In-practice evaluation of OraVerse for the reversal of soft-tissue anesthesia after dental procedures.

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.

The use of phentolamine mesylate to evaluate mandibular nerve damage following implant placement.

High success rates and long-term predictability of implant therapy have been well documented in the literature. However, complications in implant treatment can arise and include sensory disturbances, especially in the posterior mandible in areas close to the inferior alveolar nerve. Treatment efficacy of sensory disturbances caused by implant placement in this area relies on the expeditious diagnosis of an induced paresthesia. Recently, phentolamine mesylate has been introduced as a reversal agent of local anesthesia with the ability to decrease the requisite time for a patient to return to normal sensation. This article introduces a method for faster detection of a potential paresthesia induced by implant placement in the posterior mandible.

Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults.

BACKGROUND: The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures. METHODS: On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. RESULTS: Median recovery times in the lower lip and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant (P < .0001). Recovery from actual functional deficits and subject-perceived altered function, sensation and appearance also showed significant differences between the PM and the sham groups. CONCLUSIONS: PM was efficacious and safe in reducing the duration of local anesthetic- induced soft-tissue numbness and its associated functional deficits. CLINICAL IMPLICATIONS: Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.