Safety and efficacy of a novel nasal spray for maxillary dental anesthesia.

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.

Clinical effectiveness and soft tissue compatibility of a temporary restorative material.

OBJECTIVE: The purpose of this six-week study was to evaluate in vivo the effectiveness of Systemp.inlay as a temporary restorative material. METHOD: Subjects with the proper indication for a class II restoration were entered into the study. Twenty-three subjects and twenty-nine temporary restorations were evaluated at time of placement, three and six weeks. Two faculty members were calibrated to evaluate the material. Following the six-week trial, the temporary restorative material was removed and the test teeth were restored with a definitive restorative material. RESULTS: The temporary restorative material provided mechanical and anticariogenic protection of tooth structure while preventing dental sensitivity and patient discomfort. It promoted soft tissue health as evidenced by the enhanced plaque and gingival indices found associated with the temporarily restored teeth. Its ease of placement and removal makes it an attractive alternative for the dental practitioner. The change in color of the material over the six-week duration of the study may limit its use to posterior teeth and to lingual/palatal surfaces of anterior teeth. CONCLUSION: Ease of placement and removal and retention of the temporary restorative material were extremely good. Marginal and surface integrity of the material was maintained and no or minimal sensitivity was reported throughout the study. The material did not promote the accumulation of plaque nor result in gingival inflammation. The color change noted was not of clinical importance. Therefore, this temporary restorative material was demonstrated to be clinically effective in Class II cavity preparations.