Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in adolescents, adults, and older adults: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh, and the University of Pennsylvania.

BACKGROUND: A panel convened by the American Dental Association Science and Research Institute, the University of Pittsburgh, and the University of Pennsylvania conducted systematic reviews and meta-analyses and formulated evidence-based recommendations for the pharmacologic management of acute dental pain after simple and surgical tooth extraction(s) and for the temporary management (ie, definitive dental treatment not immediately available) of toothache associated with pulp and periapical diseases in adolescents, adults, and older adults. TYPES OF STUDIES REVIEWED: The panel conducted 4 systematic reviews to determine the effect of opioid and nonopioid analgesics, local anesthetics, corticosteroids, and topical anesthetics on acute dental pain. The panel used the Grading of Recommendations, Assessment, Development and Evaluation approach to assess the certainty of the evidence and the Grading of Recommendations, Assessment, Development and Evaluation Evidence-to-Decision Framework to formulate recommendations. RESULTS: The panel formulated recommendations and good practice statements using the best available evidence. There is a beneficial net balance favoring the use of nonopioid medications compared with opioid medications. In particular, nonsteroidal anti-inflammatory drugs alone or in combination with acetaminophen likely provide superior pain relief with a more favorable safety profile than opioids. CONCLUSIONS AND PRACTICAL IMPLICATIONS: Nonopioid medications are first-line therapy for managing acute dental pain after tooth extraction(s) and the temporary management of toothache. The use of opioids should be reserved for clinical situations when the first-line therapy is insufficient to reduce pain or there is contraindication of nonsteroidal anti-inflammatory drugs. Clinicians should avoid the routine use of just-in-case prescribing of opioids and should exert extreme caution when prescribing opioids to adolescents and young adults.

Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania.

BACKGROUND: A guideline panel convened by the American Dental Association Council on Scientific Affairs, American Dental Association Science and Research Institute, University of Pittsburgh School of Dental Medicine, and Center for Integrative Global Oral Health at the University of Pennsylvania conducted a systematic review and meta-analyses and formulated evidence-based recommendations for the pharmacologic management of acute dental pain after 1 or more simple and surgical tooth extractions and the temporary management of toothache (that is, when definitive dental treatment not immediately available) associated with pulp and furcation or periapical diseases in children (< 12 years). TYPES OF STUDIES REVIEWED: The authors conducted a systematic review to determine the effect of analgesics and corticosteroids in managing acute dental pain. They used the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty of the evidence and the Grading of Recommendations Assessment, Development and Evaluation Evidence to Decision framework to formulate recommendations. RESULTS: The panel formulated 7 recommendations and 5 good practice statements across conditions. There is a small beneficial net balance favoring the use of nonsteroidal anti-inflammatory drugs alone or in combination with acetaminophen compared with not providing analgesic therapy. There is no available evidence regarding the effect of corticosteroids on acute pain after surgical tooth extractions in children. CONCLUSIONS AND PRACTICAL IMPLICATIONS: Nonopioid medications, specifically nonsteroidal anti-inflammatory drugs like ibuprofen and naproxen alone or in combination with acetaminophen, are recommended for managing acute dental pain after 1 or more tooth extractions (that is, simple and surgical) and the temporary management of toothache in children (conditional recommendation, very low certainty). According to the US Food and Drug Administration, the use of codeine and tramadol in children for managing acute pain is contraindicated.

Implementation and analysis of an enhanced screening and testing protocol for prediabetes in a dental school patient population.

