An international consensus study to identify "what" outcomes should be included in a core outcome set for endodontic treatments (COSET) for utilization in clinical practice and research.

BACKGROUND: Development of a standardized set of topic-specific outcomes known as a Core Outcome Set (COS) is important to address issues of heterogeneity in reporting research findings in order to streamline evidence synthesis and clinical decision making. AIM: The aim of the current international consensus study is to identify "what" outcomes to include in the Core Outcome Set for Endodontic Treatments (COSET). Outcomes of various endodontic treatments (non-surgical root canal treatment, surgical endodontics, vital pulp treatment and revitalization procedures) performed on permanent teeth were considered. METHODS: A standard validated methodology for COS development and reporting was adopted. The process involved identification of existing outcomes through four published scoping reviews. This enabled creation of a list of outcomes to be prioritized via semi-structured patient interviews, e-Delphi process and a consensus meeting with a range of relevant global stakeholders. Outcomes were prioritized using a 1-9 Likert scale, with outcomes rated 7-9 considered critical, 4-6 are important and 1-3 are less important. Outcomes rated 7-9 by ≥70% and 1-3 by <15% of participants were considered to achieve consensus for inclusion in the COS. The outcomes that did not achieve consensus in the first round were considered for further prioritization in the second Delphi round and consensus meeting. Final decisions about the outcomes to include in COSET were made by voting during the consensus panel meeting using the Zoom Poll function. RESULTS: A total of 95 participants including patients contributed to the COS development process. The consensus panel recommended, with strong consensus, eight outcomes shared across all treatment modalities for inclusion in COSET: pain; signs of infection (swelling, sinus tract); further intervention/exacerbation; tenderness to percussion/palpation; radiographic evidence of disease progression/healing; function; tooth survival; and patient satisfaction. Additional treatment specific outcomes were also recommended. DISCUSSION: Many of the outcomes included in COSET are patient reported. All should be included in future outcomes studies. CONCLUSION: COSET identified outcomes that are important for patients and clinicians and validated these using a rigorous methodology. Further work is ongoing to determine "how" and "when" these outcomes should be measured.

Treatment of pulpal and apical disease: The European Society of Endodontology (ESE) S3-level clinical practice guideline.

BACKGROUND: The ESE previously published quality guidelines for endodontic treatment in 2006; however, there have been significant changes since not only in clinical endodontics but also in consensus and guideline development processes. In the development of the inaugural S3-level clinical practice guidelines (CPG), a comprehensive systematic and methodologically robust guideline consultation process was followed in order to produce evidence-based recommendations for the management of patients presenting with pulpal and apical disease. AIM: To develop an S3-level CPG for the treatment of pulpal and apical disease, focusing on diagnosis and the implementation of the treatment approaches required to manage patients presenting with pulpitis and apical periodontitis (AP) with the ultimate goal of preventing tooth loss. METHODS: This S3-level CPG was developed by the ESE, with the assistance of independent methodological guidance provided by the Association of Scientific Medical Societies in Germany and utilizing the GRADE process. A robust, rigorous and transparent process included the analysis of relevant comparative research in 14 specifically commissioned systematic reviews, prior to evaluation of the quality and strength of evidence, the formulation of specific evidence and expert-based recommendations in a structured consensus process with leading endodontic experts and a broad base of external stakeholders. RESULTS: The S3-level CPG for the treatment of pulpal and apical disease describes in a series of clinical recommendations the effectiveness of diagnosing pulpitis and AP, prior to investigating the effectiveness of endodontic treatments in managing those diseases. Therapeutic strategies include the effectiveness of deep caries management in cases with, and without, spontaneous pain and pulp exposure, vital versus nonvital teeth, the effectiveness of root canal instrumentation, irrigation, dressing, root canal filling materials and adjunct intracanal procedures in the management of AP. Prior to treatment planning, the critical importance of history and case evaluation, aseptic techniques, appropriate training and re-evaluations during and after treatment is stressed. CONCLUSION: The first S3-level CPG in endodontics informs clinical practice, health systems, policymakers, other stakeholders and patients on the available and most effective treatments to manage patients with pulpitis and AP in order to preserve teeth over a patient's lifetime, according to the best comparative evidence currently available.

