title: In-practice evaluation of OraVerse for the reversal of soft-tissue anesthesia after dental procedures.
abstract: This study investigated the pattern of use, dentist evaluation, and patient assessment of OraVerse (OV), a solution of phentolamine mesylate formulated for intraoral submucosal injection and used for the reversal of soft anesthesia after dental procedures. Participants were provided the drug for treatment of up to 10 patients each and agreed to complete a 26-item evaluation questionnaire at the end of the clinical assessment. Data were available from 51 dentists reporting on 390 patients 4 to 90 years of age. A total of 394 dental procedures were performed: 224 (57%) in the mandible and 170 (43%) in the maxilla. Local anesthetics most frequently used were lidocaine/epinephrine (66.4%) and articaine/epinephrine (23.6%). In 81.5% of cases, OV was administered after restorative procedures. This OV dose was given as one-half, one, and two cartridges in 11.8%, 76.7%, and 10.3% of patients, respectively. An adverse reaction at the injection site was reported in 19 patients (4.9%). The median times to return to normal after injection were 60 minutes for lip sensation, 57.5 minutes for tongue sensation, and 60 minutes for oral function. Patients reported reduced duration of oral numbness (92%) and improved dental experiences (84%) after use. A total of 83% of patients said they would recommend the medication to others and 79% said they would opt for OV in the future. Dentists reported that the medication addressed an existing need (86%), met expectations (82%), was a practice differentiator (55%) and a practice builder (45%), and improved scheduling (29%). In this in-practice clinical evaluation, times to return to normal oral sensation and function after OV administration were consistent with those reported in randomized clinical studies. Both patient and dentist satisfaction rates were high.
authors.affiliation: Department of Restorative Sciences, Herman Ostrow School of Dentistry of the University of Southern California, Los Angeles, California, USA.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Saunders
authors.forename: Gregory
authors.initials: G
authors.lastname: Psaltis
authors.forename: John F
authors.initials: JF
authors.lastname: Weston
authors.forename: Rex R
authors.initials: RR
authors.lastname: Yanase
authors.forename: Siegfried S
authors.initials: SS
authors.lastname: Rogy
authors.forename: Richard G
authors.initials: RG
authors.lastname: Ghalie
mesh_terms: D000293:Adolescent; D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000766:Anesthesia, Dental; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000037:antagonists & inhibitors*; D002355:Carticaine / Q000008:administration & dosage / Q000037:antagonists & inhibitors; D002648:Child; D002675:Child, Preschool; D004837:Epinephrine / Q000008:administration & dosage; D006801:Humans; D007267:Injections / Q000009:adverse effects; D008012:Lidocaine / Q000008:administration & dosage / Q000037:antagonists & inhibitors; D008046:Lip / Q000187:drug effects; D008875:Middle Aged; D017060:Patient Satisfaction; D010646:Phentolamine / Q000627:therapeutic use*; D019239:Practice Patterns, Dentists'; D020127:Recovery of Function / Q000187:drug effects; D012677:Sensation / Q000187:drug effects; D013997:Time Factors; D014059:Tongue / Q000187:drug effects; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D000317:Adrenergic alpha-Antagonists; D000779:Anesthetics, Local; D014662:Vasoconstrictor Agents; D008012:Lidocaine; D002355:Carticaine; D004837:Epinephrine; D010646:Phentolamine