title: Safety and efficacy of a novel nasal spray for maxillary dental anesthesia.
abstract: This study examines the efficacy, safety, and tolerability of a nasal spray to induce anesthesia of maxillary teeth. Forty-five healthy adults requiring restoration of one maxillary tooth were randomized in a 1:2 ratio to receive (1) an intra-oral lidocaine-epinephrine injection with buffered saline nasal spray bilaterally, or (2) a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection. Primary endpoints were use of rescue anesthesia and patient global pain assessment. Secondary outcomes included vital sign changes, soft-tissue anesthesia, and treatment-emergent adverse events. In intent-to-treat analysis, 25 of 30 patients given nasal spray (83.3%) did not require rescue anesthesia. Proportion of anesthesia successes for nasal spray was significantly different from the hypothesized placebo anesthesia success of 30% (one-sided p value < .0001 by exact binomial test). Mean duration of soft-tissue anesthesia did not differ significantly by treatment for 3 of 4 sites assessed. No serious adverse events or systemic effects were observed. Tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia for the majority of maxillary dental procedures. Based on the results from this Phase 2 study, pivotal trials are warranted to validate these findings in an expanded patient population.
authors.affiliation: Department of Periodontics and Endodontics, 250 Squire Hall, University at Buffalo, Buffalo, NY, USA. ciancio@buffalo.edu
authors.forename: S G
authors.initials: SG
authors.lastname: Ciancio
authors.forename: M C
authors.initials: MC
authors.lastname: Hutcheson
authors.forename: F
authors.initials: F
authors.lastname: Ayoub
authors.forename: E A
authors.initials: EA
authors.lastname: Pantera
authors.forename: C T
authors.initials: CT
authors.lastname: Pantera
authors.forename: D A
authors.initials: DA
authors.lastname: Garlapo
authors.forename: B D
authors.initials: BD
authors.lastname: Sobieraj
authors.forename: S A
authors.initials: SA
authors.lastname: Almubarak
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D000766:Anesthesia, Dental / Q000379:methods*; D000779:Anesthetics, Local / Q000008:administration & dosage*; D004311:Double-Blind Method; D004837:Epinephrine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007267:Injections; D008012:Lidocaine / Q000008:administration & dosage; D008297:Male; D008437:Maxilla / Q000294:innervation*; D008875:Middle Aged; D059085:Nasal Sprays; D010109:Oxymetazoline / Q000008:administration & dosage; D010147:Pain Measurement; D010919:Placebos; D012449:Safety; D013748:Tetracaine / Q000008:administration & dosage; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage; D055986:Vital Signs / Q000187:drug effects; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D059085:Nasal Sprays; D010919:Placebos; D014662:Vasoconstrictor Agents; D013748:Tetracaine; D010109:Oxymetazoline; D008012:Lidocaine; D004837:Epinephrine
keywords: drug delivery system; drug evaluation; local anesthetic; permanent dental filling; phase 2 clinical trial