Critical analysis of research methods and experimental models to study removal of root filling materials.

Despite enjoying high favourable outcome rates, root canal treatment is not always successful. Root canal retreatment is a widely practised option for managing a non-healing root treated tooth. A basic distinction between retreatment and initial treatment is the requirement to remove the existing root filling material occupying the root canal space. Only then, can the technical deficiencies and possible causes of failure be addressed. Hence, the successful removal of the root filling material is critical to achieving the objectives of retreatment. Many different materials and techniques have been used for root canal filling, which have been documented in a plethora of studies; these are mainly laboratory studies investigating the removal of root filling materials. To help guide future research, which may then better inform clinical practice in relation to retreatment procedures, the focus of this narrative review is on the research methods and experimental models employed to study the removal of root filling materials. The current available literature demonstrates great variation in the research methodologies used to study the removal of root filling material, including direct visualization by splitting tooth samples or clearing, three-dimensional radiographic imaging including using microcomputed tomography or cone-beam computed tomography, and a combination of these techniques. Depending on the research method employed, variation also exists in quantification of root filling material removal; these include measurements of surface area, volume or weight, and criteria-based (semi-quantitative) assessment. Experimental models, using human teeth or resin models, differ with respect to standardization techniques and replication of the clinical scenario including initial sample preparation, canal filling, allocation and technical aspects of retreatment procedures. Future models should replicate, as closely as possible, the clinical scenario. Currently, microcomputed tomography provides a highly detailed, non-invasive and non-destructive method of objectively assessing and quantifying root filling removal.

Outcomes reporting in systematic reviews on surgical endodontics: A scoping review for the development of a core outcome set.

BACKGROUND: Evidence-informed decision-making in health care relies on the translation of research results to everyday clinical practice. A fundamental requirement is that the validity of any healthcare intervention must be supported by the resultant favourable treatment outcome. Unfortunately, differences in study design and the outcome measures evaluated often make it challenging to synthesize the available research evidence required for secondary research analysis and guideline development. Core outcome sets (COS) are defined as an agreed standardized set of outcomes, which should be measured and reported as a minimum in all clinical trials on a specific topic. The benefits of COS include less heterogeneity, a reduction in the risk of reporting bias and ensuring all trials contribute data to facilitate meta-analyses; given the engagement of key stakeholders, it also increases the chances that clinically relevant outcomes are identified. The recognition of the need for COS for assessing endodontic treatment outcomes leads to the development of Core Outcome Sets for Endodontic Treatment modalities (COSET) protocol, which is registered (No. 1879) on the Core Outcome Measures in Effectiveness Trials (COMET) website. OBJECTIVES: The objectives of this scoping review are to: (1) identify the outcomes assessed in studies evaluating surgical endodontic procedures; (2) report on the method of assessment used to measure the outcomes; (3) and assess selective reporting bias in the included studies. The data obtained will be used to inform the development of COS for surgical endodontics. METHODS: A structured literature search of electronic databases and the grey literature was conducted to identify systematic reviews on periradicular surgery (PS), intentional replantation (IR) and tooth/root resection (RR), published between January 1990 and December 2020. Two independent reviewers were involved in the literature selection, data extraction and the appraisal of the studies identified. The type of intervention, outcomes measured, type of outcomes reported (clinician- or patient-reported), outcome measurement method and follow-up period were recorded using a standardized form. RESULTS: Twenty-six systematic reviews consisting of 19 studies for PS, three studies for IR and four studies for RR were selected for inclusion. Outcome measures identified for PS and IR included pain, swelling, mobility and tenderness, outcomes related to periodontal/soft tissue healing (including sinus tract), periradicular healing, tooth survival, life impact (including oral health-related quality of life), resource use and/or adverse effects. For RR, in addition to tooth survival, endodontic complications and adverse effects, the outcome measures were primarily periodontal-related, including pocket depth reduction, attachment gain, periodontal disease and periodontic-endodontic lesions. The majority of outcome measures for PS, IR and RR were assessed clinically, radiologically and/or via patient history. Specific tools such as rating scales (Visual Analog Scale, Verbal Rating Scale, Numerical Rating Scale and other scales) were used for the assessment of pain, swelling and tenderness, and validated questionnaires were used for the assessment of oral health-related quality of life. The range of follow-up periods was variable, dependent on the outcome measure and the type of intervention. CONCLUSIONS: Outcome measures, method of assessment and follow-up periods for PS, IR and RR were identified and categorized to help standardize the reporting of outcomes for future research studies. Additional outcome measures that were not reported, but may be considered in the COSET consensus process, include loss of root-end filling material, number of clinic visits, surgery-related dental anxiety and mucogingival aesthetic-related measures, such as scarring, black triangles, root surface exposure and tissue discoloration. REGISTRATION: COMET (No. 1879).

