Opioid, NSAID, and OTC Analgesic Medications for Dental Procedures: PEARL Network Findings.

OBJECTIVE: Dental treatment is often categorized as a moderately or severely painful experience; however, no clinical data reported by the patient and dentist currently exists to support this degree of pain. This has contributed possibly to the overprescribing of analgesics, in particular the opioid class of medications. The primary objective of the study was to document the dentists' postprocedural prescriptions and recommendations for analgesic medications and their effectiveness for a 5-day period. Medications prescribed or recommended in the patient-reported outcomes included: opioid, nonsteroidal anti-inflammatory drugs (NSAIDs), and over-the-counter (OTC) analgesics. Met hods : This study used both dentist and patient responses to evaluate the use of opioid, NSAID, and OTC recommended or prescribed analgesics following one of seven classes of dental procedures encompassing over 22 specific coded procedures thought to elicit pain. The patient-centered study included a 5-day postprocedural patient follow-up assessment of the medication's effectiveness in relieving pain. RESULTS: Baseline questionnaires were completed by 2765 (99.9%) of 2767 eligible patients, and 2381 (86%) patients responded to the Day 5 follow-up questionnaires. CONCLUSION: The data suggest NSAIDs, both OTC and prescribed dosages, may be a sufficient analgesic to treat most postoperative dental pain. Clinical judgment as to the use of an opioid should include the physiological principles related to the pharmacology of pain and inflammation and may include a central effect. ClinicalTrials.gov Identifier: NCT02929602.

A pilot study of dentists' assessment of caries detection and staging systems applied to early caries: PEARL Network findings.

The International Caries Detection and Assessment System (ICDAS II) and the Caries Classification System (CCS) are caries stage description systems proposed for adoption into clinical practice. This pilot study investigated clinicians' training in and use of these systems for detection of early caries and recommendations for individual tooth treatment. Patient participants (N = 8) with a range of noncavitated lesions (CCS ranks 2 and 4 and ICDAS II ranks 2-4) identified by a team of calibrated examiners were recruited from the New York University College of Dentistry clinic. Eighteen dentists-8 from the Practitioners Engaged in Applied Research and Learning (PEARL) Network and 10 recruited from the Academy of General Dentistry-were randomly assigned to 1 of 3 groups: 5 dentists used only visual-tactile (VT) examination, 7 were trained in the ICDAS II, and 6 were trained in the CCS. Lesion stage for each tooth was determined by the ICDAS II and CCS groups, and recommended treatment was decided by all groups. Teeth were assessed both with and without radiographs. Caries was detected in 92.7% (95% CI, 88%-96%) of the teeth by dentists with CCS training, 88.8% (95% CI, 84%-92%) of the teeth by those with ICDAS II training, and 62.3% (95% CI, 55%-69%) of teeth by the VT group. Web-based training was acceptable to all dentists in the CCS group (6 of 6) but fewer of the dentists in the ICDAS II group (5 of 7). The modified CCS translated clinically to more accurate caries detection, particularly compared to detection by untrained dentists (VT group). Moreover, the CCS was more accepted than was the ICDAS II, but dentists in both groups were open to the application of these systems. Agreement on caries staging requires additional training prior to a larger validation study.

Case Presentations Demonstrating Periodontal Treatment Variation: PEARL Network.

BACKGROUND: Variation in periodontal terminology can affect the diagnosis and treatment plan as assessed by practicing general dentists in the Practitioners Engaged in Applied Research and Learning (PEARL) Network. General dentists participating in the PEARL Network are highly screened, credentialed, and qualified and may not be representative of the general population of dentists. METHODS: Ten randomized case presentations ranging from periodontal health to gingivitis, to mild, moderate, and severe periodontitis were randomly presented to respondents. Descriptive comparisons were made between these diagnosis groups in terms of the treatment recommendations following diagnosis. RESULTS: PEARL practitioners assessing periodontal clinical scenarios were found to either over- or under-diagnose the case presentations, which affected treatment planning, while the remaining responses concurred with respect to the diagnosis. The predominant diagnosis was compared with that assigned by two practicing periodontists. There was variation in treatment based on the diagnosis for gingivitis and the lesser forms of periodontitis. CONCLUSION: Data suggests that a lack of clarity of periodontal terminology affects both diagnosis and treatment planning, and terminology may be improved by having diagnosis codes, which could be used to assess treatment outcomes. CLINICAL IMPLICATIONS: This article provides data to support best practice for the use of diagnosis coding and integration of dentistry with medicine using ICD-10 terminology.

Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network.

A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. The model represents robust clinical data from persons of record allowing for improved interpretation of drug/device side-effects and for regulatory reviewers to expedite the approval process.

Dental hygienists' role in practice based research: PEARL Network evaluation.

PURPOSE: The goal of this paper is to evaluate the PEARL Network's satisfaction with training/support and assess the relationship between practice research coordinators (PRCs) involvement and study participation. METHODS: At the PEARL Network 2011 Annual Meeting, an evaluation form was completed by practitioner-investigators and PRCs who attended the annual meeting. Results from the paper evaluation form were entered into an Excel database, and analyzed using the statistical analysis software SPSS. The bivariate correlation test, Pearson Correlation, was conducted, and results were considered significant if p<0.05. RESULTS: During a program evaluation among 84 network respondents, a positive correlation (p=0.004) was found between the number of PRCs and the number of studies in which a site participates. In addition, there was a positive correlation between satisfaction with the training, support and involvement of PRCs in organizing study activities (p=0.008). There was also positive correlation between satisfaction with training/support and the number of PRCs utilized by the office (p=0.039). CONCLUSION: Practice research coordinators are key members of the research team, and they are important to conducting clinical studies in everyday practice.