OBJECTIVES: This project aimed to enhance the identification of patients at-risk for prediabetes or diabetes within a dental school patient population by introduction of a modified screening tool and related training of dental residents and students. METHODS: The American Diabetes Association Risk Tool (ADART) was modified by addition of three diabetes-linked oral health questions. Of the 1477 dental patients screened, 551 (37.3%) indicated an at-risk status using the modified tool. A subset of 138 patients received follow-up chairside HbA1c blood testing conducted by dental residents and students. Data was analysed to determine a) the influence of the modifications on the tool's discrimination strength and b) change in the tool's predictive value. RESULTS: The addition of the 3 oral health questions to the 7-item ADART resulted in a 9.4% increase in identification of patients at-risk for pre-diabetes/diabetes. The predictive value of the tool remained stable. Residents and students successfully incorporated the new screening activities within their assigned clinics. CONCLUSIONS: This project demonstrates that screening for risk for prediabetes/diabetes is both prudent and practical in the dental setting. Dental personnel, including trainees, can successfully incorporate enhanced screening methods within their traditional activities. Further, screening tools used in the dental setting might be enhanced by inclusion of certain oral health variables associated with diabetes. These findings add to emerging knowledge on the importance of screening for prediabetes/diabetes in dental settings and have particular relevance and application to institutional practice.

Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer.

PURPOSE: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND METHODS: A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading. RESULTS: Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing. CONCLUSION: GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.

Oral Mucositis Due to High-Dose Chemotherapy and/or Head and Neck Radiation Therapy.

Oral mucositis is a common side-effect associated with conventional cancer therapy and has also recently been reported in association with newly emerging cancer therapies. It is characterized as an inflammation of the oral mucous membranes accompanied by many complex mucosal and submucosal changes. Ulcerative oral mucositis can cause significant oral pain, impair nutritional intake, lead to local or systemic infection, and cause significant economic cost. In addition, it may necessitate interruptions in cancer therapy, thus adversely affecting patient prognosis. This review presents the current understanding of the pathogenesis of mucositis and discusses evidence-based clinical management strategies for oral mucositis. In addition, key research questions for future investigation are identified, followed by a discussion of strategies to promote development and funding of the needed research.

Use of the Dental Electronic Health Record for Research: Assessing Demographic and Oral Health Characteristics Data for Clinic Patients.

Dental schools in the United States increasingly emphasize community-based practice targeting underserved populations. However, the impact on target populations remains largely undocumented. East Carolina University School of Dental Medicine (ECU SoDM) developed an integrated electronic health record database that aggregates patient data from all clinics in the ECU SoDM system and enables longitudinal assessment of the impact of clinical care on oral health outcomes. The aim of this study was to analyze the demographic and oral health characteristics data for eligible patients from June 2012 to March 2016. Data from 28,029 eligible patients were included. Except for expected variations in racial composition, the demographic data were similar across ECU SoDM clinics and indicated that the patient population represents a geographically diverse sample of outpatients. The mean decayed, missing, and filled teeth (DMFT) index was elevated in this population. Among the trends identified across subgroups were higher DMFT index in older patients and lower DMFT index for individuals of Hispanic or Latino ethnicity. Although the percentage of patients with dental caries overall rose steadily with age, the percentage with untreated dental caries generally fluctuated around 33%±5% without age-related trends. These data provide a baseline for evaluating changes over time and the impact of oral health care introduced to areas served by the ECU SoDM. These findings highlight the need for access to care and support the ECU SoDM's core mission.

Risk Factors for Facial Pain: Data from the Osteoarthritis Initiative Study.

AIMS: Temporomandibular disorder (TMD) is believed to be co-morbid with rheumatologic conditions such as Osteoarthritis (OA). We determine 30-day prevalence and cumulative incidence, and risk factors for facial pain in a cohort of subjects who either had or were at risk of developing symptomatic radiographic knee osteoarthritis (SRKOA). METHODS: Poisson regression models examined whether age, sex, race, Center for Epidemiologic Studies-Depression Scale (CES-D) score, number of painful joints, and presence of SRKOA were risk factors for facial pain in 4,423 subjects at baseline and in 3,472 subjects at 24 and/or 48 months follow-up. RESULTS: At baseline, 30-day period prevalence of facial pain was 9.25%; and 30-day cumulative incidence at 24-months and at 48-months was 5.9% and 4.9%, respectively. Factors associated with prevalence and incidence of facial pain were: younger age, female sex, (CES-D) score, and a larger number of painful joints. For each increase in age of one year, the incidence of facial pain decreased by 1%. Women had a 96% higher incidence than men, and each unit increase of (CES-D) score was associated with a 2% increase in the incidence of facial pain. For every additional painful joint, there was a 21% increase in the incidence of facial pain. Subjects with SRKOA had a 33% increase in the incidence of facial pain compared to those with risk factors for SRKOA. CONCLUSION: OA and TMD share several risk factors. The risk factors identified in cross-sectional analysis of prevalence are similar to those identified in longitudinal analysis on incidence.