Anatomical relationship between mental foramen, mandibular teeth and risk of nerve injury with endodontic treatment.

OBJECTIVES: The objective of the present study was to evaluate the anatomical relationship between mental foramen (MF), including the incidence of the anterior loop of the inferior alveolar nerve (AL), and roots of mandibular teeth in relation to risk of nerve injury with endodontic treatment. MATERIALS AND METHODS: Cone-beam computed tomography (CBCT) images, which included teeth either side of the MF, were randomly selected. The anonymised CBCT images were reconstructed and examined in coronal, axial and sagittal planes, using three-dimensional viewing software, to determine the relationship and distance between MF and adjacent mandibular teeth. The actual distance between the root apex and MF was calculated mathematically using Pythagoras' theorem. If present, the incidence of an AL in the axial plane was also recorded. RESULTS: The root apex of the mandibular second premolar (70 %), followed by the first premolar (18 %) and then the first molar (12 %), was the closest to the MF. Ninety-six percent of root apices evaluated were >3 mm from the MF. An AL was present in 88 % of the cases. CONCLUSIONS: With regards to endodontic treatment, the risk of nerve injury in the vicinity of the MF would appear to be low. However, the high incidence of the AL highlights the need for clinicians to be aware and careful of this important anatomical feature. CLINICAL RELEVANCE: The risk of injury to the MN with endodontic treatment would appear to be low, but given the high incidence, it is important to be aware and be careful of the AL.

The Effect of Glide Path Preparation on Root Canal Shaping Procedures and Outcomes.

The 'glide path' in non-surgical root canal treatment refers to a smooth radicular tunnel from the root canal orifice to its terminus. Its establishment is aimed at creating sufficient space to facilitate the subsequent and safer use of engine-driven nickel titanium (NiTi) shaping files. Glide paths were originally prepared using stainless steel hand files to, at least, a loose International Organisation for Standardisation (ISO) size 10 or larger. However, the advent of engine-driven NiTi instrumentation has led to the availability of many engine-driven NiTi glide path files. The aims of this review were to assess the effects of engine-driven and manual glide path preparation (GPP) on root canal shaping procedures and outcomes. An online search of the PubMed, Embase, Scopus and ScienceDirect databases was conducted and 32 studies were identified. The published literature suggests the use of engine-driven glide path files to be beneficial in maintaining the original root canal anatomy, reducing preparation time, decreasing apical extrusion of debris and causing less postoperative pain. However, there was no difference between engine-driven and manual GPP with regards to the physical strain exerted on the shaping files. Future research focused on clinical outcomes is needed to help ascertain the clinical benefits for patients.

Computer-aided dynamic navigation: a novel method for guided endodontics.

