Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial.

BACKGROUND: This double-masked, parallel-design, clinical trial assessed whether a combination nasal spray (K305; 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride) compared with a tetracaine-only spray and a placebo spray would be safer and superior in producing local anesthesia sufficient to complete a direct restorative procedure in maxillary nonmolar teeth. METHODS: The authors randomized eligible patients to receive K305 spray (n = 44), tetracaine hydrochloride spray (n = 44), or a placebo solution (n = 22). The authors compared the incidence of the primary efficacy end point-completion of the procedure without rescue local anesthetic-by means of a 1-tailed Fisher exact test. RESULTS: The end point incidence was 84.1% (95% confidence interval [CI], 69.9-93.4) with K305, 27.3% (95% CI, 15.0-42.8) with tetracaine only, and 27.3% (95% CI, 10.7-50.2) with placebo (P < .001 for K305 versus tetracaine only and versus placebo). Combination spray was associated with statistically significant but transient increases in blood pressure. The most frequent adverse events were rhinorrhea and nasal congestion, which resolved within 2 hours after treatment and occurred more often in the K305 group and tetracaine-only group. CONCLUSIONS: In this study population, the K305 combination nasal spray was safe and more effective in attaining pulpal anesthesia of maxillary teeth from premolar to premolar compared with tetracaine-only and placebo sprays. PRACTICAL IMPLICATIONS: The combination nasal spray might represent a valuable alternative to injected local anesthetic for patients undergoing invasive maxillary dental procedures. Clinicaltrials.gov: NCT01710787.

Building on the proceedings of the McGill conference: implant-retained overdentures in an area of South America.

PURPOSE: Since the McGill consensus conference, numerous reports have proposed the advantages of the 2-implant-retained overdenture over the conventional denture in the restorative management of the edentulous mandible. The purpose of this article was to demonstrate the use of the 2-implant-retained overdenture in the restorative management of patients with edentulous mandibles in an impoverished population. MATERIALS: To address the study's purpose, the investigators initiated a retrospective cohort study and enrolled a sample of subjects who had mandibular 2-implant overdenture treatment using the protocol described within. The primary predictor variable was whether the patient had mandibular 2-implant overdenture treatment. The primary outcome variable was survival of mandibular 2-implantoverdenture treatment as defined within. RESULTS: The study sample included 35 patients each of whom had 2 mandibular implants placed for a total of 70 implants inserted with the purpose of retaining a mandibular overdenture. The mean clinical follow-up time was 74.7 months, during which there were no incidences of implant failure. Therefore, analytical and survival analyses could not be performed. CONCLUSION: Given the increase in quality of life and ease in implementation, clinicians should now be suggesting the mandibular 2-implant overdenture as the treatment of choice in the management of the edentulous mandible.