Prescribing Opioid Analgesics for Acute Dental Pain: Time to Change Clinical Practices in Response to Evidence and Misperceptions.

As the nation comes to terms with a prescription opioid epidemic, dentistry is beginning to understand its own unintentional contribution and seek ways to address it. The article urges dental providers to reexamine entrenched prescribing habits and thought patterns regarding treatment of acute dental pain. It points to evidence suggesting that nonsteroidal anti-inflammatory drugs are nonaddictive and usually more effective for managing many cases of acute dental pain. The authors provide therapeutic recommendations to help dental providers change prescribing patterns.

Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth.

BACKGROUND: The authors compared the local anesthetic efficacy and safety of an intranasally administered formulation of tetracaine and oxymetazoline (K305) with placebo in adult participants undergoing single dental restorative procedures in teeth nos. 4 through 13. METHODS: The authors screened and allocated 150 participants in a double-masked, randomized fashion to either K305 or placebo nasal spray. The authors delivered the study drug as two 0.2-milliliter sprays separated by 4 minutes inside the nostril on the side ipsilateral to the tooth being treated. The authors administered a third 0.2-mL spray, if necessary, and administered 4% articaine with 1:200,000 epinephrine by means of injection if anesthesia was inadequate. Safety evaluations included participant reports of adverse events, vital signs, and alcohol sniff tests during the 2-hour study period and at a 1-day follow-up visit. The primary efficacy end point was anesthetic success defined as the completion of the dental procedure without the need for rescue injectable local anesthetic. The authors evaluated differences in success rates observed between K305 and placebo by using a 1-sided Fisher exact test. RESULTS: The overall success rates were 88.0% (95% confidence interval, 80.0-93.6) and 28% (95% confidence interval, 16.2-42.5) for K305 and placebo, respectively (P < .0001). The most frequent adverse effects in the K305 group were rhinorrhea (57.0%) and nasal congestion (26.0%). No serious adverse events occurred during this study. CONCLUSIONS: K305 was effective and well tolerated during restorative procedures in adult participants. PRACTICAL IMPLICATIONS: K305 provides a needleless alternative for obtaining maxillary pulpal anesthesia on premolars, canines, and incisors.

Prescription of opioid analgesics for nontraumatic dental conditions in emergency departments.

BACKGROUND: Opioid analgesics prescribed for nontraumatic dental conditions (NTDCs) by emergency physicians continue to receive attention because of the associated potential for misuse, abuse and addiction. This study examined rates of prescription of opioid analgesics and types of opioid analgesics prescribed for NTDC visits in U.S. emergency departments. METHODS: Data from the National Hospital Ambulatory Medical Care Survey from 2007 to 2010 were analyzed. Descriptive statistics and logistic regression analysis were performed and adjusted for the survey design. RESULTS: NTDCs made up 1.7% of all ED visits from 2007 to 2010. The prescription of opioid analgesics was 50.3% for NTDC and 14.8% for non-NTDC visits. The overall rate of opioid analgesics prescribed for NTDCs remained fairly stable from 2007 through 2010. Prescription of opioids was highest among patients aged 19-33 years (56.8%), self-paying (57.1%), and non-Hispanic Whites (53.2%). The probability of being prescribed hydrocodone was highest among uninsured patients (68.7%) and for oxycodone, it was highest among private insurance patients (33.6%). Compared to 34-52 year olds, children 0-4 years were significantly more likely to be prescribed codeine and less likely to be prescribed oxycodone. Compared to non-Hispanic Whites, non-Hispanic Blacks had significantly higher odds of been prescribed codeine and somewhat lower odds of been prescribed oxycodone, but it was not statistically significant. CONCLUSIONS: There was no significant change in the rates of opioid analgesics prescribed over time for NTDC visits to EDs. Age, payer type and race/ethnicity were significant predictors for the prescription of different opioid analgesics by emergency physicians for NTDC visits.

