Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.
Trials. 2020 Jun 3;21(1):464. doi: 10.1186/s13063-020-04426-8.
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.
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.
UMIN Clinical Trials Registry (UMIN-CTR), ID: UMIN000038072. Registered on 21 September 2019.
This study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (Hanke, Am Dent Assoc 27:1379-1393, 1940).
牙本质过敏症（DH）是一种以短而剧烈的疼痛发作为特征的病症，这些疼痛会对触觉、化学、热、蒸发或渗透刺激做出反应。这些疼痛症状会给患者带来不适，降低他们的生活质量。最近，一种新型含锌脱敏剂 CAREDYNE Shield 被开发出来，作为一种通过诱导牙本质小管化学封闭和释放锌离子来预防根龋的新型脱敏剂。然而，CAREDYNE Shield 对 DH 的临床疗效尚不清楚。因此，本研究旨在通过与在日本常用的另一种脱敏剂 Nanoseal 进行比较，评估 CAREDYNE Shield 对 DH 的疗效。
方法/设计：本研究方案为一项双臂、平行、先导随机对照试验。将 40 名 DH 患者随机分为两组。干预组患者接受 CAREDYNE Shield 治疗，对照组患者接受 Nanoseal 治疗。主要结局是使用 5 分制语言反应量表测量从基线到干预后 4 周时空气刺激引起的疼痛强度的降低，并使用 Fisher 确切检验进行分析。
CAREDYNE Shield 可以随意应用于龈下区域和近中面，因为它只与牙体组织反应。此外，锌已被报道可减少釉质和牙本质的脱矿，抑制生物膜形成、菌斑生长和牙本质胶原降解。因此，CAREDYNE Shield 可能是一种有用的新型脱敏剂，不仅具有脱敏作用，而且还具有抑制根龋的作用。
UMIN 临床试验注册（UMIN-CTR），ID：UMIN000038072。于 2019 年 9 月 21 日注册。
本研究（方案版本号：版本 1.4.0；于 2019 年 10 月 22 日批准）正在进行中。于 2019 年 12 月开始招募参与者，预计将持续到 2020 年 11 月（Hanke，Am Dent Assoc 27：1379-1393，1940）。
