The importance of establishing a core outcome set for endodontic clinical trials and outcomes studies

AimTo investigate the association of various pre‐, intra‐ and post‐operative factors on root canal treatment outcome.MethodologyIn this cohort study, primary or secondary root canal treatment of mature permanent teeth was performed by a single endodontist in a private practice over 13 years, and followed 1–4 years after treatment. Treatment details and clinical and radiographic data were collected. The proportion of successfully treated teeth and roots based on strict radiographic (periapical index (PAI) ≤2) and clinical criteria (absence of pain, swelling or sinus tract) was estimated. To evaluate joint associations of prognostic factors and treatment success probability, 44 pre, intra‐ and post‐operative factors were investigated using bivariate associations, and a multiple logistic regression model was fitted using Generalized Estimating Equations.Results1259 teeth (2445 roots, 3149 canals) were assessed with a recall rate of 91%. The proportion of successfully treated teeth was 79.9% [95% confidence interval 77.7–82.1]. Eleven prognostic factors were identified that significantly reduced the odds ratio (OR) for treatment success at tooth level. Six were preoperative: injury history (OR = 0.05[0.01–0.24]), root PAI (OR = 0.29[0.20–0.42], 0.21[0.13–0.34] and 0.22[0.12–0.42] for PAI = 3, 4 and 5, respectively, against PAI = 1), lesion diameter (OR = 0.30[0.21–0.43] and 0.24[0.16–0.37] for diameters of 1‐5 mm and ≥6 mm, respectively, against no lesion), tooth type (OR = 0.51[0.27–0.97] and OR = 0.45[0.24–0.83] for premolars and molars, respectively, against incisors or canines), tenderness to periapical palpation (OR = 0.64[0.43–0.94]) and two canals per root (OR = 0.67[0.54–0.83]). Four factors were intraoperative: root filling of unsatisfactory quality (OR = 0.18[0.08–0.40]) or extending beyond or shorter than 2 mm from the apex (OR = 0.44[0.26–0.75] and 0.62[0.40–0.97] respectively), resin sealer (OR = 0.58[0.39–0.87] against bioceramic sealer) and single visit treatment (OR = 0.40[0.21–0.75] against multiple visits). One factor was post‐operative: defective coronal restoration (OR = 0.35[0.21–0.56]).ConclusionThe following factors were associated with unsuccessful root canal treatment: (i) history of injury, apical periodontitis with increased severity (larger lesion, higher PAI, tenderness to periapical palpation), or complicated anatomic conditions (premolar or molar, two canals in a single root); (ii) technically suboptimal root filling (of unsatisfactory quality or not ending within 2 mm of radiographic apex) performed in a single‐visit, or use of resin sealer instead of novel bioceramic sealer; (iii) suboptimal quality coronal restoration.

Section: Discussionmentioning

confidence: 99%

Factors associated with the outcome of root canal treatment—A cohort study conducted in a private practice

Jurič,

Vidmar,

Blagus

et al. 2024

“…Determining a Core Outcome Set (COS), that is, ‘an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care’ is recommended (COMET initiative, 2023). Several projects are in the making to propose COSs within dental research, including endodontics (Duncan et al., 2021; El‐Karim et al., 2023; Levey et al., 2017; Watson et al., 2020). Hopefully, such recommendations can also serve as a help and reminder for researchers to evaluate outcomes related to patients or society when possible.…”

Section: Discussionmentioning

confidence: 99%

A critical look at outcome measures: Comparison between four dental research journals by use of a hierarchical model

Wrangstål,

Pigg,

Almutairi

et al. 2023

AimTo assess the status quo of outcome measures used in treatment studies in Endodontics, and potentially identify strategies for improvement, by (i) systematically assessing the outcome measures using a conceptual model and (ii) comparing these with measures used in corresponding studies in the adjacent fields.MethodologyThe International Endodontic Journal, Caries Research, The Journal of Clinical Periodontology and The Journal of Oral & Facial Pain and Headache were selected to cover four adjacent dental disciplines. In each journal, the 50 most recent consecutive publications fulfilling inclusion criteria were included. A hierarchical model for diagnostic imaging studies was modified to assess studies related to treatment. The model comprised six levels, with technical as the lowest level and societal as the highest. Extracted data included study origin, study type, and identified outcome measures. Fisher's Exact Tests with Bonferroni corrections compared studies. p < .05 was considered statistically significant.ResultsAmongst 756 publications, the 200 most recent studies matching the inclusion criteria were identified. Less than half (36.5%) assessed the clinical, patient, or societal aspects of treatment; 10.0% in International Endodontic Journal, 28.0% in Caries Research, 38.0% in Journal of Clinical Periodontology, and 70.0% in Journal of Oral & Facial Pain and Headache (p < .001).ConclusionsAccording to included publications, research on treatment within the endodontic field is mainly focusing on technical and biological outcomes. The benefits of patients and society were less frequently examined than in corresponding journals in adjacent disciplines. When designing studies, including higher‐level outcomes should be considered.

“…An a priori protocol for the COSET project was published and registered in COMET (https://comet-initiative.org/Studies/Details/1879) (El Karim et al., 2021, 2022, 2023). This report is prepared according to the Core Outcome Set–STAndards for Reporting (COS‐STAR) Statement (Kirkham et al., 2016).…”

Section: Methodsmentioning

confidence: 99%

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

El Karim,

Duncan,

Cushley

et al. 2023

Self Cite

BackgroundDevelopment 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.AimThe 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.MethodsA 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.ResultsA 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.DiscussionMany of the outcomes included in COSET are patient reported. All should be included in future outcomes studies.ConclusionCOSET 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.