OBJECTIVES: To investigate the novel use of computer-aided dynamic navigation for guided endodontics. METHOD AND MATERIALS: Dental casts were fabricated from sets of extracted human teeth. A cone beam computed tomography (CBCT) scan of each cast, with a molded thermoplastic stent and a radiographic marker attached, was obtained and imported into the planning software of a dynamic navigation implant surgery system. Simulating implant surgery but for guided endodontics, the drilling entry point, angle, pathway, and depth of virtual implants were planned for 29 selected teeth. The radiographic marker was replaced with a jaw tag and mounted in a phantom head. A drill tag was attached to the drill handpiece. Following calibration, guided by the stereoscopic motion-tracking camera via the tags and images on a computer monitor providing real-time dynamic plus visual intraoperative feedback, the handpiece was aligned accordingly and endodontic access cavity preparation carried out. Successful root canal location was confirmed using periapical radiographs and CBCT. RESULTS: Conservative access cavities were achieved and all the expected canals were successfully located in 26 teeth (n = 29). Due to tracking difficulties, only one canal was located in two maxillary second molars; in a maxillary first molar, only two canals were located and the access preparation for the third canal was misaligned and off-target. CONCLUSIONS: The results of this study demonstrate the potential of using computer-aided dynamic navigation technology in guided endodontics in clinical practice.

Factors Associated with Apical Periodontitis: A Multilevel Analysis.

INTRODUCTION: Ignoring the cluster effect is a common statistical oversight that is also observed in endodontic research. The aim of this study was to explore the use of multilevel modeling in investigating the effect of tooth-level and patient-level factors on apical periodontitis (AP). METHODS: A random sample of digital panoramic radiographs from the database of a dental hospital was evaluated. Two calibrated examiners (κ ≥ 0.89) assessed the technical quality of the root fillings and the radiographic periapical health status by using the periapical index. Descriptive statistical analysis was carried out, followed by multilevel modeling by using tooth-level and patient-level predictors. Model fit information was obtained, and the findings of the best-fit model were reported. RESULTS: A total of 6409 teeth were included in the analysis. The predicted probability of a tooth having AP was 0.42%. There was a statistically significant variability between patients (P < .05). Approximately 53.16% of the variability was accounted for by the patients, leaving 46.84% of the variability to teeth or other factors. Posterior tooth, inadequate root filling, and age were found to be significantly associated with AP (P < .05). CONCLUSIONS: Multilevel modeling is a valid and efficient statistical method in analyzing AP data. The predicted probability of a tooth having AP was generally small, but there was great variation between individuals. Posterior teeth and those with poor quality root filling were found to be more frequently associated with AP. On the patient level, advancing age was a factor significantly associated with AP.

Postoperative pain after root-end resection and filling.

OBJECTIVE: To evaluate the pain experience following root-end resection and filling with Mineral Trioxide Aggregate or Intermediate Restorative Material. STUDY DESIGN: Referred adult patients recruited using strict entry criteria were randomly allocated to receive either material. A standardized surgical technique was employed. Postoperative instructions and a pain questionnaire were given to each patient to record the severity of their pain at 3 time intervals-3-5 hours, 24 hours, and 48 hours after surgery-on a standard visual analog scale (VAS). Patients were also asked to record consumption of any self-prescribed analgesics, the type, and dosage. RESULTS: At 3-5 hours after surgery, regardless of the material used, 90% of all patients experienced some level of postoperative pain. Twenty-four hours after surgery 82% of patients experienced pain, as did 72% after 48 hours. Thirty-seven percent of patients did not take any analgesics at all. In order of popularity, the analgesics taken were ibuprofen, acetaminophen, and acetaminophen plus codeine phosphate. The VAS measurements were reduced over time in both treatment groups (P < .001). There was no statistically significant difference in the proportion of subjects taking analgesics in each treatment group. Patients who used analgesics showed higher median VAS measurements at all time periods (P < .05). CONCLUSIONS: There was no significant difference in the pain experienced by both treatment groups. The postoperative pain was of a relatively short duration, at its maximum intensity early in the postoperative period but progressively decreased with time. Even if pain relief medication was needed, nonprescription analgesics were adequate and effective.