Background Recently, a novel zinc-containing desensitizer, CAREDYNE Shield, was developed. This new type of desensitizer induces chemical occlusion of dentinal tubules for desensitization and releases zinc ion for root caries prevention. Despite these features, its clinical effectiveness in the improvement of cervical dentine hypersensitivity remains to be elucidated. Thus, we aimed to evaluate the effectiveness of CAREDYNE Shield in patients with CDH. Methods Forty CDH teeth which matched the eligibility criteria were randomly allocated to two groups in a 1:1 ratio: the CAREDYNE Shield group (intervention group) and the Nanoseal group (control group). The pain intensity in response to air stimuli, gingival condition, and oral hygiene status of CDH teeth were assessed before and at 4 weeks after treatment. The primary outcome was the reduction of pain intensity in response to air stimuli from baseline to 4 weeks after intervention. Results From November 2019 to April 2021, 24 participants with 40 teeth were enrolled in this study and 33 teeth in 20 participants were assessed at 4 weeks after treatment. A significant reduction of pain in response to air stimuli was observed in both groups; however, no significant difference was observed between the groups. Conclusions This study showed that CAREDYNE Shield is effective for CDH and its effectiveness is similar to Nanoseal. Trial registration UMIN Clinical Trials Registry (UMIN-CTR), UMIN000038072. Registered on 21st September 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043331

Background: Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer, Nanoseal, commonly used in Japan. Methods/design: This study protocol is a two-arm, parallel, pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses. Discussion: CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin-collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.