Changing Paradigms for Acute Dental Pain: Prevention Is Better Than PRN.

A B S T R A C T The drugs available for the management of acute orofacial pain have changed very little since the introduction of ibuprofen into practice 40 years ago. Orally effective opioids, acetaminophen, aspirin and NSAIDs remain the mainstay of analgesic therapy. Increased recognition of the societal and personal impact of opioid diversion and abuse requires re-examination of the traditional approach of prescribing an opioid-containing analgesic combination to be administered by the patient "as needed" (PRN) starting postoperatively.

Study protocol, sample characteristics, and loss to follow-up: the OPPERA prospective cohort study.

UNLABELLED: When studying incidence of pain conditions such as temporomandibular disorder (TMD), repeated monitoring is needed in prospective cohort studies. However, monitoring methods usually have limitations and, over a period of years, some loss to follow-up is inevitable. The OPPERA prospective cohort study of first-onset TMD screened for symptoms using quarterly questionnaires and examined symptomatic participants to definitively ascertain TMD incidence. During the median 2.8-year observation period, 16% of the 3,263 enrollees completed no follow-up questionnaires, others provided incomplete follow-up, and examinations were not conducted for one third of symptomatic episodes. Although screening methods and examinations were found to have excellent reliability and validity, they were not perfect. Loss to follow-up varied according to some putative TMD risk factors, although multiple imputation to correct the problem suggested that bias was minimal. A second method of multiple imputation that evaluated bias associated with omitted and dubious examinations revealed a slight underestimate of incidence and some small biases in hazard ratios used to quantify effects of risk factors. Although "bottom line" statistical conclusions were not affected, multiply-imputed estimates should be considered when evaluating the large number of risk factors under investigation in the OPPERA study. PERSPECTIVE: These findings support the validity of the OPPERA prospective cohort study for the purpose of investigating the etiology of first-onset TMD, providing the foundation for other papers investigating risk factors hypothesized in the OPPERA project.

Clinical orofacial characteristics associated with risk of first-onset TMD: the OPPERA prospective cohort study.

UNLABELLED: Case-control studies have documented clinical manifestations of chronic temporomandibular disorder (TMD), whereas clinical predictors of TMD development are largely unknown. We evaluated 41 clinical orofacial characteristics thought to predict first-onset TMD in a prospective cohort study of U.S. adults aged 18 to 44 years. During the median 2.8-year follow-up period, 2,737 people completed quarterly screening questionnaires. Those reporting symptoms were examined and 260 people were identified with first-onset TMD. Univariate and multivariable Cox regression models quantified associations between baseline clinical orofacial measures and TMD incidence. Significant predictors from baseline self-report instruments included oral parafunctions, prior facial pain and its life-impact, temporomandibular joint noises and jaw locking, and nonspecific orofacial symptoms. Significant predictors from the baseline clinical examination were pain on jaw opening and pain from palpation of masticatory, neck, and body muscles. Examiner assessments of temporomandibular joint noise and tooth wear facets did not predict incidence. In multivariable analysis, nonspecific orofacial symptoms, pain from jaw opening, and oral parafunctions predicted TMD incidence. The results indicate that only a few orofacial examination findings influenced TMD incidence, and only to a modest degree. More pronounced influences were found for self-reported symptoms, particularly those that appeared to reflect alterations to systems beyond the masticatory tissues. PERSPECTIVE: OPPERA's prospective cohort study identifies predictors of first-onset TMD comprising self-reported orofacial symptoms and examination findings. The results suggest a complex pattern of TMD etiology that is influenced by disorders locally, in masticatory tissues, and systemically, in pain-regulatory systems.

An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: efficacy, tolerability and compliance with label dose administration directions.

BACKGROUND: The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain. METHODS: Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied. RESULTS: The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤ .05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤ .05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less. CONCLUSIONS: Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications. Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.

