). RESULTS: The search yielded the following numbers of publications that met the inclusion criteria: MRONJ - 116; CVDs - 54; prosthetic joints - 39; and systemic steroids - 12. CONCLUSIONS: Very few of the compiled recommendations were assigned or linked to levels of evidence by their authors. Key conclusions include the following: MRONJ-expert recommendations trend toward proceeding with dental treatment with little to no modification in osteoporotic patients on bisphosphonates; CVDs-current recommendations are primarily directed to general surgery and applied to dentistry; PJs-routine antibiotic prophylaxis is not indicated for dental treatment; and SST-steroid supplementation is not indicated for most patients undergoing dental procedures under local anesthesia.

Oral complications of Sjögren's syndrome.

Numerous oral manifestations associated with salivary gland dysfunction, and particularly Sjögren's syndrome, have been reported in the literature. This article discusses the evidence on a wide range of oral manifestations associated with Sjögren's syndrome.

Intraoral pain disorders.

Dental and oral diseases are common findings in the general population. Pain associated with dental or periodontal disease is the primary reason why most patients seek treatment from providers. Thus, it is essential that all complaints of pain in the mouth and face include ruling out pain of dental origin. However, intraoral pain is not exclusively a result of dental disorders. This review outlines common somatic intraoral pain disorders, which can originate from disease involving one or more broad anatomic areas: the teeth, the surrounding soft tissues (mucogingival, tongue, and salivary glands), and bone.

Salivary flow rates among women diagnosed with benign and malignant tumors.

The purpose of this study was to compare salivary flow rates (SWS) among patients diagnosed with benign and varying malignant solid tumors with the comparison group, prior to the initiation of any treatment. An evaluation of the results found that mean baseline SWS flow rates were higher for healthy patients (1.55 ml/min) when compared to patients diagnosed with benign tumors (1.13 ml/min), breast cancer (1.09 ml/min), and reproductive carcinomas (0.94 ml/min). The overall model (F = 7.76; p < .001) and the Dunnett's post hoc analyses were statistically significant at the p < .001 level. Additionally, medications, race, and season of the year had significant effects on mean SWS flow rates. The results suggest that salivary secretion is lower among both benign and malignant tumor subjects prior to the initiation of treatment. Salivary evaluations of subjects prior to treatment may be useful in identifying individuals at risk for oral complications during chemotherapy.

Review of postoperative bleeding risk in dental patients on antiplatelet therapy.

OBJECTIVE: We conducted a review of the literature to assess risk for oral bleeding complications after dental procedures in patients on antiplatelet therapy. STUDY DESIGN: We conducted a search in Medline, Embase, and National Guideline Clearinghouse databases for studies involving patients on single and dual antiplatelet therapy that had invasive dental procedures or manipulations that induce oral bleeding. RESULTS: The literature search yielded 15 studies that met inclusion criteria. There is a trend toward increased occurrence of immediate postoperative bleeding for dual antiplatelet therapy, but there is no increase in the occurrence of intra- or late postoperative bleeding complications. CONCLUSIONS: We found no clinically significant increased risk of postoperative bleeding complications from invasive dental procedures in patients on either single or dual antiplatelet therapy. These findings support the recommendation that there is no indication to alter or stop these drugs, and that local hemostatic measures are sufficient to control bleeding.

Risk of postoperative bleeding after dental procedures in patients on warfarin: a retrospective study.

OBJECTIVES: The purpose of this retrospective study was to investigate the frequency of bleeding complications after invasive dental procedures in warfarinized patients and the possible risk factors. STUDY DESIGN: The CoaguChek System was used to obtain an in-office international normalized ratio (INR) value for 122 patients (240 appointments), of which the mean age was 57.0 ± 15.9 years and 50% were males. Demographic and clinical information were obtained retrospectively from dental and medical records. RESULTS: Five episodes (mean INR: 2.0 ± 0.8) of persistent bleeding were identified; 4 were after extractions and 1 was after implant placement. The frequency of bleeding was 4.8%, if only considering surgical procedures. Postoperative bleeding was significantly higher (P < .05) in patients who were taking anti-thrombotic medications in addition to warfarin. CONCLUSIONS: There is a low incidence of persistent bleeding after invasive dental procedures in warfarinized patients but the risk appears to increase with the use of concomitant anti-thrombotic medications.