Abstract
BACKGROUND: This study aimed to evaluate the efficacy and safety of dentin hypersensitivity (DH) treatment using a newly developed device based on a powder jet deposition (PJD) technique that creates a hydroxyapatite (HAP) layer on the dentin surface, thereby alleviating the hypersensitivity. The effect of the PJD treatment was compared with that of conventional treatment using Teethmate Desensitizer (TMD; calcium-phosphate containing material with TTCP (Ca(4)(PO(4))(2)O) and DCPA (CaHPO(4))), which has been used clinically in Japan with well-confirmed effectiveness. MATERIALS AND METHODS: A randomized controlled trial was conducted including 35 patients who had symptoms of DH in two or more quadrants. Two test teeth were selected per patient (70 teeth in total) and randomly assigned to PJD or TMD treatment. The efficacy was evaluated using the improvement rate for air and scratch pain according to the scores obtained via visual analog scale 12 weeks after treatment. The safety assessment was performed focusing on gingival index (GI) and spontaneous pain. The t-test was used to analyze the non-inferiority of PJD treatment compared to TMD treatment. RESULTS: The improvement rate of air pain was 69.0% for PJD and 69.7% for TMD. The improvement rate of scratch pain was 80.8% for PJD and 81.7% for TMD. Non-inferiority with a margin of 10% was not observed for both air and scratch pain. No change was observed in GI from baseline and the improvement rate of spontaneous pain for PJD was higher than that for TMD. CONCLUSION: Non-inferiority of PJD to TMD treatment was not observed in this study; however, it was not statistically demonstrated, and the results were thus interpreted as inconclusive. PJD did improve the DH symptoms, as did TMD. PJD's therapeutic effect was most likely attributable to the deposition of a HAP layer on the tooth surface, which would alleviate hypersensitivity for at least 12 weeks without causing severe adverse events. TRIAL REGISTRATION: UMIN-CTR. ID: UMIN000025022. date: 02/12/2016.