Practice based research networks impacting periodontal care: PEARL Initiative.

In 2005, the National Institute of Dental and Craniofacial Research /National Institutes of Health funded the largest initiative to date to affect change in the delivery of oral care. This commentary provides the background for the first study related to periodontics in a Practice Based Research Network (PBRN). It was conducted in the Practitioners Engaged in Applied Research & Learning (PEARL) Network. The PEARL Network is headquartered at New York University College of Dentistry. The basic tenet of the PBRN initiative is to engage clinicians to participate in clinical studies, where they will be more likely to accept the results and to incorporate the findings into their practices. This process may reduce the translational gap that exists between new findings and the time it takes for them to be incorporated into clinical practice. The cornerstone of the PBRN studies is to conduct comparative effectiveness research studies to disseminate findings to the profession and improve care. This is particularly important because the majority of dentists practice independently. Having practitioners generate clinical data allows them to contribute in the process of knowledge development and incorporate the results in their practice to assist in closing the translational gap. With the advent of electronic health systems on the horizon, dentistry may be brought into the mainstream health care paradigm and the PBRN concept can serve as the skeletal framework for advancing the profession provided there is consensus on the terminology used.

Periodontal diagnosis affected by variation in terminology.

BACKGROUND: The randomized case presentation (RCP) study is designed to assess the degree of diagnostic accuracy for described periodontal cases. This is to lay the basis for practitioner calibration in the Practitioners Engaged in Applied Research and Learning (PEARL) Network for future clinical studies. METHODS: The RCP consisted of 10 case scenarios ranging from periodontal health to gingivitis and mild, moderate, and severe periodontitis. Respondents were asked to diagnose the described cases. Survey diagnoses were compared to two existing classifications of periodontal disease status. The RCP was administered via a proprietary electronic data capture system maintained by the PEARL Data Coordinating Center. Standard analytic techniques, including frequency counts and cross-tabulations, were used for categorical data with mean and standard deviation and median values reported for continuous data elements. RESULTS: Demonstrable variations in periodontal assessment for health, gingivitis, and mild, moderate, and severe periodontitis were found among the 130 PEARL general practitioners who participated in the RCP survey. The highest agreement for diagnosis among dentists was for severe periodontitis (88%) and the lowest for gingivitis (55%). The highest percentage of variation was found in cases with health and gingivitis. CONCLUSIONS: There was variation among PEARL practitioners in periodontal diagnosis that may affect treatment outcomes. Our findings add clinical support to recent publications suggesting a need for standardization of terminology in periodontitis diagnosis.

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Dentin caries activity in early occlusal lesions selected to receive operative treatment: findings from the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

BACKGROUND: Members of the practice-based research network Practitioners Engaged in Applied Research and Learning (PEARL) Network investigated the dentin caries activity in early occlusal lesions and its relationship to patient age, preoperative tooth sensitivity and radiographic appearance, as well as its influence on preparation depth and volume. METHODS: PEARL Network practitioner-investigators (P-Is) (n = 45), general dentists who were trained but whose methods were not calibrated, conducted a study regarding postoperative hypersensitivity in resin-based composite restorations. The P-Is enrolled as study participants 613 patients with occlusal carious lesions that, in the P-Is' clinical judgment, required restoration. The P-Is used baseline radiographs to assess the depth and extent of the lesions. Data for 671 restorations included baseline sensitivity; ranking of dentin caries activity on the opening of the enamel; radiographic visibility (n = 652); and measurements of preparation depth, width and length. RESULTS: P-Is found rapidly progressing dentin caries in 38.5 percent (258 of 671) of lesions and slowly progressing (and potentially inactive dentin) caries in the remainder of the lesions. Rapidly progressing caries was not related to the participant's age or participant-reported preoperative hypersensitivity but was related to the lesion depth as seen radiographically (P < .001) and depth (P < .001) and volume (P < .001) of the preparation. Molars had slightly higher but not statistically significant levels of caries activity. CONCLUSION: Rapidly progressing dentin caries, while present in only 38.5 percent of lesions, was related to the lesion's radiographic appearance but not to the participant's age or the study tooth's pre-operative sensitivity. CLINICAL IMPLICATIONS: On the basis of the low level of rapidly progressing dentin caries in this study population and the fact that slowly progressing caries can be inactive or remineralizing, the authors advise sealing versus operative treatment of early or shallow occlusal lesions.

Advantages of the dental practice-based research network initiative and its role in dental education.

Practice-based research networks (PBRNs) provide a novel venue in which providers can increase their knowledge base and improve delivery of care through participation in clinical studies. This article describes some aspects of our experience with a National Institute of Dental and Craniofacial Research-supported PBRN and discusses the role it can play in dental education. PBRNs create a structured pathway for providers to advance their professional development by participating in the process of collecting data through clinical research. This process allows practitioners to contribute to the goals of evidence-based dentistry by helping to provide a foundation of evidence on which to base clinical decisions as opposed to relying on anecdotal evidence. PBRNs strengthen the professional knowledge base by applying the principles of good clinical practice, creating a resource for future dental faculty, training practitioners on best practices, and increasing the responsibility, accountability, and scope of care. PBRNs can be the future pivotal instruments of change in dental education, the use of electronic health record systems, diagnostic codes, and the role of comparative effectiveness research, which can create an unprecedented opportunity for the dental profession to advance and be integrated into the health care system.