Abstract
Objective
To assess the anesthetic efficacy of articaine with the needle-free/Comfort-in™ method compared to the conventional needle method. To assess pain during anesthesia application, onset of anesthesia and patient`s self-reported quality of life-related to oral health after the dental emergency appointment.
Materials and methods
This parallel, randomized clinical trial was conducted by a single operator/dentist in the state of Maranhao, northeast of Brazil. Included participants were adult dental patients with one molar (maxillary) or premolar (maxillary or mandibular) tooth diagnosed with symptomatic irreversible pulpitis. The primary outcome was the anesthetic efficacy, measured using a combination of electrical and cold pulp tests (cold + EPT) and the Numerical Rating Scale (NRS). Secondary outcomes were pain during anesthesia application, onset of anesthesia, and patient`s quality-of-life (measured with the OHIP-14).
Results
62 patients were randomized in the anesthesia needle-free group and Comfort-in group (34.26 ± 10.786 × 33.29 ± 8.399 years old, respectively). The group of patients in the Comfort-in group had 71.0% success. Patients from the Comfort-in group reported statistically lower pain during the anesthesia application than patients from the conventional group (2.13 ± 2.172 × 6.03 ± 3.146 NRS scores, respectively) as well as immediately after the anesthetic procedure. Patients self-reported negative impact in quality of life was similar between groups before (p > 0.05) and after (p > 0.05) the dental emergency.
Conclusions
Comfort-in™ had similar efficacy to the conventional needle method.
Clinical relevance
This trial showed that it is possible to anesthetize patients with tooth pulpits without using needles to provide comfort mainly to anxious patients.
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Data availability
All the research data used in this manuscript will be available whenever requested.
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Funding
This research was funded by Foundation for the Support of Scientific and Technological Research of Maranhão, grant number FAPEMA EDITAL BM-01425/20 and FAPEMA UNIVERSAL-00944/18.
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Conceptualization, C.N.C., C.C.R.M.; methodology, A.P.A.N, E.M.F., C.P.C.; validation, M.C.F, G.G; formal analysis, C.N.C; investigation, A.P.A.N, B.L.L.S.;, resources, C.N.C; G.G; data curation, M.C.F; writing—original draft preparation, A.P.A.N, C.N.C., C.C.R.M.; writing—review and editing, M.C.F, R.G.S.; supervision, C.N.C; project administration, C.N.C; funding acquisition, C.N.C. All authors have read and agreed to the published version of the manuscript.
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Ethical approval for the trial protocol was obtained from the CEUMA University Research Ethics Committee (#4,776,212) and was registered in REBEC (RBR-107dyj7w).
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All individual participants provided written and signed informed consent.
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Nogueira, A.P.A., Ferreira, M.C., MAIA, C. et al. Efficacy of articaine anesthesia with needle-free/Comfort-in method and conventional needle injection in dental patients with irreversible pulpitis: a randomized clinical trial. Clin Oral Invest 28, 205 (2024). https://doi.org/10.1007/s00784-024-05582-w
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DOI: https://doi.org/10.1007/s00784-024-05582-w