Delirium: a very common problem you may not recognize.

Older adults with multiple pre-existing conditions are admitted to hospitals with acute illnesses and injuries every day. Delirium is not recognized by clinicians across health care settings. With awareness of risk factors and knowledge of delirium, nurses can play a pivotal role in the early identification, treatment, and, most important, prevention of delirium in older adults. Nurses often display a lack of knowledge related to delirium and the complex symptoms that appear differently in the presence of other complicating co-morbid conditions in aging adults. Nurses play a crucial role in keeping patients safe and ensuring optimal outcomes, regardless of the setting. With the growing population of older adults and the expected increases in chronic illness and dementia, delirium is a problem nurses are likely to experience in all practice settings. Knowing what to look for facilitates recognizing the risk and acting early to minimize (or even prevent) delirium.

Delirium and sedation recognition using validated instruments: reliability of bedside intensive care unit nursing assessments from 2007 to 2010.

OBJECTIVES: To describe the reliability and sustainability of delirium and sedation measurements of bedside intensive care unit (ICU) nurses. DESIGN: Prospective cohort study. SETTING: A tertiary care academic medical center. PARTICIPANTS: Five hundred ten ICU patients from 2007 to 2010; 627 bedside nurses. MEASUREMENTS: Bedside nurses and well-trained reference-rater research nurses independently measured delirium and sedation levels in routine care. Bedside nurses were instructed to use the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) every 12 hours to measure delirium and the Richmond Agitation-Sedation Scale (RASS) every 4 hours to measure sedation. CAM-ICU and RASS assessment agreement were computed using weighted kappa statistics across the entire population and subgroups (e.g., ICU type). Sensitivity and specificity of bedside nurse identification of delirium were calculated to understand sources of discordance. RESULTS: Six thousand one hundred ninety-eight CAM-ICU and 6,880 RASS measurement pairs obtained on 3,846 patient-days. For CAM-ICU measurements, agreement between bedside and research nurses was substantial (weighted kappa = 0.67, 95% confidence interval (CI) = 0.66-0.70) and stable over 3 years of data collection. RASS measures also demonstrated substantial agreement (weighted kappa = 0.66, 95% CI = 0.64-0.68), which was stable across all years of data collection. The sensitivity of delirium nurse assessments was 0.81 (95% CI = 0.78-0.83), and the specificity was 0.81 (95% CI = 0.78-0.85). CONCLUSION: Bedside nurse measurements of delirium and sedation are sustainable and reliable sources of information. These measures can be used for clinical decision-making, quality improvement, and quality measurement activities.

Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity.

BACKGROUND: Available screening instruments for identifying temporomandibular disorders (TMDs) exhibit methodological or logistic limitations. The authors conducted a study to develop and assess the validity of a self-report instrument in screening patients for pain-related TMDs. METHODS: By using psychometric methods for item selection, the authors developed short (three-item) and long (six-item) versions of the questionnaire and evaluated them for validity among 504 participants. RESULTS: Internal reliability was excellent, with coefficient α values of 0.87 and 0.93 for the short and long versions, respectively. When the authors dichotomized instrument scores at optimal thresholds, both versions had a sensitivity of 99 percent and a specificity of 97 percent for correct classification of the presence or absence of TMD. The specificity was at least 95 percent in the correct identification of people with nonpainful TMJ disorders or headahce without TMD pain. CONCLUSIONS: With use of appropriate psychometric methodology, the selected items exhibited excellent content validity. The excellent levels of reliability, sensitivity and specificity demonstrate the validity and usefulness of this instrument. CLINICAL IMPLICATIONS: Using this instrument will allow clinicians to identify more readily-and cost-effectively-most patients with painful TMD conditions for whom early and reliable identification would have a significant effect on diagnosis, treatment and prognosis.

Long-acting local anesthetics and perioperative pain management.

Although the use of long-acting local anesthetics has become a useful therapeutic approach for managing peri- and postoperative pain, recent evidence reveals unexpected outcomes. This article reviews the clinical use of long-acting local anesthetics, presents current clinical research findings, and makes recommendations for their use.